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FEATURES 10
How Technology Transform the Pharmaceutical Industry in India Sameer Bhalla, Founder, CEO, HealthIntel Services Private Limited (HSPL).
12
Helping Patients Stay on their Medication Regimen with Integrated Drug Delivery Systems Graham Reynolds, Vice President and General Manager, Global Biologics, West Pharmaceutical Services, Inc.
15
Incorporating Quality by Design in the Pharmaceutical Manufacturing Process Lum KwongToh, Regional Marketing Manager, Asia Pacific, West Pharma.
18
Techno-Healthcare: Impact of Technology on Healthcare Industry Dr Dharminder Nagar, Managing Director, Paras Healthcare.
21
Transfer of Technology - An Indian Perspective Saurabh Anand, Senior Associate, K&S Partners.
23
Unlocking Business Efficiency through Proactive Asset Management Ben Potenza, VP Marketing, EquipNet Inc.
26
A Practical Approach to Successfully Navigate the Safety and Regulatory Continuum for Mature Products David Balderson, Global Vice President - Safety Operations, Sciformix Corporation.
30
Cobots in the Pharma Industry: A Step into the Future Pradeep David, General Manager - India and Sri Lanka, Universal Robots.
32
Product Packaging and Labeling Shruti Kumbla Senior Nutritionist, Pristine Organics Pvt. Ltd.
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Pharma 4.0 – Impact of IIoT in Pharmaceutical Manufacturing Frost & Sullivan.
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Pharma Technology will be Shaped by New Challenges for Product Manufacturing Pharma technology is rapidly evolving due to requirements and challenges of new products and developments. Biologics and biosimilars and their packaging create more specialised demands for material performance. This article elaborates on the new developments in pharma technology and the Indian market playing a key role with research and development facilities being increasingly built in India.
Rahul Dev Vice President - India Datwyler 8 â—„ June 2019
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ith the increasing demands for highly sensitive drugs such as biologics and biosimilars, the requirements for drug packaging and elastomer components are ever-evolving and rapidly changing. The number of biologics stored and administered in prefilled syringes today is constantly increasing. This also triggers a growing complexity of formulations and the surge in novel device designs. Due to the sensitivity of biologics during storage and their complexity during administration, packaging requirements of biologics and biosimilars are creating more specialized demands for material performance. Consequently, market trends indicate a growth in fluoropolymer coated elastomeric closures which help to mitigate risks related to drug compatibility and stability. For therapeutic proteins, the exact chemical make-up and threedimensional conformation can influence the efficacy of the drug. As recognized by the (US) Food and Drug Administration 1 , the interaction of proteins with silicone oil can present a risk to the safety and efficacy of therapeutic proteins. Conformational changes, degradation and / or aggregation can lead to the inefficacy or immunogenicity of the protein, ultimately impeding or preventing the success of the drug. Therefore, many manufacturers of biologics or biosimilars are already relying on fluoropolymer coated closure solutions today. However, fluoropolymer coatings need special properties which make them as safe and reliable as possible. They are of particular importance to closures and components for pre-filled syringes. In storage, the drugs are in constant contact with the rubber component, e.g.
the plunger of a prefilled syringe. When it comes to silicone oil migrating into a prefilled syringe formulation, the plunger has been found to be the larger source of free silicone than the barrel – despite the fact, that more silicone oil is applied to the barrel. 2 Low levels of silicone oil particles in coatings for pharmaceutical packaging components provide advantages for every step of the way in terms of application. They not only make the products safer and more efficient; the reduction or elimination of silicone oils in rubber components and closures can also reduce time-to-market. As authorities such as the FDA recognise the risks which extractables and leachables are posing to sensitive medication, low particle levels can accelerate the approval process. Cleanroom Manufacturing as standard for state-of-the-art facilities To ensure that (coated) components for pharmaceutical packaging, particularly for biosimilars, are of the highest standard, a look at the manufacturing environment is often worthwhile. A cleanroom manufacturing environment, incorporating state-of-the-art solutions and standards, is crucial. The socalled fully integrated GMP (Good Manufacturing Practice) environment incorporates innovative automated processes and conforms to the highest industry standards. Each zone has been meticulously designed and constructed to prevent bio-contamination and is equipped with material airlocks. State-ofthe-art pass-through washing equipment Pharma Bio World
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1. Immunogenicity Assessment for Therapeutic Protein Products, GUIDANCE. Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER), August 2014. 2. Felsovalyi et al, J Pharm Sci, 2012,Vol 101(12), p 4569.
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Currently, India’s role and the role of its pharma companies are quite centered around generic medication and the delivery thereof. However, this doesn’t mean that they will continue on this path. Rather we will see a considerable shift towards establishing facilities for research and development. There are several reasons for this: one reason is certainly that the international regulatory authorities have long been observing Indian manufacturing sites closely. On the one hand, this guarantees quality products and a high aspiration for good manufacturing standards. On the other hand, it also creates the desire to further excel in production. The ambition to keep this position as a market leader is strong, resulting in more high-end and state-ofthe-art facilities. This trend is here to stay, as global companies have started to recognize the market’s potential.
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India is one of the most important drivers in the international pharmaceutical market and will continue to grow and strengthen its position. Currently, the market has the highest number of USFDA approvals and with more companies buying from Indian manufacturers, this development will continue.
Datwyler Sealing Solutions is a prime example for introducing high-end products to India. The newly built extension of the current facility in Pune already produces approx. four billion components per year. It will be fully aligned with Datwysler’s state-of-the-art manufacturing standard First Line and produce highly complex Omni Flex coated elastomer components, eg, for prefilled syringes. This investment paves the way to introducing new pharma technology to the Indian market. As a result, the market and its biggest customers will be catered to with locallyproduced components, proving that its future and perspectives are set out to be long-lasting and successful.
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India is playing a key role
Many pharma majors are merging with or acquiring Indian pharma companies and are heavily investing in Research & Development. The main focus used to be on production, but now a substantial amount of the annual profits is going into R&D investments. Many of the major global players are also setting up own R&D facilities in India. Next to generics, R&D will become a major stronghold for India in the future.
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has its automatic loading side in one zone and its automatic unloading side in a zone of even higher cleanliness. In addition, the latest generations of camera inspection techniques are used. It exceeds the most stringent quality standards of regulatory authorities and is certified to ISO 15378. All production lines operating under the First Line standard are designed to operate under a zero-defect philosophy. The process flow, gowning protocols, personnel and material flow, and state-of-theart automation all result in the lowest endotoxin, bioburden, particulate, and defect levels available in the industry.
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June 2019 ► 9
How Technology Transform the Pharmaceutical Industry in India
M
arket in general, has been greatly impacted by the might of technology and the Pharmaceutical sphere is not lagging behind. Catalysts such as Mobile communications, the cloud, advanced analytics, and the Internet of Things has influenced the way pharmaceutical industry operates, with players opening their visions to the disruptive potential. Yet many find it hard to determine what initiatives to scale up and how, making it a precarious yet enriching ally to bring on the table. Here are a few Trends reshaping healthcare: Patients are becoming more engaged In the current digital age, patients are increasingly able to take greater control of their own health, decreasing the blind dependence on prescriptions to a minimal level. They feel empowered by the vast amount of health information available online and on apps. With an array of health and fitness wearables such as FitBit and Apple Watch, consumers have grown confident in their ability to take responsibility for their health, alongside becoming keener to evaluate different healthcare products and services, making it patient engagement a key to the success of any pharma organization. Digital-centric competitors are moving in
a aa 10 ◄ June 2019
Insights into clinical pathways are no longer the prerogative of the traditional healthcare establishment, as technology companies such as Apple, IBM, and Qualcomm Technologies moving into healthcare with their vast array of solutions to aid consumers. These are able to engage with patients through apps, health and fitness devices, and online communities, collecting petabytes of data
while capturing valuable insights. Pharma companies need to optimally position themselves for competition/collaboration, while building complementary capabilities . More information is available about product performance Gone are the days of pharma companies controlling both the generation and dissemination of information as Digital technologies spurred an array of new, independent information channels for sharing and discussing patients’ experiences, advanced data aggregation and analysis to link disparate, complex data sets and generate new insights into drug safety and efficacy. Players are building channels to anticipate these new sources of evidence, and respond efficiently. Efficiency and agility is improving dramatically Advanced analytics, sensors, and the automation of complex decisions are delivering a remarkable change in the efficiency, speed, quality, and responsiveness of the pharmaceutical operations. Players are deploying nextgeneration technologies to streamline their business processes, through championing real-time transparency of their clinicaltrials and frictionless sales and operations planning, while satisfying new expectations in efficiency and agility from customers, employees, patients, and suppliers. Personalized care The ability to personalize interactions with stakeholders may have been a fodder for post 70’s science fic fares, but in the present generation, it has risen to Pharma Bio World
be a key value driver in pharma. This is facilitated through the use of sensors and digital services, providing tailored care on a monitored basis. Medication has become personalized, targeting the needs of each patient with greater precision than before. Advanced data analytics that mine electronic medical records, including diagnostic results, medication history, and genomic, proteomic, and gene-expression data are helping identify optimal therapies, while predict how individual patients will respond to treatment. Omnichannel conversations physicians and patients
with
Digital-engagement technologies open up a whole new world for marketing, the exchange of information, and recruitment for trials. Pharmaceutical sales reps, medical-science liaisons, and patientservice teams can inform and influence patients, physicians, and caregivers in person or via mobile phones, the Internet, apps, or social media. Virtual care is becoming become increasingly commonplace with specialist virtualcare apps ruling the roost. Consultation through medical portals and social media Pharma Bio World
have become a thing to vouch for as patients to use Skype to call their general practitioners. Data-driven insight: Advanced analytics to increase pipeline and commercial value Pharma companies are utilizing a wealth of data, usually locked away in different technical and organizational portals, for the growth of their trajectory. Some are already linking and mining their data sets to improve their pipelines, products, and strategies.Insights are being harnessed through use of AI to cull out valuable data that would help conjoin patient’s data to give rise to a well rounded perspective. Healthcare devices to monitor personal health and robot-assisted surgeries are direct results of successful AI integration, replacing the need for human reviewing. This in turn, has made operations and diagnosis possible on a much rapider pace, decreasing time taken to recover to a minimum level.
patient outcomes, putting an even greater pressure on pharmacy companies to demonstrate the value of their drugs in the real world to retain market access and premium pricing. In this technologically charged atmosphere, digitally enabled “an extent beyond the pill” solutions, which including not just drugs but also sensors to collect and analyze data to monitor a patient’s condition, have become the season’s favourite. These solutions are driving the adherence to treatment and outcomes that consumers and governments seek, while maintaining a delicate balance between technology and humanity. Conclusion Although these may be minor changes, but as it takes small ripples to create a storm, these too will usher in a breath of fresh air for everyone to sit up and take notice.
Outcomes-based care is moving to center stage Playersn have adopted a sharper focus on managing costs while delivering improved
Contact: monalisadas@mediamantra.in June 2019 ► 11
Helping Patients Stay on their Medication Regimen with Integrated Drug Delivery Systems e increase in selfadministered drugs is part of an even larger sift towards a more patient centric approac to te production of integrated delivery systems ecause of tis renewed focus on te patient drug delivery system manufacturers are continually reevaluating te processes by wic tey improve eisting systems and ow tey develop new ones s a result delivery system manufacturers ave become an invaluable partner to parmaceutical companies
raham enods Vice President and eneral anager, lobal iologics, West Pharmaceutical Services, Inc. 12 ◄ June 2019
A
round the world, patients with chronic diseases are seeking new freedom from frequent doctor's office visits by self-administering their critical medications at home. et with these new home-based administration plans, it can sometimes be more difficult to comply with a prescribed treatment regimen than when injectable medicines are administered by a nurse or physician. Drug delivery systems can help make self-administration a less painful, more streamlined and simplified process and help patients realize the freedom they desire. For most patients, an easy-touse, integrated drug containment and delivery system can be key to enabling the consistent routines that bring about compliance with care plans. When delivery systems are intuitive and efficient, they stand a better chance of encouraging compliance with their treatment protocol because the impact on daily routines lessens. Conversely, drug delivery systems deemed inconvenient, intimidating or complicated can negatively affect a patient's emotional attitude and motivation to sustain adherent behavior. And in many cases, looks count, too: discreetness of the drug delivery system can be very important to patients. ew integrated delivery systems can enable use without calling undue attention to the administration process, creating distractions to others or feelings of stigmatization. Such a shift from a product-centric focus to a patient-centric focus can help manufacturers design a product that encourages compliant behavior.
tting patients first in drg containment sstem design o matter what type of delivery system is selected for a particular injectable drug product, there are several elements that must be carefully considered when designing a drug delivery system. The primary goal of any drug delivery system is to ensure that a patient safely receives a proper dose of a prescribed medication. In years past, if a delivery system failed or was used incorrectly, patient error was most often the culprit. While providing detailed instructions is important for any pharmaceutical manufacturer, failure to follow directions should be minimized by providing proper training to the patient or caregivers. ow, the industry is rethinking that stance, and the priority is engineering usability into the drug delivery system to help patients achieve better outcomes. In order to design a drug delivery system that meets the needs of both the drug and the patient, the pharmaceutical manufacturer and its packaging and delivery system partner must consider the interface between the drug, container, delivery system and patient. nderstanding patients informs saiit Effective drug therapy requires more than simply having an effective molecule. ather, it is the combination of a safe drug within a suitable container and/or delivery system, as well as an understanding of patient needs as it relates to administration. Drug manufacturers should take into account four main facets of integrated drug Pharma Bio World
ensure that the stress placed on the glass does not cause breakage or that the force in the auto-injector is enough to overcome variability in dimensions, functional performance and siliconization effectiveness to ensure complete dosing. Patient Interaction - Perhaps the most essential consideration is how the patient will use the drug delivery system. Even the most innovative drug can only provide the appropriate therapeutic benefit if it can be delivered effectively and the patient adheres to the necessary treatment regimen.
Figure 1: Electronic wearable injector designed to easily integrate into a patient's lifestyle
delivery that, when planned early in the development process with a packaging and delivery system partner, can lead to better outcomes: Primary Container Format - The selection of a drug's primary container is an important consideration for drug efficacy and stability. Vials may be necessary for initial use, but a syringe or cartridge system may provide a desirable solution for the patient when the system reaches the market. Custom systems may also help to differentiate the product, and should be considered early in the development process. Drug/Container Compatibility - Hand-inhand with the type of primary container is making sure the container material can be safely and effectively paired with the drug product. Is the elastomeric material compatible with the drug? What are the levels of extractables and leachables? Will a barrier film or coating be required for the elastomer? Choosing the proper drug container material can help prevent chemical incompatibility issues that could impact a drug's purity, stability or efficacy. While glass is suitable for many Pharma Bio World
pharmaceutical products, high pH drugs or otherwise sensitive drug products may require vials or syringes made from alternative materials such as cyclic olefin polymers. The filling, handling and secondary assembly processes must also be considered as an integral part of providing the overall delivery system. Container/Delivery System Interface Once the primary container system has been selected, efforts must be made to ensure that it works with the delivery system. Dimensional tolerances and functionality should be tested to ensure proper activation and gliding forces. If the interface between the primary container and the delivery system is not effectively understood, the performance of the combined system may suffer. For example, when considering the use of a glass prefillable syringe in an auto-injector, manufacturers must
Simply designing a drug delivery system that patients/users "can" use, is no longer sufficient. Delivery systems should be designed for affinity, and encourage patients to "want" to use them. Even then, effective training, onboarding, and ongoing adherence are critical to ensuring effective outcomes. Forward-thinking partners make the difference for patients West's SmartDose platform is a singleuse, electronic wearable injector that was designed to easily integrate into a patient's lifestyle. The discreet, wearable technology adheres to a patient's body, usually on the abdomen, and is designed to minimize discomfort. The SmartDose platform currently incorporates a polymer-based drug container (made from Daikyo Crystal Zenith cyclic olefin polymer) with a drug delivery system that can be pre-programmed to deliver high volumes of sensitive drug products, making it easier for patients to self-
"When delivery systems are intuitive and efficient, they stand a better chance of encouraging compliance with their treatment protocol because the impact on daily routines lessens." June 2019 â–ş 13
comply with their prescribed treatment regimen. Connected health innovations like this help to boost motivation by incorporating game-like technology that enables short-term rewards for patients, by tying rewards and education to the drug administration process. A drug can only truly have the desired patient benefit if it is taken as prescribed, delivered effectively and maintains performance over time. Together, drug delivery system and drug manufacturers can work seamlessly as partners to provide innovative solutions that help mitigate risk, improve patient outcomes, and enhance value through unique integrated delivery combinations.
Figure 2:Electronic wearable injector
administer medication outside of the clinical setting. West is currently collaborating with HealthPrize Technologies, LLC-a
leader in digital solutions for patient engagement and medication adherenceto enable connectivity between a variety of injection systems and their adherence programs, to help motivate patients to
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Incorporating Quality by Design in the Pharmaceutical Manufacturing Process The current pharmaceutical market has faced a variety of challenges, including increasing expectations for quality from endusers and regulatory agencies driven by concern for patient safety. The pharmaceutical and biotech industry as a whole has had a series of regulatory challenges relating to issues such as lack of cGMP compliance, high end-of-line rejections and lack of best practices for compliance in general. Such incidents can cause drug shortages, which also have a direct impact on meeting patient needs. The cost for such issues to both companies and patients is significant.
I
ndustry suppliers play a critical role to help pharmaceutical manufacturers meet the needs of patients and regulators. As the industry evaluates the adoption of Quality by Design (QbD) techniques as a way to address these challenges, it needs to turn its focus from ascertaining drug product quality predominantly by end-product testing to achieving effective and efficient manufacturing processes by harmonising pharmaceutical development, quality risk management and pharmaceutical quality systems through science-based quality manufacturing. The goal during QbD development is to have predefined objectives with emphasis on the product and understanding the manufacturing process. An in-depth understanding of container closure components along with their manufacturing process will enable science-based decisions to support pharmaceutical manufacturing control strategies. Aspects of container closure systems critical to drug product quality can be established during the drug development cycle by identifying potential attributes of the component and applying various risk management tools. It is possible to combine and coordinate process knowledge from multiple-unit operations to achieve a holistic picture of the entire drug manufacturing process, which can incorporate the science of component manufacture. An understanding of how drug formulation and component manufacturing process factors affect quality will lead to:
• Lum KwongToh
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Effective technology that will reduce setbacks when moving from development to commercialisation, realising time and cost savings
•
Data-driven knowledge to identify critical quality attributes and establish control strategies • Specifications based on how and why the rubber formulations, components and process factors impact drug product quality • Benefits throughout the lifecycle of a given product through trending of data for proactive management and effective continuous improvements Elements of the QbD Approach The importance of the container/ closure system to the efficiency of the manufacturing process and the quality of the final drug product is significant and should not be minimised. The QbD approach takes into consideration the entire supply chain from raw materials through distribution and drug packaging. Quality characteristics are engineered to meet the requirements of the pharmaceutical manufacturer and help promote protection/compatibility of drug product. There are three critical elements to a true QbD pharmaceutical product. These are: • Drug product • Drug manufacturing process • Container/closure system Convergence of these three operations is vital to establishing the critical quality attributes necessary for control of the drug product and the process to enable continuous improvements (See Figure 1). The following important QbD elements can be used to develop and produce June 2019 ► 15
Consideration of all these factors during development of elastomeric components can achieve a well-understood component and robust processes that 1) deliver a component meeting the QTPP and 2) are controlled by defined steps within the manufacturing process. During commercial-scale manufacturing, the proactive trending of component performance on a continuous basis provides a major advantage through early detection of potential issues and further optimisation of the control strategy to ensure reliable level of highquality components. Managing Total Cost of Ownership
Figure 1.
QbD delivers an improved, data-driven output providing manufacturers with superior product and process understanding that minimises process risk, emphasises patient-critical quality requirements and enhances drug product effectiveness components with a commitment toward enhancing drug product quality:
• • • • • • • •
Quality Target Product Profile (QTPP) Critical Quality Attribute (CQA) Quality Risk Management (QRM) Knowledge Management (KM) Critical Process Parameter (CPP) Control Strategy (CS) Lifecycle Management (LCM) Continuous Improvement (CI)
The QTPP forms the basis for drug product formulation and process development in a QbD framework. A series of considerations should be made for the QTPP of a sterile product. Some of these considerations include the desired product performance based on the intended clinical setting, dosage strength and delivery mode,
16 ◄ June 2019
pharmacokinetic characteristics, drug product quality criteria, sterility and the container closure system itself, just to mention a few. Scientific rationale and quality risk management are used to define CQAs and CPPs for a given product and process in support of achieving the QTPP. The information developed to determine the CQAs and CPPs will help to: • Develop control strategy • Ensure quality of the product throughout the product lifecycle • Increase product and process knowledge • Increase transparency and understanding for regulators and industry • Evaluate changes
As the industry evaluates its Total Cost of Ownership (TCO) model, it will begin to adopt QbD techniques. Such an adoption requires a significant up-front investment. However, QbD delivers an improved, data-driven output providing manufacturers with superior product and process understanding that minimises process risk, emphasises patient-critical quality requirements and enhances drug product effectiveness. A more efficient process results in a final deliverable that is a much higher quality product with well-understood and controlled sources of variation. (See Figure 2) When industry evaluates its Total Cost of Ownership model, the importance of the use of a primary package component that has been developed and produced by QbD techniques should be a significant consideration. Such a product will minimise variability downstream by pushing improved understanding and controls upstream into the supply chain. Risks such as end-of-line rejects, loss of production capacity and compliance inadequacies will be minimised, driving cost of ownership down significantly. The adoption of QbD by suppliers to the industry is the future. Although some pharmaceutical companies are still
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and are accountable for assuring the inputs into the finished drug product are of highest quality.
Figure 2.
The use of components based on a holistic QbD process assures the company it is using a well-understood product that has been developed to achieve highest patient safety and lowest risk for the pharmaceutical manufacturer. grappling with the adoption of this new model, forward-thinking suppliers have already implemented this technique. Products have been developed using the systematic, science-based approach encouraged by the regulatory agencies. Such a development process can deliver a product to the industry that provides the ultimate product and process understanding; has quality built around the patient; improves transparency; and provides improved Total Cost of Ownership to the pharmaceutical customer. Total Cost of Ownership is the analysis of price, risk, quality, service and delivery performance in evaluating the overall cost of a product versus its benefit. If the use of a certain product solution can minimise manufacturing downtime, lower end-ofline rejections, minimise compliance and regulatory risks, and provide other related benefits, then the positives associated 18 â—„ June 2019
with this product are worth an incremental price differential. End-of-line rejections due to component defects are an example where Total Cost of Ownership benefits can be clearly recognised for the pharmaceutical customer. In a case study, a move to an improved component allowed a customer to reduce rejections from 0.75 per cent of all filled vials to 0.02 per cent . Not only is this a significant cost savings in dealing with the rejected drug product and its final disposition, it allows more product to go out to market for use. This minimises concerns with product shortages in the field, helps to manage capital expenditures more effectively and ultimately allows more revenue to be generated for the pharmaceutical or biotech company.
The use of components based on a holistic QbD process assures the company it is using a well-understood product that has been developed to achieve highest patient safety and lowest risk for the pharmaceutical manufacturer. At the center of a Total Cost of Ownership analysis by the company must be hard-dollar savings coupled with the consideration of significant savings in dealing with fewer regulatory and quality challenges, potential loss of revenue and the long-term negative impact to brand equity. Additionally, if saved resources can be better applied to other areas of the business, the potential benefits are exponential. Suppliers that provide components critical to the drug manufacturing process or drug product should consider QbD as a critical input to the pharmaceutical supply chain as it directly supports a lower Total Cost of Ownership model. References: (1) ICH Quality IWG Points to Consider Guide for ICH Q8/Q9/Q10 Guidelines (2) Nasr, Implementation of Quality by Design (QbD) - Current Perspectives on Opportunities and Challenges Topic Introduction and ICH Update Office of New Drug Quality Assessment www.fda.gov/downloads/AdvisoryCommittees
Contact: alok.chandorkar@westpharma.com
(This article was originally published in May 2014 issue of Pharma Bio World.)
Regulatory expectations are that pharmaceutical and biopharmaceutical companies understand their supply chain Pharma Bio World
Techno-Healthcare: Impact of Technology on Healthcare Industry From improved operational efficiency to standards in patient care, the healthcare transformation has enhanced the entire experience for both patients and medical professionals. This article discusses the healthcare industry trends and innovations that are revolutionising the field.
I
n today’s world, technology plays a crucial role in the functioning of every industry and has made our lives totally different than before. Out of all the industries, technology plays one of the most dynamic roles in healthcare industry. The advent of techno-healthcare, promises to improve and save countless lives all around the world. Techno-healthcare is a broad field where innovation plays a crucial role in sustaining health. Areas like biotechnology, pharmaceuticals and information technology along with the development of medical devices and equipment have made significant contributions to the healthcare industry. From development of adhesive bandages and ankle braces to complex more innovations like MRI machines, robotic prosthetic limbs and artificial organs, technology has made a remarkable impact on healthcare. Doctors are able to carry out better diagnosis, surgical procedures, and improved patient care due to technology. The change is palpable with the way doctors and patients interact with each other nowadays. Doctors are increasingly adopting technology like using notepads to take down and save patients’ history. Mobility
Dr Dharminder Nagar Managing Director Paras Healthcare Pharma Bio World
With doctors and hospitals incorporating technology in their systems, more and more fuctions are carried out effortlessly and efficiently. Physicians have been given the gift of mobility. Doctors now have access to all kind of information required, be it drug information, research or studies, patient history or records and much more, within mere seconds. With the ability to effortlessly carry mobile devices around throughout the day, information is never too far from them. Devices that aid
in identifying potential health threats and examining digital information like x-rays machines and CT scan machines also contribute to the benefits that information technology brings to healthcare. Analytics Predictive algorithms hold immense potential in solving some of the acute problems faced by the healthcare system and delivery in India. With this technological development, doctors are able to diagnose their patients more precisely. Analytics are being applied in other countries for diagnosis and the same technology can be adopted in India. This helps the doctors in discovery of a new source of data which helps them draw the complete picture about the diseases of the patients. This also makes possible the complete analysis of a medical problem like diabetes or any other problem and then find a revolutionary solution. Digital The push towards digitization augers well for the healthcare industry. Digitization is helping in conversion of patient records from paper driven to electronic storage systems. This is resulting in more efficient delivery of healthcare to the patients as their medical history and even treatment is no longer tied to one location and can be sent for reference and cross checking to any part of the world in no time. With Aadhar number linkage of the health records of the patients, there will be further simplification of the process of getting OPD appointments in hospitals. Patients need not stand in long queues and just need to mention their Aadhar numbers and forego the process of registration at hospital counters. June 2019 ď‚„ 19
Patient Care Another key area that has benefited from techno-healthcare is patient care. The use of information technology has made patient care much more reliable at hospitals. Nurses and doctors working at the frontline now regularly use hand-held computers to record important real-time patient data and then share it instantly within their updated medical history. It is an excellent contribution of technology to health care industry. Being able to store lab results and other crucial patient data at one centralized area has altered the level of care and efficiency a patient can expect to receive when they enter the hospital. Medical Research An improved level of efficacy in data collection means that an immense pool of patient history and case studies is now available to scientists online, who
can easily study extensive patient case studies and make medical breakthroughs at a faster rate. Scientists and physicians are persistently conducting research and finding new procedures to prevent, diagnose and cure diseases in a more efficient way and develop new drugs and medicines that can reduce the symptoms or treat ailments in a quicker way. Vaccines Through the use of technology in medical research, scientists have also been able to study and examine diseases on a cellular level and produce vaccines against them. These antibodies against life-threatening diseases like malaria, polio, MMR, etc, prevent the onset of diseases and save millions of lives all around the planet. In fact, according to World Health Organization estimates, vaccines save about 3 million lives each year and prevent million others from
contracting deadly viruses and diseases. Advancements in technology have rendered an extraordinary impact on the healthcare industry and dealing with medical problems has never been easier. Physicians are able to better diagnose and treat their patients, ever since the beginning of the professional practice of medicine. Scientists and researchers are able to formulate better medicines and vaccines, thanks to the resources made available by technology. Countless lives have been saved and the overall quality of life continues to improve over time owing to the growing scale and size of technohealthcare industry.
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Transfer of Technology - An Indian Perspective Technology transfer is the process of transferring scientific findings, knowledge,manufacturingprocess, technologies, processes etc. from one organization to another for the purpose of further development and commercialization. This article discusses the Indian scenario concerning transfer of technology.
Saurabh Anand Senior Associate K&S Partners Pharma Bio World
O
ne of the most acceptable and unambiguous definitions of “Technology Transfer” or in other words “Transfer of Technology” is the process by which “commercial technology” is disseminated from one industry to another, and/or among different economies. In common parlance, the said terms are often misconstrued to be limited only to the transfer of a patent with respect to a particular product, which is patented. Meaning thereby, the product of the technology is often fused with the technology itself. However, in actual commercial terms, technology is often considered to be a blueprint, which once obtained would promise better commercial output and it largely depends upon the industry. For instance, in mechanical industries, transfer of technology might include transfer of an end product, involving multiple IP rights. However, for pharmaceutical industries, transfer of technology might include transfer of know-how of a process to obtain a product, which will not always be a fullfledged transfer of IP rights, as certain IP rights will be developed upon development of that particular product. Thus, getting a patent is not always a pre-requisite for initiating or rather indulging in a “Technology Transfer” arrangement. This dynamic model often creates multiple hurdles for a transferor to enter into such transactions, due to the vulnerability of the “technology” at the whims and fancies of the transferee. This is often observed in cases of transborder transactions, wherein the transferor who wishes to expand its footprint in a particular country, is hesitant to enter into such kind of arrangements due to the lack of confidence in the laws governing the importing country. However, at the same time such transfer of technology is often required to give a technological as well as economical boost to the importing country in an era wherein technology is changing
overnight and the thrust of adopting to changing technologies is also increasing at the same pace. At this juncture, the laws of the importing country play a vital role in preparing a ground to facilitate such transactions. Undoubtedly, strong IP laws play a crucial role for any transferor to prefer a particular jurisdiction over another, but simultaneously enforcement of such laws in order to protect the IP becomes the game changer. For instance, mere mention of provisions for remedies in cases of infringement would no doubt portray a positive image of the importing country and at the same time if such statutory provisions have actually been implemented by way of granting injunction or directing to pay for damages and so on, it definitely acts as a springboard for the transferor to actually start investing in such importing countries. Section 83 of the Indian Patents Act, 1970 which is in consonance with Article 7 of the TRIPS Agreement recognises this concept as under: General principles applicable to working of patented inventions. – Without prejudice to the other provisions contained in this Act, in exercising the powers conferred by this Chapter, regard shall be had to the following general considerations, namely:• that patents are granted to encourage inventions and to secure that the inventions are worked in India on a commercial scale and to the fullest extent that is reasonably practicable without undue delay; • that they are not granted merely to enable patentees to enjoy a monopoly for the importation of the patented article; • that the protection and enforcement of patent rights contribute to the promotion of technological innovation June 2019 ► 21
and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations; Thus, the Indian Patents Act, recognises the twin-benefit of Technology Transfer, that is, encouragement of innovation as well as protection and enforcement of patent rights. In addition to IP laws, the strength of ancillary laws like contractual laws, regulatory laws and so on, play a critical role in aiding such transactions. Further, various Government initiatives like FDI, tax exemptions, fast approvals, digitalization and the like are other factors which provides the impetus for Transfer to Technology. For instance, the pharmaceutical sector is one of the key 25 sectors identified by the Government of India under the ambitious ‘Make in India’ initiative, which is likely to provide the necessary momentum to the sector in order to achieve its true potential. Following this, is the nod by the Union Cabinet for FDI up to 100 percent under the automatic route sector for manufacturing of medical devices subject to certain conditions. Further, the implementation of the Goods and Services Tax (GST) is expected to be a gamechanger for the Indian Pharmaceuticals industry as it will lead to tax-neutral interstate transactions. Till date, the Government of India has undoubtedly taken multiples initiatives towards improvements in the pharmaceutical sector however, they are mainly restricted to just that and do not focus on the concept of technology transfer to reduce the amount of input in such an industry. For instance, in the Union Budget 2017-18, the Department of Biotechnology (DBT) received Rs. 2,222.11 crore, an increase of 22 per cent, to continue implementing the Department’s National Biotech Strategy. Later on, in an attempt to revive the active pharmaceutical ingredient (API) and the bulk drug market in India, the Government of India has proposed peak 22 ◄ June 2019
customs duty on the importing of APIs and also plans to establish mega drug parks to promote domestic production. It has also unveiled ‘Pharma Vision 2020’ aimed at making India a global leader in end-to-end drug manufacture. Approval time for new facilities has been reduced simultaneously to boost investments. The Government has also introduced systems such as the Drug Price Control Order and the National Pharmaceutical Pricing Authority in order to deal with the issue of affordability and availability of medicines. Against this backdrop, it is imperative to note that the concept of technology transfer can greatly help in reducing the cost of R&D in this sector if the government also provides incentives for the same especially since there has been a six-fold increase in the cost of R&D in this sector since 2010. The high cost of development and rapid obsolescence may prevent the transfer of technology and the patent holder may prefer direct exploitation or import of products over transferring the technology or know-how. Fear of competition also dissuades the transfer of technology or demands a high royalty for the transfer, but huge royalties may have a negative impact on the expenditure on R&D. In the case of India in the pre’70s era, technology transfer by the big MNCs did not support indigenous technological abilities, although post ‘70s, a large number of small and medium size firms have also been transferring their drug technologies to India, thus encouraging an atmosphere of competition in technology transfer. The Ministry of Science and Technology has issued the guidelines “Instructions for Technology Transfer and Intellectual Property Rights”, which would help in enhancing the motivation of scientists, research institutions and universities in projects funded by the Department of Science and Technology, Department of Biotechnology, Department of Scientific and Industrial Research and Department of Ocean Development. The salient features of the guidelines are limited to ownership,
commercial exploitation, royalty, norms for private industry, royalty free licenses for the government as well as patent facilitating funds. India at this point has an immense potential for becoming a booming ground to facilitate and nurture the benefits of technology transfer. However, there exists a dire need to address this with guidelines to govern the same. The goals of technology transfer will only truly be met and be expected to cater to the needs of the public if there is a greater involvement of the Government. Despite the above, Government of India is on the verge of opening Technology Transfer Offices, universities, institutions that will be funded by the Central Government and will act as mechanisms for transferring or exporting the research conducted and its outcome to the desired place. It is pertinent to note that some Indian institutes such as the National Chemical Laboratory, Pune, CSIR-CDRI, have already been commercializing their research and have been successful in entering into technology transfer agreements vide which they have been licensed as technologies to industry. It is only with adequate legal framework, guidelines and an increase of awareness that the issues of technology transfer can be encouraged. Although a number of Indian firms have been the receivers, a greater need of boosting this within the domestic markets is the need of the hour. References: Rosegger. G “The Economics of Production and Innovation: An Industrial Perspective” (Oxford: Butterworth-Heinemann Ltd), 1996, p. 155-156 h t t p s : / / w w w. i b e f . o r g / i n d u s t r y / pharmaceutical-india.aspx http://www.pfc.org.in/info/tt_ipr.htm
Contact: sanand@knspartners.com Pharma Bio World
Unlocking Business Efficiency through Proactive Asset Management This article discusses how the processes of asset redeployment, as well as the buying and selling of surplus and idle laboratory and production instrumentation can benefit the pharmaceutical industry.
T
he global pharmaceutical market is growing 7.8 per cent year on year and is estimated to be worth around USD 1.6 trillion by 2020. As the world's population continues to grow and age, so will this industry 1. At the same time, pharmaceutical companies are facing a range of challenges which are forcing them to reduce both time to market and costs. For instance, more stringent healthcare regulations are being introduced and payers are putting pressure on companies to adapt their pricing policies and commercial models. Mergers and acquisitions are becoming more common-place, which means that equipment can fall out of use even though they remain valuable for a variety of uses such as drug discovery, manufacturing and the packaging of commercially available products. Additionally, new products are constantly being launched across the sector, meaning that instrumentation needs are also evolving. An Innovative Solution
Ben Potenza VP Marketing EquipNet Inc. Pharma Bio World
An increasing demand from pharmaceutical businesses for low-cost laboratory and manufacturing instrumentation solutions has resulted from the need for companies to focus on leaner production, as well as meeting the fluctuations in demand. These pharmaceutical companies are now beginning to purchase high-quality, used equipment in order to expand into new production areas, as well as to maximize budget; it is common to save between 50-75 per cent of the cost of new instrumentation. Furthermore, the advantage with purchasing second-hand equipment is that
it is often available immediately, unlike new instrumentation 2. In order to obtain returns from surplus machinery, time and expertise is needed. Many pharmaceutical companies do not have this however and implementing a partnership with a specialist provider can help to execute an asset management strategy. These asset management experts can provide useful information on budgets, specification and risk mitigation (how reputable a supplier is, for example). Industry experts can then guide companies through the purchasing process by helping them to obtain existing warranties on equipment and provide follow-up support allowing an efficient process for the purchaser. EquipNet provides a holistic approach to surplus asset management for both buyers and sellers and this is illustrated in the EquipNet 'Value Control Model' (See Figure 1 on next page), which is based on time and can be customized using a central tracking platform. This provides communication and workflow tools and ensures the exposure of all assets throughout a business. A variety of disposition channels, which include redeployment, negotiated sales with managed pricing through an online market and competitive auctions can also be used. Other options include clearance, disposal and scrap programs, which can be customized for each specific customer. To redeploy equipment and keep track of surplus assets, partners should possess a reputable software platform to list assets across a business. A company can then view all equipment across a variety of locations worldwide. June 2019 â–ş 23
Redeployment Redeployment of instrumentation allows businesses to gain the highest possible value from equipment and is hard to achieve without a central tracking platform. This software allows users to post, track, identify and then internally redeploy an instrument that is laying idle or not being used in its current location. Should this not be possible a company can then decide whether the external sale of equipment or the purchase of another instrument is necessary. A proven example of a tracking platform used within this market is EquipNet's Asset Redeployment Management System (ARMS') platform, which features workflow management and multiple access levels for employees across a business, including plant managers and executives. ARMS can provide in-depth information on the equipment a business currently owns and which site it is located at. Looking to Sell? Should the redeployment of an asset not be possible, a company should then look to sell the instrument. An auction is a reliable way to sell equipment. Dealing with the auction process however is difficult and success depends on a number of factors. An asset management partner can provide advice on how to approach this process for each individual customer.
24 ◄ June 2019
Therefore, using a company with specific industry experience and a good reputation is important. Options can include online auctions, live/webcast auction events, sealed bids and private treaty events. Further customized solutions for selling equipment include EquipNet's MarketPlace platform. MarketPlace lists used equipment available for purchase, however, in contrast to auctions, which are scheduled events for selling a large group
Pharma Bio World
of used equipment from client facilities, MarketPlace allows price negotiation for an instrument at anytime. Should it not be possible to redeploy assets as they have little or no value, clearance by donations, scrap and environmental recycling are the best options. It can be the case that the scrap value of idle equipment can achieve the highest return. It is common for EquipNet to advise clients in this area. The purchase of second-hand equipment Pharmaceutical companies now face the ever more difficult challenge of meeting rising demand, as well as more rigorous commercial targets. All kinds of businesses are now taking advantage of the savings to be made from purchasing pre-owned equipment from top-tier manufacturers. This is in contrast to constantly buying new instrumentation.
Buyer companies therefore, often invest in high-quality second-hand instrumentation in order to maintain a low cost-base while continuing to improve company processes and services. Asset management partners can inform businesses of appropriate auctions, as well as how to use negotiated sales platforms such as MarketPlace. Collection and delivery are all that need to be organized following the purchase of equipment. Summary
also able to purchase unwanted, highquality equipment for a fair price. An asset management partner can therefore provide important solutions for companies looking to redeploy, sell and purchase surplus assets. Reference PwC-http://www.pwc.com/gx/en/industries/ pharmaceuticals-life-sciences/pharma-2020/ vision-to-decision.html NiceInsight-http://www.niceinsight.com/articles. Contact: tmg@scottpr.co
As the pharmaceutical sector continues to grow, businesses are keen to further reduce time to market, as well as costs. Redeploying and selling equipment with a reliable asset management partner can help businesses obtain the maximum returns on an instrument, as well as ensure operational efficiency. Buyers are
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A Practical Approach to Successfully Navigate the Safety and Regulatory Continuum for Mature Products ature harmaceutical roducts are those that are long ast their mareting eclusiity eriod but are still sold in substantial olumes because of their ellestablished effectieness and safety in certain medical conditions. ature roducts hae a significant role in the healthcare for many atients both in the deeloed and deeloing orld. The maority of the large harma comanies hae a sieable ortfolio of mature roducts, hich are in the final stages of their lifecycle although they may be mareted or sold for many years to come. These roducts can still lay a crucial role in the comanys strategy, more so in emerging marets than in innoationfocused, deeloed marets.
W
hile development of promising new products is an obvious area of focus for biopharmaceutical companies, maintenance of already established marketed products is a critical activity that cannot be ignored. Ensuring regulatory compliance and reducing product risk whilst still working within the cost constraints presents unique challenges to companies in managing established products and requires innovative and cost-effective approaches that can help ensure patient safety and compliance while continuing to meet ever-increasing and complex regulatory demands. Rather than handling all products in the same way, marketing authorization holders (MAHs) have an opportunity to look at managing the more stable mature products differently and more efficiently, allowing them to consider the benefits of an integrated safety, regulatory and benefit-risk model.
for individual market needs, innovating the formula, dosage forms or packaging for optimal results, or expanding geographically. Yet, due to increasingly stringent drug regulations in emerging markets, the documentation needed to remain compliant for mature product maintenance has risen dramatically in the last decade. Pharmacovigilance (PV) activities must be continued, while maintaining regulatory dossiers and managing labels is all required to uphold licenses. on-compliance can result in critical regulatory penalties, with significant financial implications. The most significant financial impact for any manufacturer is when blockbuster drugs pass their patent exclusivity, requiring most companies to look carefully at minimizing costs to sustain their profitability. A Pragmatic Approach to Managing Mature Products
The Importance of Mature Products Mature products, those that are still sold substantially but are long past their marketing exclusivity, have a significant role in the healthcare industry in both the developed and developing world. Mature products make up a large portion of many pharmaceutical organizations portfolios these are likely to be sold well into the future despite being in the final stages of their lifecycle.
Daid alderson Global Vice President - Safety Operations Sciformix Corporation 26 ◄ June 2019
Established products have proven effectiveness and safety profiles making them even more important in emerging markets compared to newer products. However, since the cost of maintaining mature products is usually significantly lower than launching newer ones, pharma companies can focus on tailoring them
Organizations have the opportunity to manage their mature products differently from others in their portfolio by focusing on efficiency to free up resources. Mature products, by nature, are typically more stable with a predictable revenue stream, thus, the reduced amount spent on managing the product can increase profitability. A more pragmatic approach can be taken to streamline processes making it less resource intensive. In some aspects, such as the frequency of Periodic Safety Update Reports (PSUR) production, the regulations also support a more streamlined approach and although aspects such as signal detection activities need to be maintained, there are opportunities to take a more pragmatic approach by reducing the frequency of many routine activities. Pharma Bio World
Figure 1. The Safety Continuum There are three main areas to traverse when managing mature products, namely, safety and risk management, labeling and regulatory. Taking an integrated approach for these three areas is vital to efficient management. Yet, often these functions can act independently within organizations which can result in overlapping and duplicative work or in worse case scenarios some elements being missed completely, due to fragmented processes and oversight. Furthermore, with the evolution of Good Pharmacovigilance Practices (GVP) in Europe and many other regions following suit, more rigorous standards need to be upheld. This requires a substantially skilled manpower pool who are knowledgeable of each region's regulations, which often means stretching the same resources between mature product portfolios and new products. Pharma Bio World
The Safety Continuum Whilst mature products are often much more stable and well defined than new ones, safety activities are still required, although usually under less scrutiny. These are done to ensure the product remains safe and effective for patients. PV is a central function to supporting the safety of a product and ensuring the benefits out-weigh the risks of using the drug. It is acknowledged that some products, across multiple classes that have been on the market for a long time, still require extensive support from a PV perspective. These include clozapine, thalidomide, isotretinoin, and leaner approaches to managing these products are not applicable. However, even the majority of the stable mature products can still go through many changes due
to increasing exposure, differences in physician practices, new or untested drug interactions and pharmacogenetic variations as they are introduced to new patient populations. A variety of activities are therefore still required, along with risk management plans that may go beyond routine PV. These activities from single adverse event processing to signal identification and risk management are part of the safety continuum, which is illustrated in the figure below. Signal Management Signal management can be defined as the activities performed to identify new risks or changes in character or severity of a known risk. It remains an essential component in assuring the safe use of a drug throughout its lifecycle. Avoiding and minimizing risks can be done through alerting patients and June 2019 â–ş 27
Figure 2. The integrated safety, regulatory and labeling continuum. healthcare providers to the identification of a new risk or change in a known risk. This requires discussion with regulators, changes to labels and occasionally direct communications. This can often include a spectrum of teams in an organization from PV, to clinical development, to regulatory affairs and medical information, especially if the communications become urgent. Even for mature products, signal management remains an essential part of the safety continuum and product lifecycle.
and, at times, essential information to regulators, patients and HCPs, regarding the safe use of a product. Label changes are also a complex procedure involving cross-functional processes, requiring written safety practices and high level expertise. For mature products there is normally a large amount of safety data that needs to be managed efficiently. In order to complete a safety driven label change, an organization must have written practices in place to organize the different functional groups with the required expertise.
Signal Detection to Implementation of the Label
The Regulatory Continuum
A label change is an example of a truly collaborative and cross-functional process which has a high degree of operational complexity and is often an outcome from signal management, subsequent to the validation of a safety signal. The label change communicates formally important
Regulatory submissions are often time intensive and require multiple teams and stakeholders to fulfil, but for mature products the strategy for filing is often managed regionally or locally, requiring an understanding of the local environment. However, in order to manage the
regulatory activities, the local regulatory resources still require documentation and support from central regulatory experts who are often unable to dedicate time to supporting mature products as the focus is on the new product portfolio. With this and the increasing pressure to be cost and time efficient, new operating models and adapted standard operating practices (SOPs) need to be considered. Typically these allow local or regional regulatory professionals to manage activities themselves by re-purposing documents that have been created centrally. Dossier Repurposing
28 â—„ June 2019
When maintaining mature products, some key strategies allow for expedited safety labeling and regulatory procedures. The first of these is dossier repurposing, which consists of reusing and reformatting the existing dossier submitted in highlyPharma Bio World
regulated countries to then meet regionspecific requirements. Obtaining regulatory approval of new uses for existing drugs is an important part of innovating mature products. Sections of existing dossiers can be repurposed, along with the creation of any additional content needed to meet the specific requirements in order to file applications for mature products with wellestablished safety and efficacy profiles. This includes changes from prescription to over the counter drugs.
Mature Product Lifecycle Management
License Maintenance and Renewals
Outsourcing regulatory and safety activities for mature products is a viable option and can streamline the process while minimizing costs. A partner can employ a centralized approach and is able to communicate with multiple teams globally and efficiently manage data to fully coordinate operations. Ideally a partner should manage the end-to-end safety and regulatory deliverables to support mature products, however, a flexible model can be employed if required. A dedicated and integrated team is able to proactively manage risks, including generating risk management plans and risk mitigation strategies. They are also able to track regulatory commitments, such as US FDA annual reports and PSURs, and ensure all deliverables are submitted on time.
MAHs of pharmaceutical products are responsible for validating the effects of any manufacturing or product quality (generally CMC) related changes to the identity, strength, quality, purity, and potency of the drug as these factors can affect the safety or efficacy of the drug. CMC changes are a significant source of license maintenance activity and are inevitable due to many reasons including continuous process improvement in manufacturing and quality of the product, changing business needs, or implementation of regulatory authority stipulations. Deviations or violations from filing such documentation can result in regulatory actions such as warning letters and import alerts. License renewals are also required periodically to continue marketing a drug. In order to keep a continuous supply of product these activities must be managed ahead of drug license expiration dates and site registrations. An Integrated Safety, Regulatory and Labeling Continuum for Mature Product Maintenance Organizations should consider the merits of an integrated safety, regulatory and labeling service model for mature product maintenance with a flexible structure that promotes continuous improvement, whilst lowering the costs and maximizing product value. The figure below illustrates an example matrix of the different activities that need to be managed within an integrated framework. Pharma Bio World
A meaningful way to address the challenges in today's complex regulatory environment is to focus on an integrated team approach to product lifecycle management. Most pharmaceutical companies suffer from building virtual walls between functional silos, along with data and processes being separated, thus, making it difficult for cross-functional information to flow quickly and securely.
Furthermore, for generic products the regulatory intelligence capabilities of an outsourced vendor can be leveraged to track and implement updates to the reference label.
was implemented at a large generics company to manage their product portfolio. With the client's products being manufactured at various locations worldwide, and teams located in different geographies, the main challenge was to manage the data generated across the different locations and coordinate regulatory submissions. A dedicated crossfunctional team with in-depth knowledge of the product portfolio, various regulatory information management systems, and publishing tools was assigned to the project. Data was collated into a single repository that allowed for early identification of potential risks, the ability to quickly address emerging problems, improved efficiency, and reduced the need for regulatory oversight from the client. The reliance on input from the client has reduced over time and they are being successfully supported through this integrated model. Conclusion Whether product lifecycle activities are managed internally or by a service provider, creating a structure in which all elements (people, process and technology) are integrated is critical to being able to successfully manage mature products efficiently. This allows all stakeholders to be aligned and companies can streamline tasks and free up resources to focus on other activities.
As with any outsourced model, internal resources would still be required to manage relationships with the vendor and provide access to necessary data, over time this will diminish and the provider will be able to manage the safety and regulatory activities to support the entire mature product portfolio in a much more independent manner. An integrated regulatory, safety, risk management, and product labeling model
Contact:David.Balderson@Sciformix.com June 2019 â–ş 29
Cobots in the Pharma Industry: A Step into the Future
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utomation in its broadest sense has expanded from its original industrial manufacturing base to laboratories and businesses. The application of robotics and automation has been successfully achieved in a wide range of industries dealing with well defined processes and products like the manufacturing industry, F, automotive industry, the healthcare industry, the pharmaceutical industry, to name a few. Technological advancements have revolutionized automation to the current level of complexity and flexibility even so, the pharmaceutical industry faces a few issues like the commercial environment is getting harsher, as healthcare payers impose new cost constraints on healthcare providers who scrutinize the value medicines offer much more carefully. This leads to a sharp rise in the customer expectations for newer therapies, which are economically better than existing alternatives, while being medically superior. The industry output has remained at a stable level for the past decade. Using the same discovering and developing processes, there's little reason to think its productivity will suddenly soar. astly, the prevailing management culture, mental models and strategies on which the industry relies are traditional, even though they've been eclipsed by new ways of doing business, leaving a huge margin for human error.
a a eneral anager - India and Sri anka Universal Robots 30 ◄ June 2019
The many benefits of automation include efficiency, saving workers from hazardous environments or repetitive tasks, reducing training overhead, eliminating human error, increasing repeatability, reproducibility, and in clean-rooms, removing the potential for human contamination.
Automation also improves compliance and minimizes deviations by connecting instruments to electronic systems, so users don't have to manually enter data. loud- based software, with appropriate security protocols can be adopted to facilitate integration and automation. This reduces the paper work of the companies, making data manageable. Robots, as are being introduced into every industry, the pharmaceutical industry too has begun adopting robotics in production and distribution. A study by the Association for Packaging and Processing Technologies PI found that robots are expected to handle 3 per cent of primary pharmaceutical packaging operations in USA by 201, compared with 21 per cent in 2013. An increase in the use of robots is seen in dispensing, sorting, kit assembly, and light machinetending as well as in more traditional applications associated with packaging. The global use of robotics in the Pharma sector has invariable increased in the past couple of years. ith the idea of higher production rate and the need for human interaction with machine automation, the ollaborative robots were first developed in 200 by Universal Robots. Universal Robots are the leading manufacturers of advanced userfriendly and light industrial robotic arms from Denmark. Their latest technological advancement in collaborative robots or 'o-bots' was brought out in the international market with a peculiar intention which is in line with Industrial .0 which is in sync with the automated revolution in the Pharma industry. Robotic arms from Universal Robots are designed to meet the Pharma industry's specifications for accuracy, precision and hygiene. Robotics in the pharmaceutical Pharma Bio World
industry is performing a wide range of tasks: from packaging in medical devices and implants as well as assisting in surgeries. The robot arms from Universal Robots can be used for mixing, counting, dispensing and inspection to deliver consistent results for business-critical products. They can also be used for sterile handling and assembly of the small, delicate parts that are used in prosthetics, implants and medical devices. Three robotic arms from Universal Robots namely UR3, UR5 and UR10 can incorporated into the processes so that engineers could easily adapt the software to the specific needs of the drugs and the required tasks. The easy programming, installation and collaborative nature of the industrial robot arms allow them to work side-by-side with the workforce for efficient, high-quality medicines. Automation has been an indispensible part of the Indian manufacturing industry for decades now and has seen remarkable improvements in the efficiency and productivity of the industry. According to IBEF, the domestic Indian pharmaceutical industry was estimated to be USD 36 billion in 2016 growing at
nearly 20 per cent and is expected to reach nearly USD 55 billion in 2020. It is evident that a lot of internal factors are responsible for the growing Indian pharmaceutical industry. There are more than 200 companies' medicines for the largest population in the world which adds to the prevailing competition on the domestic front. The Indian Pharma industry is a success story in developing countries because within a span of three decades India has become one of the world's largest manufacturers of medicines. The past decade has seen a change
in the mindset of most pharmaceutical companies and a digital wave has swept the USD 36 billion Indian pharmaceutical Industry. The pharmaceuticals are now keen in adopting technology in every aspect of their operations. Thus, the incorporation of collaborative robots will be a timely introduction to revolutionize the Indian Pharma industry which will bring optimization of processes, reduce waste, improve yield in production, with higher efficiency and precision. The functions that have already embraced automation will continue to prevail with incremental improvements from the normal cycle of technological innovation. Areas that are likely to witness quantum leaps will be in the integration between development work and manufacturing, efficiency and optimum utilization of robotics in the industry.
Contact: janaki@mutualpr.com
Pharma Bio World
June 2019 â–ş 31
Product Packaging and Labeling In recent times, it has become quite straightforward to understand which attribute on the packaging the consumer will shell out more money. The packaging speaks for quality, safety of the food and environment. The increased awareness of environmental conservation and the escalating rate of foodborne illnesses have driven the food industry to implement a more innovative solution, i.e. bioactive packaging.
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ackaging material has evolved in past 20000 years. The usage of indigenous natural material such as hollow logs, leaves, shells, earthen pots were used to transport the food to smaller distances. Subsequently in 1950’s the use of metals, paper, heat shrinkable plastic came in existence. Plastic as a material has evolved with leaps and bounds to different texture of the packaging material. BPA (Bisphenol A) an industrial chemical used in certain plastic and resins since 1960’s. Substantial amount of scientific evidence show ill effects of BPA in human health. More manufacturers are producing and labelling BPA free products. If a product isn’t labeled BPA free, keep in mind that some, but not all, plastics marked with recycle codes 3 or 7 may be made with BPA. In this argument of BPA, India has forgotten another chemical phthalate that are used to increase the flexibility of plastic. Scientific evidences show the effect on reproductive system in the presence of phthalates. As per European and UK regulatory bodies, tolerable safety limits are put in place for presence of phthalates in food. Although the issue of phthalates in the form polyethylene terephthalate (PET) packaging was ignited in India in the year 2016, no substantial regulation has been put in place in this regard. The threats of few packaging technology to health has enforced large MNC’s like Coco Cola to go back to glass bottle packing from plastic bottles Innovative Packaging
Shruti Kumbla Senior Nutritionist Pristine Organics Pvt. Ltd 32 ◄ June 2019
Tetra Pak is one of the most efficacious innovation that keeps us amazed the
way it maintains the shelf life of the most perishable food item like milk. Unlike traditional inert packaging, active modified atmosphere packaging (MAP) has received a lot of focus in recent years. Active MAP packaging includes oxygen scavenging packaging, humidity-controlled packaging, antibacterial packaging and spontaneous modified atmosphere packaging. Intelligent food packaging is an upcoming technology which involves the ability to sense or measure an attribute of the product, the inner atmosphere of the package or the shipping environment. Intelligent packaging involves indicators, radio frequency identification tags (RFIT) and sensors. This helps in maintaining product food safety, quality and improves the efficiency of supply chain management. The bioplastic materials are more encouraging in the packaging industry when compared to the petrochemical based plastics. More awareness towards environment friendly issues, food packaging industry is constantly innovating new biodegradable materials. Starch based biodegradable packaging material are under research to make its application more feasible in the commercial market. A very interesting innovative research was conducted to produce photo-producible and photo-degradable starch bio-nanocomposite as a packaging material. Now we really know, environment safety has led to more innovation towards biodegradable packaging material which will pose less horrendous impact to the environment and health Pharma Bio World
Scientific research on the production, quality and potential applications of edible/biodegradable films in food manufacturing has been carried out by several research groups worldwide and has been reported in research publications. Edible films formed from whey protein concentrate, alginate, pectin, carrageenan is under trials for commercial purpose. Food Labelling Food labelling generally means putting information on food packaging, labels or collective packaging, which concerns the food packed. This information takes the form of words, letters, logos, images, figures or symbols and may refer to the shelf-life of the product, ways of preparation, consumption, nutritional value or other commercial aspects. The confusion between Best Before and Use by date still exists among the consumers. As per FSSAI, Best before means the date which signifies the end of the period under any stated storage conditions during which the food retains the specific qualities which have been claimed. Beyond the date, the food remains safe for consumption, though its quality may have diminished. Use by date or Expiry date means the date which signifies the end of the estimated period under any storage conditions, after which the food will not be safe for consumption.
made are the healthier option. The consumption of hidden sugar and salt have risen above the limits of WHO guidelines. This system will keep the consumer be more informed. Time temperature indicators gives information on the temperature and shows the variation and history in temperature, visualized as a color change. The commercial available brands are, Fresh Check, VITSAB, MonitorMask (3M). OnVuTM label is one of the temperature indicator. Radio frequency Identification Tags (RFIT) is a new revolutionary data information carrier in comparison to the existing bar code system. RFIT uses electromagnetic fields to automatically identify and track tags attached to objects. The tags contain electronically stored information. Passive tags collect energy from a nearby RFID reader ’s interrogating radio waves. Active tags have a local power source (such as a battery) and may operate hundreds of meters from the RFID reader. Unlike a barcode, the tag need not be within the line of sight of the reader, so it may be embedded in the tracked object. RFID is one method for Automatic Identification and Data Capture (AIDC).
Therefore, beside protective or transport functions, packaging must fulfil the information function, particularly in conditions of a limited involvement of sales staff in trade. Food packaging is an essential marketing tool, the importance of which is reflected both in the performed functions and the role in the process of making decision on purchase by consumers. It is worth remembering that the first contact of a consumer with a product occurs mostly through packaging. The characteristics of packaging often determine the interest in the product. The new innovative packaging helps in improving the food safety and quality. Labelling of products is crucial for ensuring security and reliable nutrition information for consumers. Due to the increasing awareness of the relationship between diet and health, it induces consumers to look for nutrition information and helps to make the right choices, while buying food products. Innovative color code labeling incorporated in the west is the new beginning towards making the consumer an informed buyer.
Conclusion Packaging was traditionally understood as a means of protecting a product in the process of distribution, transport or storage. However, currently, it is increasingly
Internationally, color code system is adopted in mentioning the nutrition information table. These color codes are specifically denoted for fats, saturated fats, sugar and salt. Red stands for high, amber means medium and green means low. This will allow the consumer to see at glance if the food choices Pharma Bio World
becoming an effective way to communicate with the environment. On the one hand, it is a consequence of development of various forms of self-service sales and on the other hand, of the growing consumer demand for information because of the growing nutritional awareness.
Contact: sunanda@pepperinteractive.in June 2019 â–ş 33
Pharma 4.0 – Impact of IIoT in Pharmaceutical Manufacturing
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ith the growing number of medical ailments across the globe, the pharmaceutical industry will undoubtedly become more important than ever in the near future. There is a paradigm shift from the mass production of drugs to offering more customized and specialized drugs to a smaller group of patients and this is greatly expected to improve the effectiveness of treatments. The Pharma 4.0 initiative is expected to not only address productivity issues but also provide the industry with smarter tools that can help ensure drug safety. Everyday factory equipment, people, and processes are thus getting increasingly smarter with the advent of digitization. The introduction of digitization in pharmaceutical manufacturing will also be instrumental in enabling a seamless data exchange across the pharmaceutical supply chain. The connectivity of product, people and process is what constitutes the Industrial Internet of Things (IIoT). Manufacturing will undoubtedly be the biggest beneficiary of IIoT. Thus, industries such as pharma and healthcare will certainly stand a good chance to continue to benefit from IIoT. Analyticsenabled data management vis-Ă -vis traditional paper-centric approaches will come a long way in being crucial enablers for important management decisions. The pharmaceutical industry should consider making investments in IIoT technologies, most of which are already mature in other industries and have proven effective in improving the efficiency of complex manufacturing operations. Leveraging lessons from this should help companies improve their financial and operational performances.
integrating the different manufacturing departments that are otherwise not adequately connected. IIoT technologies will enable manufacturers gain a 360-degree view of their plant operations with the ability to drill down to any level of detail at any stage of product development. This essentially would mean that data would be made available at just a tap of the screen. Manufacturing companies will transform from being small local hubs to global market places with the introduction of IIoT. The pharmaceutical industry has been among the forerunners in adopting these digital technologies that can help improve process efficiencies, reduce efforts, and increase profits. Within the industry there has always been an impetus to manage manufacturing processes more effectively. However, the pharmaceutical industry faces several challenges in being one of the most regulated manufacturing industries. The industry demands a good understanding of manufacturing processes and strict adherence to stringent regulatory standards that guide these processes. Due to regulatory
compliance issues in this sector, it has become mandatory for companies in the pharma industry to implement digital technologies. As is the case with any other industry, pharmaceutical manufacturing is faced with challenges, such as the need to enhance product quality, improve process efficiencies, reduce cycle times, reduce scrap and rework, track products, ensure adherence to regulatory guidelines, reduce downtime, and connect the supply chain among several others. This wall of challenges will however crumble eventually, thanks to the advancing benefits of digitization. With emerging benefits of industrial IoT and its increased applications in manufacturing, the dynamics of the industry is changing considerably. All information about machines, people, and materials involved in pharmaceutical manufacturing is required to be recorded according to mandatory requirements set down by government agencies such as the Food and Drug Administration (FDA). There is also an increasing demand for real-time reporting within the industry and IIoT plays a crucial role
Digital technologies have thus become a quintessential component of the manufacturing industry in automating operations, streamlining processes, and
34 â—„ June 2019
Pharma Bio World
in making the requisite data available. Connectivity ensures management and monitoring of manufacturing operations on the factory floor. Digital initiatives can by large provide a strong foundation for initiatives, such as Industry 4.0 to take over factory management. Manufacturers will be required to constantly upgrade their digital systems until such time when Industry 4.0 can be implemented in a fullfledged manner. Factory machines may already be connected and controlled by systems such as Supervisory Control and Data Acquisition (SCADA) or Manufacturing Execution Systems (MES) or even Distributed Control systems (DCS). Industrial IoT is an added perk that brings along with it the power of data and computational prowess. This could now imply bringing in the power of analytics to generate valuable insights that can help oversee plant workflows and track and maintain machine activities much ahead of a breakdown. The benefits of IIoT in pharma manufacturing will pretty much be the same as is the case with several other industry verticals. The Pharma Bio World
distinguishing advantage, however, could be in the fact that IIoT can go a long way in helping pharma manufacturers ensure a proper documentation during production for compliance reasons. Industry 4.0 could also help steer the pharma industry towards a paperless environment with lesser human intervention involved. This could involve terabytes of data being stored and processed on the cloud, as traditional methods of data storage get completely phased out. Introduction of IIoT in pharma would also mean making a fundamental shift towards outcome-based targeted therapies characterised by a more individualized production method.
Pharma is also an industry that has extremely sensitive storage conditions. The manufactured products typically are of high value and have a short storage life. They also mostly need to be stored under prescribed storage temperatures, which cannot be monitored if not for critical components of IIoT such as sensors and connectivity. IIoT has become an integral part of manufacturing and therefore it is only natural that the pharma industry should look to adopting it at the earliest. This would involve manufacturing companies taking important decisions such as phasing out legacy systems and transforming business models.
IIoT plays an important role in the continuous monitoring of connected factory equipment and personnel. This real-time tracking of equipment can help improve effectiveness of factory processes by enabling informed decisions through data resultant of connectivity. The other important benefit of IIoT in pharma manufacturing is the modular automation of pharma production plants, which enables a faster time-to-market for pharma products.
The IIoT may be at its nascent stages of development, but its impact on pharmaceutical manufacturing is certainly indisputable. Only those market participants able to see the potential gains and start taking those small baby steps will be the ones who will eventually be able to reap benefits from IIoT.
Article courtesy: Frost & Sullivan June 2019 â–ş 35
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marketing initiatives
Mass Flow Controlled Coating of Medical Devices
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dvances in the design of medical devices such as catheters, guide wires and stents have greatly improved the quality of medical care. However, these devices are often made with materials that bring undesirable complications, such as bacterial infection, blood clots, and tissue trauma caused by device insertion. It is common to apply specialist coatings to alleviate these difficulties.
Coatings must be applied in a repeatable verifiable manner especially when the coating is an active drug product as for example in the case of a drug eluting stent. Traditional coating technology involves the spraying of liquids using various types of nozzles, in all these applications the control of flow is vital to the accuracy of the coating applied. By using traditional flow metering and pump control techniques flow-rates can be controlled to 5-10 Per cent of the target rate. This may be acceptable in some applications, however where active drug substances are being applied a variation of 10 Per cent in drug coating leads to an unacceptable rate of failures & losses at the QC stage. Responding to the need to improve flow control technology in low flow coating
applications we have developed a unique mini CORI-FLOWTM controlled pumping system which uses the Coriolis principle to accurately measure true mass flow rate. Flow rates as low as 0.2 grams/hour can be controlled to an accuracy of 0.5 Per cent of target The mini CORI-FLOWTM controller uses its integral fast PID control system to adjust the speed of a closed loop coupled pump resulting in a typical dosing accuracy of 0.5-1Per cent. This represents a 10 fold improvement in what is achievable using a traditional volume flow metering system. Some applications where this technology can be of benefit include: • Cardiac, peripheral and arterial stent coatings. • Drug eluting balloon coatings. • Pacemaker coatings. • Coatings onto sutures and surgical instruments. • Orthopaedic implant coatings. • Bio-absorbable coatings.
and
biocompatible
• Microencapsulation of pharmaceuticals. • Pharmaceutical spray drying. • Coatings for diagnostic test kits. • Protein, enzyme, and reagent coatings. • Supercritical CO 2 for creating drugloaded nanophase material. This measures mass flow directly and there is no need for the system to be calibrated for each liquid being pumped. It is not susceptible to errors caused by variations in density or temperature and is capable of controlling the flow of volatile fluids with low boiling points. The system is configurable to your individual needs and is available with a wide variety of pumps, communication, and control options.
• Hydrophilic or hydrophobic coatings onto medical devices such as catheters. • Guide wire coatings. • Heparin and silicon coatings for blood collection tubes and syringes. • Silver Silane coating onto bandages. • Anti-microbial coatings onto medical textiles such as bandages, surgical gauze, gloves and masks. 38 ◄ June 2019
For details contact: Toshniwal Hyvac Pvt Ltd 267,kilpauk Garden Road Chennai - 600010 Tel : + 91 44 26445626 /8983 E-mail : sales@toshniwal.net Website : www.toshniwal.net Pharma Bio World
marketing initiatives
TOSHNIWAL DIRECT DRIVE PUMPS
O
ver three decades of expertise in vacuum technology, we offer customized solutions ranging from individual products to a complete
system.Toshniwal‘s Direct Drive high Vacuum Pumps, the 72 - D series double stage model is with ultimate vacuum. These vacuum pumps are compact, since they are directly mounted on motor flange.These pumps have pumping speeds and high water vapour tolerance.The Oil consumption is extremely low and air cooled. 72 - D series pump offers improvement in the areas of quieter operation, smaller size, and easy maintenance.
HYDROSYS - (Liquid Ring Vacuum Pump)
Range : 120 l - 1000 l / min • Portable • Highly reliable • Low noise operation • Double Stage pumps • Compact and sturdy design • Advanced lubricating system • Easy maintenance and usage
For details contact: Toshniwal Instruments(Madras) Pvt Ltd 267,Kilpauk Garden Road Chennai - 600010 Tel: +91 4426445626 / 8983 E-mail: sales@toshniwal.net Web: www.toshniwal.net
O
ur vast experience coupled to the countless installations we have in the field, allows us to offer any type of “turn key” packages to meet the customer’s needs. Pump system type HYDROSYS include liquid ring vacuum pump, cyclone type air-liquid separator,heat exchanger and associated accessories all mounted on a fabricated frame.
For details contact: Toshniwal Instruments (Madras) Pvt. Ltd. 267 Kilpauk Garden Road, Chennai - 600 010. India Tel: +91 44 26448983 / 8558 Fax: +91 44 26441820 E-mail: sales@toshniwal.net Web : www.toshniwal.net Pharma Bio World
June 2019 ► 39
marketing initiatives
Level indicators
V
isual level indicators combine up to three functions in one instrument: Level indicator, level switch and level transmitter. The display that can be read even over large distances works without energy and automatically as a result of the physical law of liquids in communicating v e s s e l s . The WEKA visual level indicators are characterized by their compact design and the wide range of applications. W i d e application range Operating pressures can range from a vacuum up to 500 bar as well as calculation pressures for the float standpipe up to the nominal pressure PN 630. Liquid densities > 0.27 g/cm3 as well
as a temperature range from 77 K to 673 K (-196 °C to 400 °C) allow use in applications for cryogenic liquid gases as well as in water hydraulics and steam boilers. Hermetically sealed floats for condensing media are available up to a max. operating pressure of 320 bar. Flexibility through choice of suitable materials • Standard materials: 316/316L 1.4435/1.4404, group A4 stainless austenitic steel. • Other possible stainless austenitic steels: 304/304L 1.4301/1.4306, 1.4571, 321, 1.4541. Energy-free, automatic operation The WEKA visual level indicator is ideal for the commissioning of systems. The display works without energy and automatically as a result of the physical law of liquids in communicating vessels. Independent of a controller - and thus also independent in the event of a power supply failure - visual level indication on site is ensured. Excellent readability The wide, red- and silver-colored flag indicator system is easily and clearly readable, even from over large distances. The fully transparent flag indicator system made of polycarbonate (PC) also ensures
readability from the side. The liquids, which are not always unproblematic and sometimes also hazardous, are safely enclosed in the dense and pressure-tight float standpipe and separated from the indicator. Level measurement As described, WEKA visual level indicators offer the ideal solution for almost all operating conditions. For most applications, you will find a suitable device from our standard program. Again and again, however, customized solutions are also required for special operating conditions. Many designs can, for example, also be used in hazardous areas according to ATEX or IECEx. (ATEX is a widely used synonym for the ATEX guidelines of the european union.) The designation ATEX is derived from the french abbreviation for atmosphere explosibles. Our instruments can thus also be used in potentially explosive atmospheres. For details contact: Toshniwal Hyvac Pvt Ltd 267,kilpauk Garden Road Chennai - 600010 Tel : + 91 44 26445626 /8983 E-mail : sales@toshniwal.net Website : www.toshniwal.net
MASS FLOW CONTROLLER
T
he mass flow meters and controllers consist of a metal body with a straight throughflow path. Two sensors are encased with stainless steel and protrude inside this bore; one is designed as a heater and the other one is designed as a temperature probe. The working principle is based on King’s law of
40 ◄ June 2019
the ratio between the mass flow and the heater energy. That means the higher the flow, the more energy is required to maintain the chosen. Features • Direct inline measurement principle • Usable for virtually every kind of gas or gas-mix • Mass flow measurement and control for a wide scope of applications • Compact and robust design • IP65 for full product range • Sensor made of stainless steel
• No inlet pipe required • Measurement without moving parts • Customised adjustable multifunctional display: actual flow, totaliser with memory and reset,alarm, setup and much more. For details contact: Toshniwal Hyvac Pvt. Ltd. 267 Kilpauk Garden Road, Chennai 600 010. Tel: 044 - 2644 8558 / 8983 Fax: 044 - 2644 1820 E-mail : sales@toshniwal.net Web site : www.toshniwal.net
Pharma Bio World
press release Novartis India Limited reconstituted Board; appointed Mr. Sanjay Murdeshwar as Vice Chairman & Managing Director Mumbai, India: At a recent meeting held in Mumbai, the Board of Directors of Novartis India Limited announced the appointment of Mr. Sanjay Murdeshwar as Vice Chairman & Managing Director with effect from June 15, 2019. Mr. Sanjay Murdeshwar is the Country President, Novartis in India and also responsible for the pharmaceuticals business in the country. He is also the Managing Director of Novartis Healthcare Private Limited. Mr. Murdeshwar comes with more than 20 years of experience in the healthcare industry which includes varied roles in the pharmaceuticals and consumer health businesses. Before joining Novartis, he was with AstraZeneca based in Maryland, USA as Vice-President in their Global Product & Portfolio Strategy group prior to which he held various general management roles with AstraZeneca. Prior to joining AstraZeneca, Mr. Murdeshwar was with Bayer AG with stints in various roles based in both developed and emerging markets. Mr. Murdeshwar has a Bachelors' Degree in Chemical Engineering and an MBA.
Torrent Pharmaceuticals Ltd. | Q4FY19 Result Update | Earnings impacted by US sales | Overall outlook remains positive Ahmedabad, Gujarat: Torrent Pharma reported Q4 results in line with he estimates, except net loss due to products recalls (Glosartan) and an exceptional expense of ` 3.6 bn incurred in relation to the impairment of intangible assets in the Bio-Pharma business in the US. The management has discontinued the sale of Glosartan in the US from Q4FY19 onwards. It is therefore forecasted to impact FY20 revenue growth as Torrent has a strong market share in the US. Further, there may be delays in product approvals due to the recent inspection at Dahej and Indrad plants, for which F-483 is pending. The company has slightly tweaked their EPS estimates of FY20 and FY21 to ` 48.3 and ` 61.6 respectively (vs ` 62.7 and ` 78.5) based on the Pharma Bio World
slowdown in the US business. However, the Company is positive on the future outlook based on the strong domestic portfolio, which will grow faster than the IPM in the coming quarters on a sequential basis. Torrent is valued at 16x FY21 EV/EBITDA as near-term earnings are likely to be suppressed owing to the Unichem acquisition (which is affected by high amortization charges), with a revised target price of ` 2006 (previously ` 2001 on 16x FY21 EV/EBITDA). Reiterate BUY. Q4FY19 result snapshot: Torrent’s Q4FY19 revenues grew 8 percent YoY to ` 18 bn (in line with the estimates) largely impacted by the US business, and the gross margin came in at 71 percent (in line with the estimates). This led to a 14 percent YoY increase in EBITDA owing to an increase of 144 bps in Q4FY19 (in line with the estimates). The company reported a net loss of ` 1.5 bn in Q4FY19 (below the estimate of ` 2.2bn) due to an exceptional expense of `3.6 bn, resulting in negative EPS of ` 9. Other divisions include the US (up 21 percent YoY at USD 53.4 mn), Brazil (down 5 percent YoY), and other Europe (up 3 percent YoY). Valuation: Our analysis suggests that growth will be largely driven by branded revenues in India, moderate growth in Brazil, and superior growth in Europe. We expect FY20 to be a moderate year for Torrent, with sustainable EBITDA margin improvement in the Unichem portfolio resulting in an improvement of at least 100bps YoY in the overall operating margin. At the CMP, Torrent is trading at 14.5x FY21 EV/ EBITDA. Reiterate BUY.
Glenmark Pharmaceuticals received ANDA approval for Solifenacin Succinate Tablets Mumbai, India: Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Solifenacin Succinate Tablets, 5 mg and 10 mg, a generic version of Vesicare Tablets, 5 mg and 10 mg, of Astellas Pharma US, Inc. According to IQVIA sales data for the 12 month period ending March 2019, the Vesicare Tablets, 5 mg and 10 mg market achieved annual sales of approximately USD 942.7 million*. Glenmark’s current portfolio consists of 154 products authorized for distribution in the US marketplace and 58 ANDA’s pending approval with the USFDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio. *IQVIA National Sales Perspectives: Retail & Non-Retail, March 2019 June 2019 ► 41
press release Sygnature Discovery and RenaSci strengthen in vivo pharmacology service-offering
(L to R): Dr Paul Clewlow, Senior VP, Business Development of Sygnature Discovery; Dr Nick Moore, Senior Director, Business Development of Sygnature Discovery; Dr Sharon Cheetham, Executive Director of RenaSci.
Nottingham, UK: Sygnature Discovery, a leading drug discovery and pre-clinical services company, have appointed Dr Nick Moore as Senior Director, Business Development, in a newly-created role to promote the in vivo pharmacology and consultancy services offered by RenaSci, a wholly-owned subsidiary company. Dr Moore is an internationally recognised drug discovery and development specialist who has spent nearly 40 years working in the field of in vivo pharmacology. Previous roles include research appointments at Eli Lilly, Lundbeck Research USA, and Albany Molecular Research Inc. (AMRI), and business development positions at Brains On-Line and Charles River Laboratories. He earned his PhD in neuropharmacology from the University of Birmingham and career highlights include a key involvement in the development of Lilly’s antipsychotic drug Zyprexa (olanzapine). One of Dr Moore’s key tasks will be to ensure that the synergistic in vitro and in vivo services and drug discovery expertise offered by Sygnature Discovery and RenaSci are maximised for the benefit of clients. “I plan to focus on growing the in vivo pharmacology business and ensure that both current and new customers are aware of the expanded service-offering that the wider Sygnature Group is now able to provide”, Dr Moore said. “Nick is a very experienced drug discovery scientist who brings a huge amount of in vivo pharmacology know-how and proficiency into the business," said Dr Paul Clewlow, Sygnature Discovery’s Senior Vice President, Business Development and a member of the Board at Sygnature and RenaSci. “I am pleased that Nick has joined my team as he will work closely with colleagues at RenaSci and Sygnature to convey the enhanced capabilities and expertise we offer to clients and identify new in vivo pharmacology capabilities that will complement and augment our current integrated offering.” 42 ◄ June 2019
RenaSci, founded in 2001, became part of the Sygnature Group in July 2018 following several successful project collaborations with joint clients. Sygnature and RenaSci were amongst the first companies to be established at BioCity Nottingham, the R&D site where Boots Pharmaceuticals discovered ibuprofen. The strategic acquisition of RenaSci by Sygnature stemmed from a long-standing mutual respect between the organisations and the firm belief by Sygnature that combining the two companies would be beneficial not only to their customers, but ultimately to patients with considerable unmet medical need in abuse and dependence, CNS disorders, obesity, diabetes, NASH and kidney disease. “We realised that RenaSci and Sygnature Discovery were highlycomplementary businesses because we have a strong shared focus on high-quality science and delivering new and efficacious drugs to patients,” said Dr Sharon Cheetham, Assistant Professor and Executive Director at RenaSci. “I am delighted to welcome Nick to the Group and we look forward to working with him to expand our business and better serve our clients in the drug discovery and pre-clinical sector."
Transasia Bio-Medicals in ` 50 crore expansion of its Sikkim manufacturing plant New Delhi, India: Transasia Bio-Medicals Ltd., India’s leading in-vitro diagnostics company, has announced a ` 50 crore investment in the expansion of its manufacturing facility in Sikkim. The largest of its India manufacturing plants, Sikkim is the fourth one after Mumbai, Daman, and Baddi. Also, the first ever diagnostics manufacturing facility in Northeast, the expanded facility will significantly enhance Transasia’s capacity to cater to the growing Indian and overseas market demands. Spread over 2 acres, the state of the art facility can produce 6000+ instruments monthly including the complete range of semi-automated analyzers. Announcing the new facility, Suresh Vazirani, Chairman & Managing Director, Transasia Bio-Medicals Ltd., said, “Sikkim is fast becoming a major hub for healthcare manufacturing with 14 major players already there. Transasia’s new facility will further reinforce this besides providing employment to local youth who otherwise would need to move out of the state for such quality opportunities. With this addition of capacity, we are well placed to deliver to the demand arising from continued growth posted by the company both in Indian and overseas markets.” Limited access to quality medical infrastructure, including skilled manpower and technologies have been the pain points of over 70 Percent of Indians who live in smaller towns and rural areas. Transasia addresses this through its competitive pricing, which makes diagnostics affordable besides having a sales & service network present nationwide. ‘Transasia on the Move’, a first in the Indian IVD Industry, is a specially designed mobile lounge to demonstrate its products and technology at the door steps of healthcare professionals in towns and small villages across India. 2500+ clinicians have viewed cutting edge technologies in a short span of 60 days. Pharma Bio World
press release India Alternatives invested in Brinton Pharmaceuticals Pune, India: India Alternatives Investment Advisors Ltd. invested up to USD 8 million for a significant minority stake in Brinton Pharmaceuticals Limited. Among the fastest growing companies in the Indian pharmaceutical market, Brinton is focused on dermatology and has recently expanded into the paediatric dermatology & respiratory segments. Speaking on the occasion, Mr. Rahulkumar Darda, Chairman & Managing Director, Brinton Pharmaceuticals said, “We are excited to partner with an investor of the calibre of India Alternatives and strongly believe this association will bring synergies and help us continue our profitable growth journey. This investment will enhance our capabilities in formulations and Research & Development for niche areas of dermatology and cosmetology and support expansion of the company’s footprint within India as well as globally.” Mr. Vijey Christopher J, Director, Brinton Pharmaceuticals added “In a short span of time Brinton has made its presence felt both in dermatology and paediatrics through our innovative high quality products stemming from world-class R&D units across the globe. We are aiming for a leadership position in our represented product markets and have a strategic road-map to achieve several milestones in the coming years.” Commenting on the investment, Ms. Shivani Bhasin Sachdeva, Founder & CEO, India Alternatives said, “India Alternatives’ investment in Brinton reflects its recognition of the Company’s solid management team, differentiated brands and focus on niche therapeutic segments. The investment in Brinton fits very well with two of our themes of women oriented consumption and health & wellness. We are excited to partner with Rahul and his team to support them through the next leg of their journey.” This transaction marks the second investment in Brinton by an institutional investor, following Tata Capital Healthcare Fund’s investment in 2017. Equirus Capital Private Limited acted as exclusive financial advisor to Brinton Pharmaceuticals, PDS Legal and Transaction Square acted as legal and tax advisors respectively to Brinton Pharmaceuticals. DSK Legal acted as legal advisors to India Alternatives.
Dr. Reddy’s Laboratories SA, announced positive topline results for patients with plaque psoriasis Hyderabad, India: Dr. Reddy’s Laboratories Ltd. announced positive topline results from its Phase 2b study of PPC-06 (formerly referred to as XP23829) in patients with moderate to severe plaque Pharma Bio World
psoriasis. In the study, PPC-06 met both co-primary endpoints i.e. PASI-75 and IGA scores of 0 or 1 with at least a 2-point reduction from baseline, after 24 weeks of oral treatment. The detailed safety and efficacy data from the study will be presented in future dermatology conferences. “PPC-06 is an oral molecule with a novel mechanism of action that has the potential to address unmet medical needs of psoriasis patients. The topline data we are reporting support our belief that PPC-06 may become the first approved oral prodrug of Monomethyl Fumarate (MMF) for treatment of moderate to severe plaque psoriasis in the US. Further clinical development requirements will be discussed with the US FDA to support the approval of this product”, said Anil Namboodiripad PhD., Senior Vice President and Head, Proprietary Products Business. PPC-06 is an extended release formulation of a fumaric acid ester (FAE), in-licensed from Xenoport, Inc. for further development to treat moderate to severe plaque psoriasis. A Phase 2b clinical study was conducted to evaluate the tolerability, safety and efficacy of three doses of PPC-06 over 24 weeks. This was a randomized, double blind, placebo-controlled, dose-finding multicenter efficacy and safety study conducted at 76 sites in the US. Patients had stable, moderate to severe plaque psoriasis for at least 6 months, with PASI (Psoriasis Area and Severity Index) scores ≥12, IGA (5-point Investigator’s Global Assessment) scores ≥3, and psoriasis lesions involving 10 percent or more of the patient’s Body Surface Area (BSA) at study baseline. A total of 426 patients were randomized in a 1:1:1:1 ratio into 4 treatment arms: 400 mg QD, 400 mg BID, 600 mg BID, and placebo. The co-primary end points of the study were PASI-75 (i.e. proportion of treated subjects achieving a 75 percent reduction in their PASI score over baseline) and IGA score of 0 or1 at week 24. At week 24 analysis, PASI-75 was achieved by 44.3 percent, 47.2 percent, and 39.7 percent patients in PPC-06 600 mg BID, 400 mg BID and 400 mg QD treatment groups respectively, against 20 percent of patients in the placebo group (p<0.05). Additionally 44.4 percent, 41.4 percent and 35.7 percent of patients in the PPC 06 600 mg BID and 400 mg BID and 400 mg QD groups, respectively, achieved an IGA score of 0 or 1(IGA Clear) at week 24 against 22 percent of patients in the placebo group (p<0.05). The most common adverse events (AE’s) reported were lymphocytopenia, eosinophilia and gastro-intestinal (GI) disorders, such as diarrhea, nausea, abdominal pain, and vomiting. “Given the positive clinical data in this study, PPC-06 may have a potential to serve as an important therapeutic option for psoriasis patients in a market with limited oral treatments. We thank all the patients, investigators, and study staff whose ongoing participation helped us achieve this target.” said Sagar Munjal, MD, MS, Chief Medical Officer Promius Pharma/VP Clinical Development & Medical Affairs. June 2019 ► 43
press release Phoenix Molecular Designs and WuXi STA Cadila Healthcare Ltd. | Q4FY19 Reach Drug Supply Milestone to Support Result Update | Q4 results in line with Phase I/Ib Study of PMD-026 for TNBC estimates | Muted FY20 outlook Vancouver, British Columbia, and San Diego: Phoenix Molecular Designs (PhoenixMD), a privately-held biotechnology company designing precise cancer therapeutics targeting essential kinases, has announced the completion of clinical trial supply manufacture for PMD-026. PhoenixMD's lead program, PMD-026, is the first RSK inhibitor built for the treatment of triple-negative breast cancer (TNBC). The clinical trial supply was undertaken by STA Pharmaceutical (WuXi STA), a subsidiary of WuXi AppTec, and is being used to support IND-enabling toxicology studies and an upcoming Phase I/Ib study in women with breast cancer. In March 2018, the companies entered into a major manufacturing agreement, and have since produced a multi kilogram drug supply for PMD-026 under GMP manufacturing practices. This represents a significant milestone, accelerating PhoenixMD's Phase I readiness. In order to further the collaboration, WuXi STA expanded its USA operations to include capsule production under GMP regulatory compliance. Dr. Minzhang Chen, CEO of WuXi STA, commented "The opportunity to enable PhoenixMD's first-in-man studies came at an opportune moment for STA's San Diego facility." "Our partnership with WuXi STA has been critical for PhoenixMD to advance this stage of our development. Working with such a high quality, globally recognized manufacturing partner has allowed us to rapidly advance PMD-026 through IND-enabling GLP toxicology studies and has enabled us to be ready to initiate our Phase I/Ib study with high quality API in capsules," said Sandra E. Dunn, CEO of PhoenixMD. "The rapid achievement of this milestone brings us one step closer to initiating our study for women suffering from breast cancer. More specifically, metastatic triple-negative breast cancer, which is the most deadly type of breast cancer. RSK2 is a promising new drug target for the treatment of TNBC, and PMD-026 is the first drug to ever reach clinical use against this novel target." "The secret sauce in our success is teamwork. We truly appreciate the collaborative approach and commitment that WuXi STA has brought to the PMD-026 project," notes Dr. Dunn. The drug supply is sufficient to treat all of the patients in the Phase 1 study. This is coupled with the completion of PhoenixMD's CDx for measuring activated RSK2 in tumors signals, enabling the two key elements needed for this precisely designed clinical trial to advance. 44 â&#x2014;&#x201E; June 2019
Ahmedabad, Gujarat: Cadila reported Q4 results in line with our estimates, with a revenue of ` 36 bn (up 15 percent YoY), largely driven by the wellness business (which benefitted from the Heinz acquisition). Growth in the US stood at ` 17.9 bn (up 9 percent YoY), enhanced by Androgel AG supplies, along with certain launches, and a stable base business. The management expects the US base business to sustain in FY20 with more than 30 new product launches. India business was muted at ` 9 bn (up 2 percent YoY). In Europe, revenue was ` 535 mn (down 11 percent YoY), whereas the emerging markets (including LATAM) reported healthy sales of ` 2 bn (up 63 percent YoY). The management believes that the strong US pipeline will support its US generics business, and there is a lot of scope to improve cost rationalization. FY20 onwards, the next growth driver in the US will be the specialty business. The company is restructuring its domestic business by focusing more on therapies like CVS, gastro, and respiratory. It also expects MR efficiency to increase from the next quarter and expects growth of 8-10 percent in FY20. We believe EBITDA margin to be stable at ~23 percent in FY20 & 21 based on stable growth in the US and India business. We are cutting our revenue and EPS estimates of FY20 & 21 by ~2 percent and ~10 percent respectively, and considering the recent fall in the stock price by 20 percent, we are reducing our TP to ` 348 at 18xFY21 EPS of ` 19.2 (earlier TP of ` 433 at 20XFY21 EPS of ` 21.7). At the CMP, the stock trades at 15xFY20 EPS of ` 18.1. Reaffirm BUY. Q4FY19 result snapshot: Cadila reported Q4 results in line with their estimates, as sales came in line at ` 36.1bn (up 14 percent YoY against the estimate of ` 35.4 bn). Sales were largely driven by the wellness business, boosted by the Heinz acquisition (which contributed 7 percent to Q4 sales growth) and US sales of USD 256 mn. Gross margin stood at 61.7 percent, declining 400 bps YoY. EBITDA for the quarter was ` 8 bn (our estimate was ` 7.9 bn) owing to the margin of 21.4 percent. There was sharp increase in the interest cost at ` 773 mn in Q4 as against ` 154 mn in the corresponding period of last year. PAT came in at ` 4.6 bn (our estimate was ` 4.4 bn). Outlook: FY20 will be a challenging year for Cadila owing to the expected price erosion in Glialda and Tamiflu sales. Despite the pending regulatory hurdles on the Moraiya facility, the management guidance indicates the launch of over 35 products in the US (excluding Moraiya launches and approvals) and higher growth in the domestic business. We are cutting our revenue and EPS estimates of FY20 & 21 by ~2 percent and ~10 percent respectively, and considering the recent fall in the stock price by 20 percent, we are reducing our TP to ` 348 at 18xFY21 EPS of `19.2 (earlier TP of ` 433 at 20XFY21 EPS of ` 21.7). At the CMP, the stock trades at 15x FY20 EPS of `18.1. Reaffirm BUY. Pharma Bio World
press release SCHOTT repeatedly increases production capacity for pharmaceutical tubing in India
SCHOTT is investing in a new tank facility at its site in Jambusar, Gujarat, following an expansion last year. Image: SCHOTT
Mainz, Germany and Jambusar, India: The German technology group SCHOTT is investing an additional double-digit million-euro figure into a new glass tank at its tubing manufacturing plant in Jambusar, Gujarat. The expansion follows recent investments at the site including the construction of another additional tank facility just last year. Production of pharmaceutical FIOLAX tubing from the new tank is scheduled to begin in the second half of 2020. The capacity expansion is part of the company’s global growth strategy of its pharma tubing and packaging business segments. “The pharmaceutical market is booming worldwide with a very high demand for premium pharmaceutical packaging and tubing”, commented Dr. Patrick Markschlaeger, Executive Vice President at SCHOTT, Business Unit Tubing. “In order to supply the rapidly growing domestic and Asian market, we are investing once again a multimillion-euro figure in our Jambusar site to increase our manufacturing capacity in India.” FIOLAX borosilicate glass tubing features a high hydrolytic resistance, which makes it an ideal material for primary packaging of medicines. “Since its development in 1911, FIOLAX has been established as the gold-standard material for pharmaceutical containers and its behavior with drugs is well researched and proven. In India, it is primarily used to manufacture glass vials and ampoules”, added Sundeep Prabhu, Vice President Sales & Marketing, Jambusar at SCHOTT Glass India Pvt. Ltd. In line with the company’s aim to manufacture zero defect tubing, the tank will feature the unique big data approach perfexion. The process, which has been rolled-out globally by SCHOTT since 2017, ensured 100 Percent quality control of each tube on the line by using cameras, laser, and IR inspection systems. “In Jambusar we are combining Indian and European technologies and local skills. With the additional tank, we are also adding new workplaces,” explained Georg Sparschuh, Managing Director at SCHOTT Glass India Pvt. India. The new tank will be built and equipped with the latest state-of-the art machinery according to the high standard of all SCHOTT Tubing production sites. Besides the tank facility, the investment includes an extension of the batch house, warehouses and a new chimney.
Indoco Remedies Ltd. | Q4FY19 Result Update | Q4 results above estimate | outlook remains cautious Pharma Bio World
Mumbai India: Indoco posted its Q4 results above their estimate, except for net sales, which were down by 5.4 percent YoY at ` 2, 480mn (vs estimate of ` 2, 615mn). On a sequential basis, we see growth in the export formulation business, up 3.2 percent QoQ to ` 707mn. The API business posted a healthy growth of 62 percent YoY, boosted by the commercialization of the new facility at Patalganga. Although Unit I at Goa is currently under restricted import alert, the re-inspection by UK MHRA concluded with no critical observations. As per the management, Unit I should get clearance in the near future and the company can resume supplies to Europe. Due to the import alert, the regulated market sales have been impacted, declining by 40 percent YoY. The Indian business will be hampered by the inventory reduction. This was evident in the domestic sales, which was declined by 4 percent YoY. However, the management remained confident of a revival by early H1FY20. We remained cautious on the competitiveness of its product pipeline. We expect sales to register a 13 percent CAGR over FY19–21, with EBITDA margin to compress to 13 percent in FY20 and recover to 16 percent in FY21 until the capacity utilization for exports plays out. At the CMP, the stock trades at 21.4x FY21 EPS of ` 8.8. Maintain REDUCE with a revised target price of ` 158. Q4FY19 result snapshot: Indoco posted Q4 results above expectations, except for net sales, which were down by 5.4 percent YoY at ` 2,480mn (vs estimate of ` 2,615mn). EBITDA for the quarter came at ` 286 mn, down 42 percent YoY (up 15 percent QoQ) owing to the margin of 11.3 percent. The improvement in EBITDA margin was due to contribution of exports. PAT for the quarter stood at ` 116mn, down 43 percent YoY (above our estimate of ` 22 mn), owing to the decline in other expenses and rise in other income and deferred tax assets of ` 22 mn during the quarter.
Dr. Reddy's Laboratories announced the relaunch of Zenatane (Isotretinoin Capsules, USP) in USA
Hyderabad, India and Princeton, NJ, USA: Dr. Reddy’s Laboratories Ltd. has announced the re-launch of Zenatane (Isotretinoin Capsules, USP), 10 mg, 20 mg, 30 mg, and 40 mg a therapeutic equivalent generic version of Accutane, approved by the US Food and Drug Administration (USFDA). The product is being launched with an approved Risk Evaluation and Mitigation Strategy (REMS) Program. “We’re pleased to bring this important product back to market for the customers and patients who will benefit from access to this medicine and who have had witnessed limited supply and options in the market place,” explains Marc Kikuchi, Chief Executive Officer, North America Generics. “Furthermore, this is important for our company as we have commercialized the first Softgel dosage product from Dr Reddy’s own manufacturing plant to ensure consistent and robust supply for this product in the US market.” The Zenatane (Isotretinoin Capsules, USP), 10 mg, 20 mg, 30 mg, and 40 mg brand and generic had US sales of approximately USD 525 million MAT for the most recent twelve months ending in March 2019 according to IQVIA Health*. Dr. Reddy’s Zenatane (Isotretinoin Capsules, USP) are available in 3x10 (30-count) blister packages of 10 mg, 20 mg, 30 mg, and 40 mg Capsules, USP. June 2019 ► 45
press release Abbott India Ltd. | Q4FY19 Result Update Mumbai India: Abbott’s top brands are growing faster than the market, due to which the company’s growth momentum has been accelerated. Besides that, new launches in the past two years and that too in the high-margin vaccine segment (through tie-up with Bharat Biotech), are likely to improve operating leverage. The inclusion of Claribid (product from merger at the parent level) in the listed entity should also boost growth. Despite regulatory challenges like NLEM, FDC ban, and generic draft policy as well as competitive pressures, Abbott India has been able to grow its business at 10 percent in H1FY19 vs. 9 percent industry growth, on the back of strong brand franchise and entry into new growth categories like vaccines and hepatitis. Its leading brands grew 18 percent vs IPM growth of 9 percent over FY16–18. There is a clear focus on growth and this is expected to drive earnings, along with a steady improvement in EBITDA margin. While insulin is primarily a distribution business for Novo Nordisk brands, its share has been reducing gradually over the past few years. We expect Abbott to continue growing faster than the industry, led by strong new launches and superior marketing skills. Q4FY19 result snapshot: Abbott reported Q4 result came below estimates. Sales grew 15 percent YoY to ` 9 bn (against est: ` 9.1 bn), driven by volume growth in major brands such as Thyronorm, Udiliv, and Duphaston. A favorable product mix aided gross margins at 44.4 percent (against est: ` 43 percent). Gross margins fell 85 bps due to a change in product mix. However, employee expenses and other expenses fell 420 bps due to productivity enhancement and efficiencies. EBITDA margin for the quarter stood at 16.9 percent owing to 334 bps YoY (up 141bps QoQ). PAT for the quarter came in at ` 1.1 bn up 13 percent YoY (against est: ` 1.2bn). EPS for Q4 came at ` 53. Valuation: We expect a 17 percent revenue and 18 percent PAT CAGR in FY19–21, primarily driven by: the revitalization of heritage brands and the primary healthcare business (top 15 brands contribute 50 percent to revenue and anticipated to record 14 percent CAGR, while Novo Nordisk segment would register 18 percent CAGR over FY18–20); acceleration in the specialty business; new product introductions; and the differentiated approach with doctors and patient engagement initiatives. Among MNCs, the stock is available at an attractive valuation of 30.7x FY20 EPS of ` 262. Given the continued strong performance, healthy return ratios, and strong FCF/EBITDA, we rate Abbott as one of the best companies amongst MNC peers. Maintain ACCUMULATE.
Fermenta Biotech Ltd.’s Dahej Facility De-bottlenecking Completed Dahej, Gujarat: Further to the disclosure regarding the major maintenance shutdown and de-bottlenecking programme at Dahej facility of the Company’s subsidiary, Fermenta Biotech Ltd has announced the completion of the maintenance work as well as the de-bottlenecking programme. The plant had undergone a 46 ◄ June 2019
routine shutdown for repairs and maintenance along with a debottlenecking programme for capacity expansion. With effect from 29th May 2019, the facility is back to operating at full capacities, which has been increased by about 15 percent as a result of the de-bottlenecking programme. Commenting on the development, Mr. Prashant Nagre, CEO, Fermenta Biotech Limited said : “The de-bottlenecking programme was a part of the capacity expansion measures that we are undertaking in order to cater to the increased demand for our products. We are happy to declare that this programme is now complete, and the Dahej facility has commenced production at its elevated capacity. Fermenta has always been committed to delivering quality products to its valued customers, and going forward as well, we will work towards our endeavour for excellence through continuous improvement in all our processes.”
Cipla Ltd. | Q4FY19 Result Update | Strong results beat estimates on the back of US gain Mumbai India: Cipla reported Q4 results above the estimates. In Q4FY19, net sales came at ` 42.7 bn, up 22 percent YoY (above est. ` 34 bn), largely driven by US sales of USD 163mn, up 55 percent YoY (our est. USD 108 mn), on account of a key product Gsensipar being launched. The management has not given any further guidance on Gsensipar as it is currently under litigation. Normalized growth was seen in the Middle East business and tender business, on a sequential basis. The India business reported sales of ` 15 bn, up 11 percent YoY (below est. ` 16.2 bn). South Africa and the global access business stood at ` 8.2 bn (below estimates ` 9.1 bn). The management said that the disruption in the Middle East and Venezuela are expected to continue and these markets are expected to normalize by FY20. We believe that cost-saving initiatives will help to boost the EBITDA margin by 100 bps in FY21, largely on account of US gains going ahead. We believe the growth story has started picking up. We tweaked slightly our FY19/20/21 estimates. At the CMP, the stock trades at 24.0x FY20 and 20.4x FY21 EPS of ` 23.0 and ` 27.1 respectively (earlier ` 24.0 FY20 and ` 29 FY21). Maintain ACCUMULATE with a revised target price of ` 596 Q4FY19 result snapshot: Cipla reported Q4 results above our estimates. Net sales grew 22 percent YoY, led by strong performance of the US business, and gross margin came higher at 65 percent owing to the 326 bps growth YoY. R&D spend for Q4 stood lower on sequential basis at ` 3 bn. EBITDA for the quarter came in at ` 9.6 bn, mainly driven by traction in Gsensipar sales in the US owing to a margin of 22 percent YoY. PBT was impacted due to impairment charges of ` 2.07 bn incurred in the US acquisition. Q4 PAT stood at ` 3.6 bn, up 105 percent YoY (above est. `.2.5 bn). Pharma Bio World
press release Sun Pharma Announced Late-Breaking Phase 2 Data Showing Potential of ILUMYA™ (tildrakizumab-asmn)
Mumbai, India and Princeton, NJ: Sun Pharmaceutical Industries Ltd. announced interim results from a Phase 2 study of interleukin-23 (IL-23) inhibitor ILUMYA (tildrakizumab-asmn) in patients with active psoriatic arthritis that was presented in a late-breaking oral presentation at the Annual European Congress of Rheumatology (EULAR 2019) in Madrid, Spain (abstract #LB-0002). The interim analysis revealed that over 71 percent of patients treated with ILUMYA™ experienced a 20 percent improvement in joint and skin symptoms (ACR20), meeting the primary endpoint of the study. The interim results showed ILUMYA was well tolerated with a low rate of serious treatment-emergent adverse events. ILUMYA is approved in the US for the treatment of adults with moderateto-severe plaque psoriasis who are candidates for systemic therapy or phototherapy and is being investigated for psoriatic arthritis. Psoriatic arthritis, which affects up to 42 percent of people with plaque psoriasis, is an inflammatory condition that impacts both the joints and skin. It is painful, causes fatigue, and can lead to swelling and stiffness of the joints that may reduce range of motion. If left untreated, this chronic condition can lead to permanent joint damage. “As a researcher and clinician, it’s encouraging to see these improvements in pain, joint swelling, and skin plaques. Our interim findings showed that about half of the patients treated with 100 mg or 200 mg of tildrakizumab saw a 50 percent improvement in psoriatic arthritis symptoms and about a quarter saw a 70 percent improvement within 24 weeks,” said study investigator Philip J. Mease, MD, MACR, Director of Rheumatology Research at the Swedish Medical Center/ Providence St Joseph Health and clinical professor at the University of Washington School of Medicine, Seattle, WA. “These data insights are promising for patients who continue to struggle with the impact psoriatic arthritis on their daily lives.” The Phase 2 study interim results showed that across all patients receiving ILUMYA, 75.3 percent experienced a 20 percent improvement in symptoms of psoriatic arthritis (ACR20) at week 24 compared to 50.6 percent of patients on placebo. The findings were similar in patients receiving 100 mg or 200 mg of ILUMYA on a quarterly dosing schedule. For some patients on 100 mg ILUMYA, results were seen as early as 8 weeks. Furthermore, an average of 47.1 percent of all patients receiving ILUMYA achieved an ACR50 response with some results seen as early as 12 weeks, compared to 24.1 percent of patients on placebo. The interim results also showed ILUMYA was well tolerated with a low and comparable rate of adverse events to placebo. Serious treatmentemergent adverse events occurred in 2.2 percent of patients treated with ILUMYA and 2.5 percent in those on placebo, with no patients discontinuing treatment due to these events. The most common adverse events through week 24 included common cold (nasopharyngitis), upper respiratory tract infection, and headache. There were no reports of candidiasis, inflammatory bowel disease, major adverse cardiac events, malignancy, or deaths. “We are committed to the continued clinical development of ILUMYA and are pleased with the interim results in our first study for psoriatic Pharma Bio World
arthritis,” said Kyle Ferguson, Business Unit Head, Vice President Sales & Marketing, Sun Pharma. “To help us determine the potential of ILUMYA across psoriatic disease, we are now exploring a possible Phase 3 trial for psoriatic arthritis with regulatory authorities.”
Sun Pharmaceutical Industries Ltd. | Q4FY19 Result Update | Q4 results below estimate | Impacted by one-off drop in India sales
Mumbai India: Sun Pharma reported its Q4FY19 result below estimate, mainly due to a drop of ` 10.85 bn in India sales due to the one-time inventory absorption of Aditya Medisales and the forex loss of ` 520 mn. Net sales stood at ` 70.4bn, up 5 percent YoY (vs the estimate ` 74.6 bn). Gross margin was at 73.9 percent, above our estimate 71.5 percent. In Q4, there was a sharp increase in other expenses (amounting to ` 27.3 bn) due to the direct-to-consumer (DTC) promotional expenses for Ilumya and consolidation of Pola Pharma. The EBITDA margin stood at 14 percent, declining 1000 bps YoY (EBITDA margin would have been at 25 percent after adjusting for the ` 10.85 bn drop in India sales hit). The adjusted PAT for the quarter came in at ` 6.3 bn (vs the estimate of ` 8.5 bn). The R&D spend for the quarter was stood ` 5.67 bn, 8 percent of sales. We see improving revenue visibility after the Halol clearance and planned specialty launches. However, we believe that the margin pressure from the specialty business-related investment will keep return ratios in check. We see Sun as the best-positioned to transition into specialty pharma over the medium term and believe near-term headwinds could yield a better entry point. We recommend BUY at these lower levels with a revised target price of ` 491 at FY21 EPS of ` 22.3. Adjustment of one time sale impact of ` 10.85 bn: Sun’s Q4FY19 sales would have come at ` 81.3bn up 21 percent YoY. Adjusted EBITDA stood at ` 21 bn which implies a margin of 25 percent against the reported 14 percent. Adjusted PAT for the one time impact would have come above estimates. Our EBITDA assumptions: We have calculated the EBITDA margin (on YoY basis) for FY20 at 23 percent, assuming: an increase in employee costs, as Sun expands the specialty sales force; R&D expense at 8 percent of sales for FY20 (vs 7.5 percent in FY19), with a higher spend on product labelling and trials on other indications (this does not include any additional in-licensing done by the company through the course of the year); and marketing and other front-end costs associated with the launches, which are likely to remain elevated in FY20. Outlook and valuation: The specialty business does improve the sustainable revenue base over the medium term, but meaningful contribution is some time away (H2FY20, in our view). We do see improving revenue visibility with the Halol clearance and planned specialty launches, but believe that the margin pressure from the specialty business-related investment will keep bottom-line growth in check. The execution of its specialty pipeline and a market share rampup will be key triggers for the stock. At the CMP, the stock trades at 21x FY20 EPS of ` 19.8. June 2019 ► 47
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Orbit Technologies Pvt Ltd B-50 Indl Estate, Sanath Nagar Hyderabad, Telangana 500 018 Tel: 040-67216354 Fax: 91-040-23801579 E-mail: orbit@orbitindia.com
Chintamani Engg Industries India Pvt Ltd 201 New Rahul CHS, Suyog Nagar Chulne Bhabola Road Vasai (W), Dist: Palghar Maharashtra 401 202 E-mail: info@chintamaniengineering.com
Zero Liquid Discharge Plants SS Techno’s evaporators are state-of-the-art units specially designed for your specific application, considering the physical/chemical properties and special characteristics of the effluent. Extensive technical knowhow and hands-on experience in the field, ensures the right solution at optimum cost of investment and operations. Thermal evaporation is an energy intensive operation. SS Techno’s evaporators are designed in multiple stage units (with or without thermal vapour re-compression) to ensure optimum steam consumption and power utilization. This keeps the cost of operation as low as possible. SS Techno’s evaporators have minimum scaling problems and require only chemical cleaning (CIP), usually once every fortnight. The plant is operated on a 24 x 7 basis. The condensate is clean with total dissolved solids, less than 150 ppm, and can be recycled back to the plant. The concentrated product is disposed-off as per the specific norms of the industry. It can be dried/disposed-off in landfills. If required, SS Techno supply specialty dryers such as screw conveyor dryer, SST dryer, spray dryer as a post-evaporation stage. After drying some of their customers incinerate in a regular boiler or sell as a valuable product. For more information, please contact:
SS Techno Ltd 502 Mayfair Towers 1, Wakdewadi, Shivajinagar Pune, Maharashtra 411 005 Tel: 020-66524431, 66524432 Fax: 91-020-66524434 E-mail: marketing@sstechno.com
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Polypropylene Filter Housings The polypropylene filter housings are made of ruffed reinforced polypropylene. They are recommended for low flow rates to higher flow rates in wide range of applications including residential, commercial and industrial. Available in 8”, 10”, 20” Standard models and 10”, 20” Jumbo models for higher flow rates. Leak-proof sealing with top seated Buna-N O-ring. Blue, black/San filter housing blue body with black cap, white body with white cap, clear body (SAN/PC) with white cap. Available in 8”, 10”, 20” sizes. Pressure relief/ bleed button on inlet side and cap ¼”, ½”, ¾” and 1” in/out connection. Max flow rates up to 8 lpm – 8” size, 10 lpm - 10” size, 40 lpm – 20” size. Max temperature 70 oC and operating pressure up to 6 kg/cm 2. Big Jumbo filter housing large capacity housing is suitable for high flow applications. Available in 10” and 20” sizes to meet your needs – 4.5 DOE filter cartridges 1-1/2” in/out connection. Max flow rates 50 lpm - 10”, 100 lpm - 20” pressure relief/bleed button on inlet/outlet side of cap. For more information, please contact: National Card Board Mill Plot No: 140-2/B/2, GIDC Estate Ankleshwar, Dist: Bharuch, Gujarat 390 002 Tel: 02646-252569, 222569 Fax: 91-02646-253002 E-mail: ncbmfilter@gmail.com
Monitoring Physical Parameters OCEASOFT brings a new dimension to solutions for monitoring physical parameters such as temperature, humidity and more. OCEASOFT worked closely with the Fondation Jean-DaussetCEPH international genetic research center, France, to carry out preliminary testing and develop a product that truly matches user needs. OCEASOFT created its new Cobalt X2 system for monitoring physical parameters to meet major challenges faced by life science professionals, including laboratories, hospitals and pharma companies: 1) Cobalt X2 simplifies daily tasks for users by enabling them to acknowledge alarms directly via the module’s colour touch-screen. Cobalt X2 also serves as a data collector and gateway for OCEASOFT’s wireless sensors, further simplifying installation with automatic connection. 2) Integrating LoRaWAN long-range connectivity, Cobalt X2 modules communicate wirelessly over large sites and inside buildings easily, benefiting from completely automated deployment. Cobalt X2 features distinct sensor channels to support any combination of up to four wired Smart-Sensors (with calibration parameters stored directly on-board) or wireless Bluetooth enabled sensors, giving users a cost-effective way to monitor up to four different pieces of equipment with a single module. 3) Cobalt X2 includes features designed specifically to respect applicable sector-related regulations: 21 CFR Part 11, EN 15189, and good practices guidelines (GxP). To ensure optimal service to customers, OCEASOFT has its own sensor calibration laboratory, accredited according to the ISO 17025 standard. For more information, please contact: OCEASOFT 250 Phillips Boulevard E-Wing, NJ 08618 U.S.A. Tel: +1-609-589-1668, +33 (0)4 99 13 67 30 Fax: +1-609-589-1669 E-mail: P.Besson@oceasoft.com
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Stirred Reactors Parr offers a wide choice of design options to meet the userâ&#x20AC;&#x2122;s individual installation or operating requirements. Stirred reactors have two different vessel mounting styles, fixed head design for users with multiple fed, vent and instrumentation need. The movable head design to users who wish to charge or recover reactants and products away from the operating area. Magnetically coupled stirrer drives are offered in high and low speed designs in four operating torque ranges. Heaters range from electric to circulatory jackets. Temperature controllers are available to fully integrate the process controller or as simple controls. Other available accessories for stirred reactors include internal cooling coils, bottom drain valves, condensers, custom stirrers, explosion-proof components, liquid gas filling and monitoring systems and many more. For more information, please contact: Orbit Technologies Pvt Ltd B-50 Indl Estate, Sanath Nagar Hyderabad, Telangana 500 018 Tel: 040-67216354 Fax: 91-040-23801579 E-mail: orbit@orbitindia.com
Centrifugal Pump with Permanent Magnetic Drive The CRP-M centrifugal pump range is equipped with a permanent magnetic drive in accordance with DIN EN ISO 2858 and strikes new paths especially for the design of the journal bearings, internal flows and pressures, magnetic drive system and axial thrust balancing. It finds application in chemical and petrochemical industry, tank farms, liquid gas industry, refrigeration and heat technology, power plant technology, Galvano technique.
For more information, please contact:
Ruhrpumpen India Pvt Ltd Plot No: G-33, SIPCOT Indl Park, Vallam Vadagal Sriperumbudur Taluk Kanchipuram, Tamil Nadu 602 105 Tel: 044-33229969, Fax: 91-044-33229902 E-mail: shah@ruhrpumpen.com
Bag Filter System Bag filter system is designed for optimum filtration performance. The range provides filtration solution for a broad variety of fluid applications in the process industry. They are particularly useful for filtering large volume of high viscosity liquids. Bag filter is constructed of filter housing, filter bags, internal cage to support bags, positive sealing arrangement and choice of end connections. The internal supports ensure bags will not burst as high differential pressures build up during operation. Operation unfiltered fluid enters the housing and is distributed evenly around the filter bags. Filtration takes place from inside to outside. Solids are collected on the inside of filter bag for easy removal. The filtered fluid then exits through the outlet pipe.
For more information, please contact: National Card Board Mill Plot No: 140-2/B/2, GIDC Estate Ankleshwar, Dist: Bharuch, Gujarat 390 002 Tel: 02646-252569, 222569 Fax: 91-02646-253002 E-mail: ncbmfilter@gmail.com
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SS Filter Housing Stainless steel filter housing is designed to offer wide range of fluid flow capacity and compatibility suitable for most types of cartridge filters. SS-304 and SS-316 brushed/electropolished material construction for max corrosion-resistance in a non-code filter housing. Swing bolt closure design with 150-psig (10.3-bar) max operating pressure assures secure sealing and easy cartridge changeout. Flow rates from 180 to 300-GPM. It is ideal for water, paints, photographic solutions, food and beverage products, petrochemical, pharma, plating solutions. All models available with vent and drains for easy cartridge change and maintenance. Accept 27 round filter cartridges in length 10”, 20”, 30” or 40” from variety band. Accept cartridges with double open-end (DOE). Optional for SOE O-ring and 22y O-ring fin-end configuration standard shell O-ring to be Buna-N: silicon, Viton and EPRM. For more information, please contact: National Card Board Mill Plot No: 140-2/B/2, GIDC Estate Ankleshwar, Dist: Bharuch, Gujarat 390 002 Tel: 02646-252569, 222569 Fax: 91-02646-253002 E-mail: ncbmfilter@gmail.com
Platinum-cured Silicone Hose Imavac is platinum-cured silicone hose reinforced with SS-316L helical wire. It has better transparency to visualize flow and kink resistance. Imavac is designed for material transfer application under high vacuum in pharmac industries. The product is more superior compared to Imafit in high pressure and high vacuum rating applications. It is also used for anti-static application. Imavac conforms to US FDA 21 CFR 117.2600 Food Grade Standard, USP Class VI and ISO 10993-1. It is certified by ROHS and TSE/BSE Certification (free of animal derived material), free of restricted heavy metals. It is free of phthalate/bisphenol/ volatile plasticizer. It has USFDA DMF accreditation #26201. Complete validation package available upon request. Imavac has high burst pressure-resistance compared to Imafit. It is designed for high vacuum rating applications. It has anti-static properties to dissipate static electrical charge makes it suitable for highly volatile flammable fluid transfer. It imparts no taste and odour. It is lot traceable. Its temperature range is -80°C to 180°C and is available with SS-316 L tri-clover end. It is sterilizable by autoclave, ethylene oxide gas and gamma radiation.
For more information, please contact: Ami Polymer Pvt Ltd 319 Mahesh Indl Estate, Opp: Silver Park Mira-Bhayander Rd, Mira Road (E) Thane, Maharashtra 401 104 Tel: 022-28555107, 28555631, 28555914 E-mail: mktg@amipolymer.com
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Air-cooled Heat Exchanger Pre-heaters, heat recovery units and similar air to air heat exchangers are designed and manufactured as per client’s requirements. Hot air and gases exiting processes in industries are used as heating medium to pre-heat process air by passing over finned air to air heat exchangers. Exhaust gas from fuel combination in generators, boilers, etc, is also used as heating medium. Their design incorporates wire-wound finned tubes or spiral finned tubes as dictated by the process conditions. The finned tubes have tabulators of suitable type to make the heat exchanger compact and economical. Air cooled after-coolers and inter-coolers can be custom-designed and manufactured to suit compressors. Base tubes of carbon steels, copper and copper alloys, SS-304 and SS-316 and other SS grades finned with galvanized mild steel, copper and SS fins are used in fabrication of air heating exchangers. The body material used so far is carbon steel and SS.
For more information, please contact: Reliable Thermocraft S No: 81/82, Plot No: 18, MIDC, Ambad Nashik, Maharashtra 422 010 Tel: 0253-6628665 E-mail: works@reliablecrafts.com
Thermic Fluid Air Heaters Thermic fluid (hot oil) heated air heaters for heating air for fluidized bed dryers, conveyor dryers, spray dryers, tray dryers. Thermic fluid heated air heaters for heating air using thermic fluids like Shell Thermia, Marlotherm, Dowtherm and other petroleum oils as heating medium are manufactured using root soldered wire wound fin tubes. Our designs result in economical designs coupled with low air side pressure drops. Thermic fluid air heaters made are being used in dryers in coated paper industry, steel strip coating and finishing lines, chemical and dye dryers. Base tubes of carbon steels, copper and copper alloys, SS304 and SS-316 and other SS grades finned with galvanized mild steel, copper and SS fins are used in fabrication of air heating exchangers. The body material used so far is carbon steel and SS.
For more information, please contact: Reliable Thermocraft S No: 81/82, Plot No: 18, MIDC, Ambad Nashik, Maharashtra 422 010 Tel: 0253-6628665 E-mail: works@reliablecrafts.com
Romaco Innojet VENTILUS V 5 Processing Machine The laboratory-scale version of the technology is used for granulating, drying and coating particle sizes from 10 µm to 2 mm. Due to its special design and enhanced processing efficiency, the Innojet VENTILUS V 5 allows up to 25 per cent shorter batch times. The homogeneous flow conditions inside the cylindrical product container enable extremely gentle intermixing of the batch. The process air is controlled by the ORBITER booster, an ingenious container bottom consisting of overlapping circular plates. Together with the ROTOJET, the central bottom spray nozzle, the ORBITER booster forms an innovative functional unit that meets all the requirements for linear scale-ups. The air flow bed technology ensures accurate control of the product movement and equally precise application of the spray liquids. The resulting formulations can achieve the required release profile with spray liquid lass then 10 to 15 per cent. For more information, please contact: Romaco Group Am Heegwald 11 76227 Karlsruhe Germany Tel: +49 (0)721 4804 0 Fax: +49 (0)721 4804 225 E-mail: susanne.silva@romaco.com
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Walk-away Process Development Reactors Enjoy advanced reaction control and full automation with the Atlas HD, for reproducible, walk-away results. Advanced automation software enables chemists to set up complex multistep recipes, take control of all reaction parameters, and configure and automate existing lab equipment. The modular design of the Atlas HD allows it to be used for jacketed reactions, crystallisation and reaction calorimetry. You can conduct your lab’s entire chemistry on one Atlas HD jacketed reactor system with a wide vessel range – from 50 mL to 5 L – allowing pressures up to 200 bar and a temperature range of ¬90 to +250°C. For more information, please contact: Syrris Ltd Unit 3, Anglian Business Park Orchard Road, Royston SG8 5TW, U.K. Tel: +44 (0)1763 242555
Hygienic Aluminium Drives The innovative nsd tupH surface treatment by NORD DRIVESYSTEMS makes aluminium as corrosion-resistant as SS. The nsd tupH surface treatment is an outstanding anti-corrosion treatment for gear units, smooth motors, frequency inverters and motor starters in washdown-optimised cast aluminium housings. It produces a protective layer which is permanently bonded to the substrate material and makes gear units with aluminium housings as robust and durable as SS versions. In contrast to painting or coating, nothing can detach or flake-off. Damage remains locally restricted and does not spread. The surface is easy to clean and largely resistant to acids and alkalis. Even the use of high pressure cleaners or contact with many aggressive media is possible, so that nsd tupH drives are therefore an efficient alternative to painted geared motors or SS versions. In contrast to SS drives offered in only few variants, the nsd tupH surface treatment is feasible for almost all NORD aluminium products. For nsd tupH aluminium drives all DIN and standard components, including drive shafts, are made from SS. The fanless smooth surfaced motors prevent the spreading of germs and run very quietly. They are available as synchronous and asynchronous motors and comply with Efficiency Classes IE2, IE3 and IE4. NORD drives with nsd tupH comply with FDA Title 21 CFR 175.300 and are therefore suitable for food applications. They have been successfully tested according to ASTM D714 (blistering), ASTM D610-08 (corrosion), ASTM D1654-08 according to DIN EN ISO 2409 (scratching), ASTM B117-09 according to DIN EN ISO 9227 (salt spray test) and ASTM D3170 (Gravelometer). In addition, their resistance to cleaning agents which are commonly used in the food industry has been confirmed in tests. For more information, please contact:
NORD DRIVESYSTEMS Pvt Ltd 282/2 & 283/2, Plot No: 15, Village Mann Tal: Mulshi, Adj Hinjewadi MIDC Phase II Pune, Maharashtra 411 057 Tel: 020-39801-217 Fax: 91-020-39801-416 E-mail: monika.mishra@nord.com / pl.muthusekkar@nord.com
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Non-stirred Pressure Vessels Parr offers a broad selection of non-stirred pressure vessels in convenient styles, sizes and pressure ranges for many laboratory uses. There are many optional accessories and fittings available to customize your pressure vessel to meet and exceed user specifications include heaters, controllers, valves, gauge block assemblies and gas filling hoses. For more information, please contact:
Shell & Tube Type Heat Exchangers Shell and tube type heat exchangers are built in a wide variety of sizes and capacities. The heat exchangers are fabricated as per TEMA/ASME unfired pressure vessel codes and ASHRAE Standard. Heat exchangers for sea water marine application or with steel shells are as per customer’s specific For more information, please contact:
Orbit Technologies Pvt Ltd B-50 Indl Estate, Sanath Nagar Hyderabad, Telangana 500 018 Tel: 040-67216354, Fax: 91-040-23801579 E-mail: orbit@orbitindia.com
Swam Pneumatics Pvt Ltd C-2, Sector 3, Noida, Uttar Pradesh 201 301 Tel: 0120-4696222 Fax: 91-0120-2443283 E-mail: sales@swamatics.com
Process Oxygen Analyzer Barben Analytical offers OXYvisor, its second-generation process oxygen analyzer, which optically measures oxygen in either the gas or liquid phase. In the gas phase, the analyzer measures from trace (0.5 ppmv) to % level oxygen, and in the liquid phase, it measures dissolved oxygen from 1 ppb to ppm. The OXYvisor can be used for continuous oxygen measurement for a wide range of industrial process and laboratory applications. It detects oxygen in flare gas, nitrogen headers, and hydrocarbon and other process streams. It is commonly used to detect oxygen to prevent the corrosion of capital equipment and to ensure product quality. Typical applications include vapour recovery systems, annealing furnaces, produced water, enhanced oil recovery waterfloods, tank blanketing systems, and upstream to midstream natural gas processes. The analyzer uses a proven optical luminescence technique that offers high accuracy, dependability and low maintenance. Its optical technology contains no membranes, which are susceptible to fouling, or electrolyte, which can poison or fail. The unique, industrialized optical oxygen sensing technology is based on proven quenched luminescence measurement principles. The OXYvisor provides supervisory-type monitoring capabilities with advanced diagnostic, auto calibration and remote validation capabilities. This functionality allows users to take significant process actions on alarm conditions at remote locations with high confidence, while significantly reducing maintenance and calibration needs. OXYvisor can be used in conjunction with Barben’s BOSx Series, FiberSense, FlexSense and SafeTap sensors. It has been tested and approved for direct use in Zone 2, Group IIC and Class I, Div 2 Groups A, B, C, D hazardous areas. It is NEC- and CEC-certified for North America and has ATEX and IEC global For more information, please contact: Barben Analytical 5200 Convair Drive Carson City, NV 89706, U.S.A. Tel: +1 775-883-2500 Fax: +1 775-883-6388 E-mail: sales.barbeb@ametek.com
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Air-cooled Condensers Air-cooled vapour condensers to condense steam and organic vapours using ambient air as the cooling medium. Wire wound fin tubes are used for making the condenser coils compact and economical. Base tubes of carbon steels, copper and copper alloys, SS-304 and SS-316 and other SS grades finned with galvanized mild steel, copper and SS fins are used in fabrication of air air-cooled condenser. The body material used so far is carbon steel and SS. The company designs complete fin fan heat exchanger assembly and also supply as assembled unit comprising of finned tube condenser coil, the transition piece and the fan. For more information, please contact: Reliable Thermocraft S No: 81/82, Plot No: 18, MIDC, Ambad Nashik, Maharashtra 422 010 Tel: 0253-6628665 E-mail: works@reliablecrafts.com
Impact Protection Gloves Aquila offers impact protection gloves as an integral part of an all-round hand protection strategy. In gloves, the ability to absorb impacts and prevent injuries to the fingers/back of hand is inextricably linked to other factors such as providing a suitable grip on the palm/finger area This means that it is important to carefully match the glove to the specific tasks together with other requirements such as back of the hand protection, wrist security and good grip in oil, mud or other fluids. In the case of impact protection gloves, this means not only protecting against blows, nips, abrasions, etc, but to do so with the greatest comfort and least interference plus having enhanced grip over the bare hand. Such gloves should not be tiring to wear as not only is this undesirable in itself, but tired operators with tired hands are more likely to make errors and have accidents. Aquila have considered many materials and types at different prices, and chose impact pads mainly made of TPE (thermalplastic elastomer) otherwise known as TPR (thermalplastic rubber) after finding that this material greatly aids wearability and enhances dexterity, so ensuring that users keep their gloves on and keep working longer, better and safer. Over and above the specific impact resistance, gloves are usually required to offer more complex characteristics in combination, eg, impact resistance with cut resistance, high visibility colouration, wrist protection, secure retention, and high grip finger/palm area, eg, coated with sand nitrile and thermally insulated. Aquila have some eleven definitive types of multi-functional impact gloves â&#x20AC;&#x201C; taking just two examples with CE Certification to EN420/en388 we may look at the TOG6W range - an exciting development in the Aquila oil and gas TPR glove range, which offers cushioned silicone protection shielding against blunt force impacts, with an unusually high degree of comfort down to -50°C. It is ideal for use in the oil and gas industry, also in cold or refrigerated stores and warehouses and for outdoor work in cold environments. A secure grip on heavy equipment in wet and dry conditions, such as in oil and chemical production, is greatly aided by the sand impregnated nitrile coating which extends over the whole palm and finger gripping surface. Other features include high visibility colour to ensure that it may be seen and avoided by other workers in the area, also an opening cuff with Velcro closure for speed of fitting/removal, eg, quick removal in an emergency and for security in use. The Aquila TOG4B/G in either blue or grey is a TPR impact resistant glove with cut 4 level (ISO13997 level E) protection developed for high performance hand protection in the oil and gas industries. It is also of great value as personal protection equipment (PPE) for the utility and mining industries where it delivers cut protection throughout the glove, ie, the whole hand/finger/cuff, by virtue of its advanced Alkimos yarn technology. For more information, please contact:
The Industrial Marketing Agency 68 Ampthill Road, Shefford Bedfordshire SG17 5BB, U.K. Tel: +44 1462 850040 E-mail: sue@theindustrialmarketingagency.co.uk / info@theindustrialmarketingagency.co.uk
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events diary
Date: 16 – 18 July, 2019 Venue: Pragati Maidan, New Delhi
Dates: 8-11 August 2019 Venue: India Exposition Mart, Greater Noida
Indian Pharma Expo (IPE) will provide an opportunity for the participating companies to display their products & services to the gamut of visitors, globally from pharma and healthcare industries. The 3-day expo will bring together eminent personalities from various sectors of pharma, nonpharma and healthcare industries. IPE is one stop juncture to all those who are planning to expand their business through various channels of franchise and distribution; as well as wholesalers and hospital purchase personnel who seek to buy bulk products at concessional rates.
This event is a one-stop destination to address the
CIMS Medica Boomerang, Unit No. 403 B1 Wing 4 th floor, Chandivali Farm Road, Chandivali, Andheri (East), Mumbai - 400 072. India Tel: +91-22-66122612 / 627 Email: ipe@cims.co.in
manufacturing requirements of the OEMs of various industry sectors in Tier II and Tier III cities of India. It will cover the entire gamut of metal working machine tools for both metal cutting and metal forming including automation and robotics, tooling systems, CAD/CAM and other technologies essential for today’s manufacturing. Indian Machine Tool Manufacturers’ Assn Bangalore International Exhibition Centre 10th Mile, Tumkur Road Madavara Post, Bengaluru Karnataka 562 123 Tel: 080-66246600 E-mail: imtma@imtma.in
Dates: 25-27 September 2019 Venue: India Exposition Mart, Greater Noida
Date: 4-6 December, 2019 Venue: HITEX Exhibition Centre, Hyderbad
Electronica India is the leading platform in India focusing on electronic components, systems and applications. It features semiconductors, embedded systems, display, micro and nano-systems, and sensor technology, automotive, wireless and much more.
BioPharma World Expo 2019 is the best platform for both Indian and international manufacturers/service providers/ startups connected with pharma machinery, CR AMS, CROs/CMOs, packaging, logistics, exports, APIs, generics, biotech, regulatory affairs, etc . It offers a unique opportunity to meet, network and establish business partnerships. The concurrent conference tracks would highlight latest technological developments, market trends, investment opportunities and challenges facing the industry. The technical sessions would cover pharmaceutical technology, biosimilars, green chemistry, compliance, etc.
Messe Muenchen India Pvt. Ltd. INIZIO 507 & 508 Cardinal Gracias Rd Chakala, Andheri (E) Mumbai 400 099 Tel: 022-42554700 Fax: 91-022-42554719 E-mail: info@mm-india.in
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Jasubhai Media Taj Building, 210, Dr. D.N. Road, Fort, Mumbai - 400 001 Tel: 91-22- 40373636 Email: amrita_patil@jasubhai.com
Pharma Bio World
bookshelf The Future of Pharma – Evolutionary Threats and Opportunities Author: Brian D. Smith Price: ` 3743.00 No. of Pages: 194 Publisher: Routledge About the Book: Pharmaceutical industry makes a notable contribution in Indian economy. Tracing back to history indicates its success so far. Owing to the profits-and-dividends this industry has added and also due to its counter-cyclical stock market trends, investors consider this industry as a relatively low-risk one. However with significant global implications for employees, shareholders, governments, and patients, this important contribution appears to be petering out due to economic crisis. There are numerous examples indicating the stalling of the pharmaceutical industry. This book – the future of Pharma – throws light on the reasons for this potential decline through an in-depth analysis. It speaks about the emerging landscape, changing marketplace of mass-market consumers, institutional healthcare systems, innovative therapies as the alternate source of commercial value, super-efficient processes, supply chains and operations, closer customer relations, and increasingly tailored health services. The book also has mentioned about various significant long-term and mid-term challenges. The author Brian Smith’s insights are basically the wake-up call and a first step forward for all concerns with the future of this industry.
The Antidote: Inside the World of New Pharma Author: Barry Werth Price: $ 30.00 No. of Pages: 448 pages Publisher: Simon & Schuster About the Book: This book is about a ground-breaking close-up of Vertex – an upstart pharma company. Here in this time-relevant book, the author Barry Werth has leveraged his experiential insights spanning more than two decades and explained the indispensable world of Big Pharma. The book is about the rise of charismatic Joshua Boger after his leaving Merck, then America’s most admired business. The book takes the readers to the olden days and narrates a real-life story about founding a drugcompany, which eventually challenged industry giants and transformed health-care. The author described the tumultuous early days of the business, the bold endurance, and the eventual success.
FASTtrack: Pharmaceutical Compounding and Dispensing (FASTtrack Pharmacy) Author: Christopher A. Langley (Author), Dawn Belcher (Author) Price: ` 1,711.00 Pages: 217 Publisher: Pharmaceutical Press About the Book: This book has been designed to assist the students in understanding the key dosage forms encountered with extemporaneous dispensing. The book precisely focuses on the comprehensive take-away for the students through providing concise and bulleted information, key points, tips, and all-time important self-assessment sections. The content has been structured through various MCQs, case-studies, sample essay questions, and worked-out examples. It also includes the ultimate lecture notes and is a must-read for all pharmacy students. Readers can even now have an easy access to online videos demonstrating various dispensing procedures.
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Process Industry's Gateway to Indian Market International Exhibition and Conferences
ChemTECH
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