Pharma Bio World December 2017 by Pharma Bio World

www.pharmabioworld.com PHARMA BIO WORLD VOL 16 ISSUE 05 DECEMBER 2017 MUMBAI TOTAL PAGES 64 ` 150 GUJARAT - 2018

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Pharma Bio World

n the Front Lines of Serialization 40

b n a an an t

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INTERVIEWS 08

“Homeopathy is getting more and more organized with each passing day” - Nishant Jain, CEO, B Jain Pharmaceutical Pvt Ltd.

FEATURES 10

Pharma Technology will be Shaped by New Challenges for Product Manufacturing - Rahul Dev

Leverage the Industry 4.0 Revolution to Meet Market Challenges - Bob Lenich, Michalle Adkins

State-of-the Art Technologies Facilitate the Combating Sub-Standard Medicines - Amit Chopra

Considerations for Extraction, Stabilization and Quantifi cation by PCR for Sensitive Sample Such as RNA - Andrew J Birnie, PhD

Why Paper-Based QMS Systems Have Become Obsolete for Contract Manufacturing - Patricia Santos-Serrao, RAC

DOCTOR’S PERSPECTIVE 34

The Evolving Treatment and Rehabilitation for Spinal Injury Patients - Dr H S Chhabra,Secretary, Spinal Cord Society, Medical Director, India Spinal Injuries Center

NEWS UPDATE 40

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interview

NISHANT JAIN

“Homeopathy is getting more and more organized with each passing day”

8  December 2017

“As per the data available on AYUSH Ministry website there are over 2, 46,772 homoeopathy practitioners, 245 hospitals and 6958 government dispensaries. T h e r e a r e 1 87 h o m e o p a t h c o l l e g e s with a capacity to churn out 13,444 homeopaths every year. And, according to the Lancet, Indian homoeopathic market is growing at 25% a year, and more than 100 million people depend solely on this form of therapy for their health care, the popularity of the homeopathic remedies shows no signs of abating,” says Nishant Jain, CEO, B Jain Pharmaceutical Pvt Ltd. In an email interaction with Mahesh Kallayil, he shared a positive future vision for homeopathic industry in India. Can you please provide an overview on B Jain Pharmaceuticals? B. Jain Pharmaceutical came into existence in the year 2010, and we have consistent growth of 25-30 percent (Year on Year). And in a span of less than 7 years, B. Jain has Pan India presence with a diversified network of more than 250 dealers/distributors and exporting homeopathic medicine to more than 35 countries. A cumulative experience of more than 50 years in serving the Homeopathy through publishing house and a sheer dominance in the homeopathic book market with 85% share greatly helped the organisation in winning the trust of all the stakeholders and serving the market with quality products. B. Jain is proud to be the only homeopathy company in Asia with Indian GMP, Health Canada, and ISO 90002008 and audited by NSF Pharma Biotech all at the same time. Under its expansion plans, B. Jain Pharmaceutical has recently entered into the personal care industry under the brand name Omeo.

Could you also tell us about the research activities and facilities at B Jain Pharmaceuticals? The R&D Department of B.Jain Pharmaceuticals is the backbone for the quality we stand by, and it is focused on conducting clinical trial studies for new products and services, developing new products, and improving the existing product line. Only when an accelerated stability report is cleared, products are launched in the market. So, each product coming out of B.Jain pharmaceuticals is a tried and tested which makes it efficacious and safe. W h a t d o y o u s e e t h e c o m p a n y ’s competitive edge? B.Jain is the first Asian homeopathic pharmaceutical company to be NSF audited. NSF is an accredited independent third party certification body. NSF Pharma Bio World

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interview

Pharma’s biotech division conduct audits for pharmaceutical firm as per USFDA guidelines. It is one of the strictest audits for any OTC medicinal product to be sold in U.S; be it of allopathy, homeopathy, or any other science. Besides, all medicines are prepared from authentic herbs and chemicals. Also, we have our own farms where herbs are grown in right environment & condition. Consequently, we are exporting medicines to more than 25 countries. Moreover, B.Jain’s recently launched personal care range is free from SLS and Paraben and it offers the vast benefits of Homeopathy. How do you account for Homoeopathy as an industry? How would you describe the current scene of Homoeopathy industry from a global perspective? Homeopathy is getting more and more organized with each passing day. There are more than 375 manufacturers of homeopathic medicines in the country, but there are only a few professional players who are stick to strict quality norms. As far as sale is concerned, it was very challenging till now as 10  December 2017

medicines could be sold only via homeopathic pharmacies. Now, as per Government’s new policies, license holders of allopathic medicines can also sale homeopathic medicines from their counters and this initiative will give a great push to the industry in future. According to Assocham’s report the current homeopathy market in India is estimated to be around Rs12.5 billion and its size in the global market has gone up to Rs135 billion. France, is the largest market in the world with an estimated worth of Rs. 45 billion. The scenario is going to change completely, and I’m hopeful that market will grow as imrpved availability will make a lot of difference. As far as global perspective is concerned, Homeopathy has been already recognized as one of the most popular CAM (complementary and Alternative Medicine). As per the reports of WHO, Homeopathy is one of the most commonly used forms of herbal medicines. There is a large market for homeopathic products around the world. For example, in 2008, Australia spent 7.3 million US dollars on homeopathic medicines; France spent more than 408 million; Germany 346 million

and the United Kingdom more than 62 million US dollars. In the United States, adults spent 2.9 billion US dollars on homeopathic products in 2007. So, overall all perspective and figures indicate that Homeopathy is growing and is bound to grow more. Tell us where the Homoeopathy industry stands in the Indian landscape today? What are the challenges for a Homoeopathy manufacturer in India? As per the data available on AYUSH Ministry website there are over 2, 46,772 homoeopathy practitioners, 245 hospitals and 6958 government dispensaries. There are 187 homeopath colleges with a capacity to churn out 13,444 homeopaths every year. And, according to the Lancet, Indian homoeopathic market is growing at 25% a year, and more than 100 million people depend solely on this form of therapy for their health care, the popularity of the homeopathic remedies shows no signs of abating. One of main challenge has been availability of homeopathic medicines and sales of homeopathic medicines restricted only to Pharma Bio World

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interview homeopathic pharmacies which are unlike Ayurveda, Unani or Naturapathy, but now with a change in the law we are really looking forward to overcome this challenge as Government has permitted the sale of homeopathic medicines from allopathic counters, too. How has the GST impacted the Homoeopathy industry? The sales got badly hit as there was lot of confusions over which product/category falls under the particular slab, and the entire industry is struggling with this chaos. Fortunately, some revisions were made later and now things seem to be coming to normalization. In the long-run, there is no doubt that GST is very much beneficial for the industry. There are lots of myths and misconceptions about homoeopathy. As a top player in homoeopathy manufacturing, how will you address these claims? All the principles of homoeopathy are based on robust logic and experimental data. Various myths like Homeopathy have slow effects and it’s only to treat chronic disorders are just fabricated, and absolutely myths. Homeopathy gives very fast results but the medicine should be based on homeopathic principles of Simillumum. Homeopathy is not only good for chronic, but even acute disorders like cough, fever, pain etc. Renowned IIT Physicist, Dr. Jayesh Bellare who carried out experiments with high dilutions of homeopathic medicines and found that even at higher dilutions to the extent of 1000C, the dilution carries the properties of the original substance. There are many such research studies being carried out all over the world in the present times. Can we have your take on government policies to support homoeopathic manufacturing in India? In this time when Health status of the country is a major concern Govt. is trying to uplift 12  December 2017

alternative medicines – all sciences under AYUSH are being promoted so as many people can get benefitted and can get affordable medical care. Govt. is opened many homeopathic dispensaries in past 5 years and this step will make homeopathy more in reach of layman. In this time of antibiotic resistance in India homeopathy shall be a next option for people to choose from. Govt. has been very supportive seeing the benefits brought about by homeopathy. Also, the latest changes in Schedule K of Drug and Cosmetics Act is a welcome step which has been approved only by support form Govt. Ministry of AYUSH has provided overwhelming support to bring and implement these changes which will opens up a new untapped area for homeopathy as a whole. The most crucial change is to allow the sale of homeopathic medicines from allopathic counters. As a homoeopathy manufacturer, what are your views on ‘Make in India’ initiatives? The company wants to promote the dream of Make In India to increase the global export of Indian homeopathic products in the world by increasing the share of Indian homeopathic medicine in the world market. As it is clear that market of homeopathic medicine is sharply increasing worldwide we need to excel in the production of medicine on International standards to promote Make In India products worldwide. I would call the belief that “german medicines” are better has to be changed as India has capability to produce homeopathic medicines of highest quality and at par with any international standard. Even, as per the studies of WHO, Homeopathy is one of the most commonly used forms of herbal medicines. There is a large market for homeopathic products around the world. For example, in 2008, Australia spent 7.3 million US dollars on homeopathic medicines; France spent more than 408 million; Germany 346 million and the United Kingdom more than 62 million US dollars. In the United States, adults spent 2.9 billion US dollars on homeopathic products in 2007.

What are your thoughts on integration of conventional medicine and alternative medicine? I would say that’s the need of the hour. As every science has its own scope of limitations and people should get the best of all pathies and they should have the right and informed choice to choose from. If all alternative system of medicine can be brought together at one platform the disease burden on society can definitely be decreased. How do you see Homoeopathy in India in the year 2020? Homeopathy is bound to grow with the number of patient database using homeopathy is increasing as people want safer options for treatment for sure. It can also play an important role in dealing epidemics with substantial rate of success, and will emerge as best remedy for allergies. What are the next steps for B Jain Pharmaceuticals? We are working to extend our outreach in India and as well as in the global market. We are also bringing out more products and medicines for lifestyle disorders. Our personal care range is already getting a good response as more and more people these days prefer to use safer cosmetics and personal care products.

Please elucidate on RadarOpus a nd its s ignific ance in Indian homoeopathy market? RadarOpus homeopathic software is unique – a Single Intuitive Interface for homeopaths that includes Repertory, MateriaMedica, Patient Files. There’s even a built-in webbrowser! All the essentials combined in a single homeopathic software program.

Pharma Bio World

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 16 ď&#x201A;&#x192; December 2017

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 â&#x20AC;&#x201C; 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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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.

PHARMA BIO WORLD

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CHEMICAL & PHARMA INDUSTRY

Leverage the Industry 4.0 Revolution to Meet Market Challenges The rise of the fourth industrial revolution, or Industry 4.0, which combines digital and physical advanced technologies, can potentially transform the life science industry. This article looks into the extent to which life science companies have positioned themselves in relation to this transformation and the opportunities the switch to industry 4.0 offer them.

he Life Sciences industry — with its major investments in research, reliance on complex chemistry, and sophisticated understanding of human biology — is generally regarded as a technologically advanced sector. However, when it comes to manufacturing technology; the same processes that have been used since the mid-20 th century have remained. Until recently, this has been an acceptable strategy. But with increasing levels of complexity and increased competition in the market, Life Sciences manufacturing is going through a transformation. Today, Life Sciences manufacturing facilities can take advantage of stateof-the-art digital automation systems and seize opportunities to improve operations. Increasing market competitive pressures demand efficient operations, manufacturing flexibility, and integrated supply-chain management. Going forward, Life Sciences manufacturing companies must invest in the new technologies that digitization and the Industry 4.0 revolution enable to stay current, competitive, and compliant.

Bob Lenich Global Life Sciences Director Emerson Automation Solutions

Michalle Adkins Life Sciences Consulting Director Emerson Automation Solutions 20  December 2017

Currently, many companies operate with disconnected and inefficient legacy systems that are challenged to respond to dynamic shifts in manufacturing supply and demand. Companies have increased expectations for real-time release and for more visibility to all the manufacturing activity, data collection, and analysis.

Including the growing requirements from increasing regulatory scrutiny and cyber security means improved quality controls, better system management, and more access to data. Digital automation solutions hold tremendous potential to help Life Sciences companies address each of these exacting regulatory and market challenges. The Life Sciences Manufacturing Opportunities The idea and goals behind Industry 4.0 include connecting human resources, data, and physical machines in a cyber physical network. Although the Life Sciences industry is quite advanced in its application of technology, Life Sciences manufacturing operations historically have been very cautious in adopting new technologies. With high costs to re-validate a working, licensed manufacturing process after making a change, the regulatory environment has historically been a major barrier. This alongside other drivers resulted in Life Sciences companies focusing on new product development and sales rather than on optimizing operations. This traditional mindset is changing rapidly. The industry is facing strong price control pressures, the historic product lifecycle patent protection window is shrinking, and there are fewer opportunities for blockbuster products targeted at a large,

“Although the Life Sciences industry is quite advanced in its application of technology, Life Sciences manufacturing operations historically have been very cautious in adopting new technologies.” Pharma Bio World

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the order) to dramatically reduce this inventory carrying cost. To provide real-time release, leading manufacturers are: • Moving lab measurements from remote laboratory locations that require slow sample management processes to atline or in-line production points with no time delays. The expanded interfacing capabilities of digital automation systems to new sensors and analyzers make this work possible. • Using the in-line lab quality information to automatically adjust the production line versus having to wait for lab results, make a “manual” decision, and then deal with all the production that occurred during the wait. Digital automation with embedded advanced control and integrated analytical measurements can help ensure quality.

Source: American Productivity and Quality Center uniform global market. As these pressures grow, manufacturing effectiveness, flexibility, and reliability have become critical enablers for the industry to meet challenges. Digital automation systems have the potential to fundamentally transform manufacturing, enabling stepchange improvements in performance. A great example is how single-use manufacturing processes and advanced digital solutions dramatically reduce the initial capital spending and improve ongoing manufacturing operations. To take advantage of opportunities, many companies are developing a strategic manufacturing operations roadmap to inform how they modernize and digitize their manufacturing operations. These multi-year plans can deliver sustainable agile operations as well as improved cost-efficiency and control to provide a competitive advantage ultimately leading 22  December 2017

to better care for patients. Two core areas offer significant opportunities as companies leverage the new processes and digital technologies: throughput improvements and manufacturing flexibility. 1) Throughput Improvements In addition to having significant warehouse space costs, Life Sciences companies have significant amounts of working capital tied up in inventory. For example, to manage changing demands today, many companies keep an excess of 90 days of safety stock and have large amounts of intermediate and final product inventory with various quality statuses, but particularly those waiting on QA test results. Top quartile companies utilize real-time release (where an order is proven to meet specifications on completion of

• Adding equipment monitoring and process modeling, so that digital automation systems can predict potential problems to avoid them before they occur. • Using manufacturing execution systems (MES) to confirm that equipment is properly calibrated and in the correct state, that people are properly trained, and that the proper sequencing of work activity is occurring to avoid deviations. • Leveraging embedded digital exception handling methods to conﬁ rm that any deviations that do occur have been resolved quickly with no impact on release. • In addition to working capital savings, these techniques also reduce unit costs. Reductions in quarantined or lost product, reductions of in process material losses, and consistent batch execution all contribute to cost savings. 2) Manufacturing Flexibility Production lead times in the Life Sciences industry typically have been considerably Pharma Bio World

longer than lead times of other industries. But this is changing. The amount of exclusive time available to a company to produce a new drug is shrinking as generics and bio-similars get faster approvals. As target patient pools get smaller (fewer blockbuster medicines and more niche market medicines), manufacturing must be sized appropriately while also maintaining a global reach. Because the number of new products successfully completing clinical trials is increasing, more new products must go through the same supply chains faster. Companies are addressing these issues by: • Adding supply-chain complexity via outsourcing to contract development organizations, contract manufacturing organizations, and global logistics organizations to lower capital risks and to make sizing and new manufacturing capital decisions much later in the development cycle. • Applying advanced planning, scheduling, and modeling techniques across the complete supply chain to optimize in-house facilities and contracted resources for a combination of best cost and faster deployment. • Utilizing new manufacturing processes like single use or continuous manufacturing with smaller capital footprints, faster deployment, and higher utilization so that a new facility can have footprint 60-70% of a traditional site yet still produce more product in a shorter period.

• Developing modular, standards-based operations so that changing the manufacturing sequence and/or recipe for a new drug doesn’t require new equipment or re-validating the complete process, only what’s changed. • Ensuring consistent quality standards are maintained across these approaches by integrating the systems and leveraging their new modular standards so that crosssite comparisons can demonstrate consistent performance. Life Sciences manufacturing leaders are using modern, digitized infrastructure and applications to leverage standard building blocks, to integrate information flow globally, to facilitate planning/ scheduling, and to optimize their supply-chain performance. Using a mix of site-based and cloud-based applications provide the infrastructure to use consistent business processes and reporting to provide sustainable competitive advantages. Through digitization, including cloud computing, companies can develop global integrated supply-chain networks. Cloudbased networks make it much easier to link all players through a single integrated network, even those with different IT architectures or ERP systems, thus making networks more scalable.

Life Science organizations of all sizes are taking advantage of technological capabilities in manufacturing while incorporating a holistic strategy regarding GxP compliance to ensure the value will be fully realized. Industry 4.0 is here. Companies now can leverage it to modernize technical operations and corporate quality management. Advanced technology solutions and Industry 4.0 can lead to productivity gains and can secure a company’s competitive advantage, while also improving the robustness of product quality and the security of the supply chain to the patient. We are amid the next industrial revolution and are seeing a radical revamping of technical operations from the inside out. Based on the common principles of Industry 4.0, an innovation initiative can significantly improve agility and productivity issues, and provide quality operations with better tools to enforce product safety and supply-chain security.

Associated improvements in manufacturing flexibility can give real capacity gains. All gains from the existing assets can potentially delay or remove the need for other (more expensive) capacity increase investments.

“Advanced technology solutions and Industry 4.0 can lead to productivity gains and can secure a company’s competitive advantage, while also improving the robustness of product quality and the security of the supply chain to the patient.” 24  December 2017

Advance Your Operations with the New Industry 4.0 Revolution

Contact: bob.lenich@emerson.com

Pharma Bio World

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State-of-the Art Technologies Facilitate the Combating Sub-Standard Medicines Growth of international free trade and inadequate drug regulation have led to the expansion of trade in counterfeit drugs worldwide. Technological protection is seen to be the best way to avoid this problem. Different technologies came into existence and the pharmaceutical companies have been employing these technologies in order to detain illegitimate drugs in their supply chain.

he Indian pharmaceutical sector ranks 3 rd in the world as far as volume is concerned, and is ranked 13 th in terms of value. Being the largest provider of generic drugs globally, Indiaâ&#x20AC;&#x2122;s share in the global generic drug market is an impressive 20 per cent. As per the World Health Organization, 35 per cent of counterfeit drugs sold in various countries come from India. Also, approximately 25 per cent of medicines sold in India are of substandard quality. The Indian pharmaceutical industry is strong in the field of manufacturing, but it is crucial to improve its ranking in producing approved and quality medicines. Fraudulent drugs harm or kill millions around the world. Of these counterfeit drugs, the most common are those related to cardiovascular and cancer treatment. Further, there are various counterfeit antibiotics that are produced in large quantity. Additional common counterfeit drug categories include but are not limited to erectile dysfunction medicines, painkiller medicines, weight loss pills, psychiatric medications and medicines that are given during the treatment of various chronic ailments such as HIV, Diabetes, Alzheimer â&#x20AC;&#x2122;s disease, etc.

Amit Chopra Managing Director & VPGM India and Middle East Thermo Fisher Scientific 26 ď&#x201A;&#x192; December 2017

Every stakeholder involved in the pharma business, including the policy makers, can play a pivotal role in putting a stop to this globally alarming issue. For example, the drug manufacturers need to strengthen their process around security of the manufactured drug -from raw material identification through production, supply to the end-user and destruction of unused/returned/rejected

material including the packaging material. Players in the supply-chain process should closely monitor the movement of drugs from one point of sale/distribution to the other. Policy makers should frame stringent guidelines/regulations, increase the number of inspections on every stakeholder in the pharma business and drive campaigns that provide insight about counterfeiting and its implications to discourage such negligence. For many years, pharmaceutical companies have relied on a combination of covert and overt security features in packaging and occasional forensic analysis to identify counterfeit drugs. However, counterfeiters have found ways to quickly and accurately replicate those features to deceive authorities and patients. While combating through traditional approaches like laboratory tests, random batch checks, routine screens etc., are being carried out, it can, only be used to verify a small fraction of all suspected samples. It becomes imperative for companies to create a robust mechanism to identify counterfeit drugs and loop-holes in the supply chain while making significant contributions to support research and innovation for the pharma industry through state-of-the-art technologies. It becomes essential to make investments in high-end analytical instruments and consumables to support activities which will accelerate drug discovery, enhance productivity and enable regulatory compliance. By means of right technologies, manufacturers can achieve quality initiatives not just throughout the manufacturing process Pharma Bio World

INSIGHT INTO THE PHARMACEUTICAL AND BIOTECH INDUSTRIES

PBW Spotlights »Indian Pharma and Biotech

but also in the market place. There are products available in the market which examines chemical composition of all components of a pharmaceutical dosage and offers non-destructive, rapid and accurate raw material identification respectively. Handheld instruments are designed to detect a variety of applications, including incoming raw material identification, quality control and assurance, counterfeit product screening, process troubleshooting and quantitative analysis. Non-destructive, rapid and accurate raw material identification enabling immediate release of raw materials into production while also meeting the requirements of current good manufacturing practices (cGMP) and 21 CFR part 11 with minimal training required.

coatings to create a unique spectral fingerprint representing the authentic medicine. Such technological solutions enable leading pharmaceutical companies to quickly and effectively identify almost any pharmaceutical material from receipt to release. Currently, major global pharmaceutical manufacturers and regulatory authorities use such analysers to verify the identity of either raw materials or finished products. Innovations are allowing brand owners and government agencies to develop new and powerful approaches towards anti-counterfeiting. These products have facilitated the seizure of thousands of counterfeit drugs that would otherwise have entered the supply chain with serious consequences.

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Considerations for Extraction, Stabilization and Quantification by PCR for Sensitive Sample Such as RNA This article talks about careful selection of an extraction system that helps stabilize and protect targets, especially RNA, or which allows for immediate analysis.

he accessibility of PCR and qPCR systems has increased to where they are almost considered a commodity product today. This is certainly the case for end-point PCR systems and some qPCR units also allowing researchers to carry out gene expression analysis more conveniently and quickly. This accessibility has been an innovative development in the community and will continue to move research forward for years to come. There have been concerns with regards to reverse transcriptase (RT-PCR) and real-time RT-PCR analysis of sensitive sample types such as RNA due to the stability of the sample during process and storage. Just how much impact this has had upon the results may go unknown. Recent advances into techniques such as digital PCR and new advances in extraction stabilization systems have sought to address some of these concerns. Extraction In theory, the extraction process is a relatively trivial matter: disrupt the sampleâ&#x20AC;&#x2122;s cellular integrity and collect the released nucleic acids. However, it is never that simple. Multiple factors must be addressed. When performing any nucleic acid extraction (especially RNA), stability and integrity of that extract must be considered. Samples being extracted in remote field studies must also take into consideration logistical concerns such as power supply, temperature control, availability to equipment, and shipping if samples are not to be tested onsite immediately.

Andrew J Birnie, PhD Global Life Sciences Product Manager Cole-Parmer 28 ď&#x201A;&#x192; December 2017

Another concern with general tissue extracts is the heterogeneous mixture of cell states and types being sampled or extracted from. The result of performing an extraction from a mixed population of cell is apparent and will result in a gene expression profile which

represents, at best, an average for that cell population. When considering tissue extracts in diseased or infected sample against wildtype expression, care must be taken to limit the number of wild-type cells in the diseased sample as these may affect the expression profile, or the wild-type cells themselves may have an altered gene expression due to proximity to a diseased or infected cell. This has previously been documented when bulk extracts are compared with laser microdissected cells. Due to the above, an ability to extract smaller volumes reliably and minimize loss of target material, or in some instances perform expression profiles on one specific cell, has driven the development of singlecell gene expression analysis kits. The single-cell extraction and gene expression kits typically have few steps and contain reagents for the sample extraction, reverse transcription, a means to inhibit cellsourced RNase and the qPCR components, making it a rapid system. Due to the small number of targets, the extraction process can have an impact upon the results of the real-time RT-PCR which must be performed quickly. Contaminating DNA can be removed with the inclusion of a DNase treatment step, typical of most RNA extraction systems. The advantages of such kits are apparent as there are limited chances to lose sample, and the target can be the exact cell type that should be profiled. A limitation of such kits could be their apparent high cost per extraction, but the possible advantages of gene profiling experiments from one cell cannot be overlooked. Other more standard kits, such as silica column-based extraction systems that typically need more starting material than single-cell kits, require multiple liquid handling steps and washes, and require additional heating equipment and centrifugation. These type of extraction systems often require a specific kit for a Pharma Bio World

Figure 1: Quantification by PCR has become more accessible but care must be taken when choosing the correct unit for the correct application. sample type or to extract either DNA or RNA. Samples once extracted may be subject to degradation unless stored and treated correctly, especially RNA extractions. These kits are more commonly adopted, perhaps in part to the familiarity of the protocols, performance and the cost per extraction can be less than some other approaches. Development of new extraction systems has continued and recently a novel extraction system has been introduced to the market requiring only two steps, limiting the manual pipetting error which can occur when multiple pipetting steps are required, and can be completed in three minutes at room temperature. The Arcis Sample Prep Kit provides high-quality, PCR-ready templates without the need for additional laboratory equipment such as centrifuges or hot blocks that are required with other approaches. The simplified workflow has maintained high yields and the Arcis Sample Prep Kit is compatible with common applications such as PCR (end-point, RT-qPCR), real-time PCR, isothermal amplification (LAMP), sequencing (Sanger, Pyro and Pharma Bio World

Next Generation) and genetic profiling (electrophoresis). This novel Arcis Sample Prep Kit relies upon smaller volumes of starting material than some column-based systems and, unlike other products, can extract both DNA and RNA at the same time removing the need and cost associated with having separate DNA and RNA extraction kits. The system is not enzymatic and has an added benefit of stabilizing samples at ambient temperatures, both DNA and RNA, for extended periods of time with minimal impact on Cqs or sample integrity. Stability data currently shows 100+ days for DNA and 6 days for RNA when stored in the Arcis Sample Prep Kit at ambient temperatures. Developments such as the Arcis Sample Prep Kit could enable more robust analysis of transcript levels, especially for those assays which are targeting low target expression, by limiting the degradation common in extracted RNA targets as well as simplify the process of transporting temperature-sensitive nucleic acids between sites as no cold chain logistics would be required in most cases.

Techniques: qPCR Controls are key in any scientific approach and developments in the PCR/qPCR field have attempted to limit spurious amplicon production which negatively impacts upon the target experimentâ&#x20AC;&#x2122;s efficiencies. Polymerases have become better immobilized prior to PCR and primer and probe developments have also helped reduce inappropriate binding and amplification. Buffer formulation for polymerases has also enhanced the performance of polymerases and made them more specific, sensitive and tolerant to difficult templates. The results of poorly controlled qPCR have been well documented and can have significant impacts on the community and beyond. A well-documented issue which arose from publications in 1998 and 2002 in which an apparent association of the MMR vaccine and bowel inflammation with developmental disorders in children caused a number of incidences where children were not immunized. A number of court cases soon followed. December 2017 ď&#x201A;&#x201E; 29

developed to quantify DNA or RNA transcript copy number as accurately as possible. dPCR reaction components will be similar to qPCR and often use hydrolysis probes like qPCR. A differentiator from qPCR is that dPCR does not reference an internal control or standard curve instead counting the exact transcript number in the assay. This can increase the accuracy of the measurement when compared to qPCR. dPCR setup differs from qPCR in that after the similar reaction components are assembled, one large reaction mixture will then be partitioned into approximately 20,000 smaller reaction vessels by creating oil droplets within the reaction well. Each oil droplet has within it the required components for PCR to occur, and after amplification each droplet is then scored for presence or absence of the specific target being investigated and a profile for that target generated.

Figure 2: Protection from degradation for RNA extractions is an important and sometimes overlooked aspect of gene In these two papers, it was shown that the qPCR data was not correctly controlled and standard operating procedures were not followed, data analysis was incorrect and there were issues associated with the RT steps before the qPCR. The combined effect caused incorrect conclusions. This and other cases resulted in scientists in the community generating the MIQE (Minimum Information for Publication of Quantitative Real-Time PCR Experiments) guidelines. The goal was to develop guidelines to promote laboratory consistency, help ensure the integrity of scientific literature, and increase transparency of experiments. These guidelines also provide information necessary for providing the minimum information for evaluating and reporting qPCR experiments. 30 ď&#x201A;&#x192; December 2017

System (PCR hardware) effects must also not be overlooked when carrying out sensitive assays. In general terms, variability across a PCR/qPCR systems thermal block is best limited to as little as possible as variability in temperature control may impact the result. Ideally systems with high uniformity should be used to limit data variability. Systems such as the Eco/Prime Pro from Cole-Parmer which utilise a liquid filled block to deliver best in class uniformity would be examples of such systems. Digital PCR Digital PCR (dPCR) was first developed in the mid-90s and recently has grown in popularity due to investment from some of the larger manufacturers. The technique was

dPCR could still suffer from the issues previously discussed with regards to extraction but will have the advantage of scoring exact transcript number rather than determining this by plotting unknowns against a standard curve. dPCR has also been shown to have advantages in multiplex environments or when high sensitivity is required compared to other techniques. Conclusion There are several issues to be addressed when attempting to accurately define the transcript level of a specific target, not all of which have been covered here. Careful selection of an extraction system that helps stabilize and protect targets, especially RNA, or which allows for immediate analysis must be considered. The systems used after extraction must also be considered and careful selection regarding system accuracy may also factor into the decision.

Contact: response@coleparmer.in Pharma Bio World

Why Paper-Based QMS Systems Have Become Obsolete for Contract Manufacturing This article addresses the quality issues inherent in contract manufacturing.

Around the globe, life science companies have found it extremely advantageous to outsource significant activities to contract manufacturers. India, for example, has experienced massive growth and respect as a global hub for pharmaceutical contract manufacturing. Outsourced activities may include new drug protocol designs, preparation of materials submitted to the US Food and Drug Administration (FDA) and other regulatory bodies, and manufacturing of drugs for global pharmaceutical companies. For brand companies, the inherent advantages of outsourcing are numerous. It allows pharmaceutical and medical device companies to concentrate on their core competencies, and at the same time reduce labor and overhead costs. So why is there now a shift from accepting paper-based quality management systems (QMS) to electronic systems? When a brand company transfers a function to another organization, the contract manufacturing organization (CMO) becomes subject to the same regulatory action as its client. Contract organizations share with their customers the burden of compliance for all expectations handed down by global regulatory bodies. Effectively managing every requirement and nuance of regulatory compliance, quality and risk mitigation through a paper-based, manual QMS system is a daunting task that case studies have shown most companies fail to achieve.

Patricia Santos-Serrao, RAC Director Clinical and Regulatory Solutions, Pharmaceutical, Blood & Biologics MasterControl

Pharma Bio World

Case in pointâ&#x20AC;&#x201D;the FDA recently sent a warning letter to an Indian pharmaceutical contract manufacturer, stating that two of the companyâ&#x20AC;&#x2122;s active pharmaceutical ingredient (API) suppliers were not registered as manufacturers with the

agency. Despite this, the FDA says the company shipped their products with the API from these companies to the US, claiming itself as the original manufacturer. 1 The fallout to the contract manufacturer could have been catastrophic and the event could have been avoided if all parties understood and complied with the regulations. Those regulations, and the ability to manage to them, would have been more apparent and visible if an electronic QMS had been in place. The FDA has made it clear to US and global contract manufacturers that if they do not follow the regulatory compliance rules as if they themselves were the original manufacturer, then they may not be found to be in compliance. The actions that can be taken by the FDA or other regulatory bodies can result in a number of negative consequences, in addition to the warning and notifications themselves. These can include loss of business, damage to reputation and a serious hit to being competitive. Damage to Business. Depending on the scope of the violations and resulting notifications, clients and partners may be required to cancel current contracts and any future contracts may be in jeopardy as well. Companies that are unsuccessful in their attempts to solve the issues addressed in the warning letters or notifications may be forced to cease manufacturing or even shut down their facilities. Damage to Reputation. When the FDA sends and posts warning letters or notifications, they become part of the public record and thus accessible to the media, partners, competitors, customers December 2017 ď&#x201A;&#x201E; 31

and influential individuals. This can have far reaching impact on the contract manufacturer’s reputation as a company that is unwilling or unable to follow the established rules and regulations. Damage to Competitive Advantage. Contract manufacturing is a rapidly growing space and companies have to compete for an increasingly competitive market share. Competitors revel in their ability to capitalize on anything that will provide them with an advantage over their rivals. FDA warning letters and notifications received issues against a competitor are highly effective tools for negotiations. The extensive ways in which regulatory non-compliance and the resulting warning letters and notifications from regulatory bodies can damage a contract manufacturers business are almost limitless. For those items listed already, there are dozens more that can escalate from an original violation. This takes us back to addressing why paper-based QMS systems have become obsolete for contract manufacturers. The volume of regulatory compliance, quality and risk mitigation factors all contract manufacturers are subject to is significant in number and growing every day. The ability to identify and manage all of these required processes manually is all but impossible. Regulatory bodies are going to be looking much closer at companies who declare they still used paper-based QMS systems than those who have adopted an electronic system. Electronic QMS systems have a primary function that ensures original and contract manufacturers have built-in access to the regulatory requirements across the all phases of the manufacturing and distribution process, including aspects of customer relationship management and change controls. They make it possible 32  December 2017

for any organization subject to regulatory requirements to know that the “who, what, when, where, why and how” of manufacturing are addressed in a manner that helps facilitate compliance. Without the intrinsic advantage of an automated QMS, it has been proven in far too many instances that an inefficient paper-based QMS puts companies and lives at risk. Simply put, the QMS industry has made a number of technological advancements to help avoid regulatory infractions and the stumbling blocks that frequently cause problems and jeopardize compliance for original and contract manufacturers. Facilitating and maintaining regulatory compliance is indisputably essential for a contract manufacturer to be recognized as a quality driven and reputable organization. How an organization achieves a sustainable level of compliance can be a fluid, adaptive and manageable process, or it can remain difficult and tenuous. One of those conditions creates a long-term profitable state and the other does not. The fundamental difference is the implementation and use of a reliable and proven electronic QMS versus a paper-based manual QMS. The choice rests with the contract manufacturer, but the decision should be obvious. By automating a CMO’s quality processes with an electronic QMS that drives quality, compliance can be ensured. The number of manufacturing, business and process management areas that can immediately be improved through an electronic QMS are plentiful. Document Control Contract organizations are conscious of intricacies revolving around handling massive amounts of documentation pertaining to different procedures tracked in the QMS. It gets tedious—and potentially precarious—to maintain copies and binders of documentation when processes are continually going through

recursive updates and reviews. Managing documentation with manual systems makes it difficult for employees to be notified of and educated about the latest changes. The more rogue documents there are floating around, the more likely employees are to get confused about which document version to follow. It can take too much time for a document to be routed to the appropriate personnel for review. By the time the right documentation actually gets approved, employees may have already used an outdated version of the document to perform a procedure or obsolete instructions may have already been implemented throughout different parts of the manufacturing process. Shifting to an electronic QMS helps increase a contract organization’s quality assurance and empowers quality teams by automating task assignments, change control routing, employee notification, tracking, escalations, reviews, and approvals of all documentbased processes. Having automated controls that can be managed with an electronic QMS dramatically simplifies compliance, change management and the implementation of revised controls while also mitigating risk. Corrective and Preventive Action System In 2016, the number one reason the FDA issued warning letters to companies was due to the failure of their corrective and preventive action (CAPA) programs. CAPA programs are the efforts dedicated to the investigation and correction of quality issues in order to prevent recurrence. Regulatory inspectors and ISO auditors consider them to be absolutely critical in the building, management and maintenance of a risk-managed and compliant manufacturing environment. When implemented properly, a sound CAPA program improves product quality and safety, increases customer satisfaction, and more importantly, ensures compliance. Many companies Pharma Bio World

opt for paper-based and hybrid corrective action programs because they initially entail lower up-front costs. However, paper-based systems are inherently inefficient due to the fact that routing CAPA tasks and other related documentation requires an excessive number of man-hours. Such systems also involve a great deal of time devoted to obtaining approvals and signatures. Even performing manual searches and retrieving documents during inspections and audits may prove to be impossible when hard copies of documents are divided amongst different systems and locations. Basically, manual management of CAPA activity leads to an increased number of mistakes, more incomplete actions and an inability to dynamically access critical data. Automating a CAPA system will help organizations properly manage the transfer of information. The right system should be web-based, enabling access to customers, vendors, and other authorized external users. This will allow customer complaints or other potentially CAPA-related forms to be properly tagged, routed, reviewed and managed. Change Control When a change is required for compliance or an improvement to a process, companies will lose business if they lack the ability to execute changes as seamlessly and with as much fluidity as possible. Incorporating changes manually at various levels across an organization exposes the organization and its staff to potential failures throughout multiple departments. When these tasks are automated, it reduces cycle times significantly and improves efficiencies in identifying less critical changes, while also documenting an audit trail for all changes. Avoiding external audits due to improper CAPAs and change control Pharma Bio World

issues is an immediate benefit of using an electronic QMS. Quality Audit Management The quality audit process is the means by which original and contract organizations evaluate various departments, employees, documentation and business processes to validate and ensure a risk-mitigated and compliant system. Through auditing, companies can identify weaker areas and concentrate on the improvement of respective processes. Contract organizations that schedule audits on a consistently recurring basis are better positioned to improve the overall efficiency of the QMS and consequently increase business. With an electronic QMS, the automated scheduling of all recurring audit-related activities helps ensure that all departments are aware of the timelines and expectations of audits and that those audits are properly timed and executed without failure. Facilitating and scheduling audit activities with a paper-based QMS system can be a timeconsuming process that inevitably suffers from impediments to critical audit specific activities and untimely implementation of change control actions. Audits arenâ&#x20AC;&#x2122;t always internally based. They can also be driven by the regulatory bodies, customers or the organizationâ&#x20AC;&#x2122;s vendors or suppliers. It is almost impossible for a third party to implement a proper audit properly or in a timely manner when all records and information is locked in a (potentially geographically dispersed) paper-based system.

From creating a competitive operation to maintaining regulatory compliance, an electronic QMS provides a foundation that allows companies to properly and quickly manage quality issues, whilst ensuring that time, effort and resources are focused on continued growth and success. A paper-based QMS is too error prone and inevitably receives increased scrutiny from regulatory bodies that determine whether or not a company is properly managing its quality processes in accordance with established requirements.

Sources: Mezher M, New FDA Warning Letter, Form 483 for Two Indian Companies. Raps.org, May 2, 2017, http://raps.org/RegulatoryFocus/News/2017/05/02/27463/NewFDA-Warning-Letter-Form-483-for-TwoIndian-Companies/ FDA, CY2016 Annual FDA Medical Device Quality System Data Inspections: FDA Form 483 Observations, and Warning Letter Citations, https://www.fda.gov/ downloads /AboutFDA/Ce n te r s Offic e s / O ff i c e o f M e d i c a l P r o d u c t s a n d To b a c c o / CDRH/CDRHTransparency/UCM554548.

Conclusion As contract organizations evolve and regulations continue to change, perceptive company leaders have little choice but to be more proactive in implementing systems that improve efficiency and facilitate compliance. One of those systems should be an electronic QMS.

Contact: tim.rush@sb5pr.com December 2017 ď&#x201A;&#x201E; 33

Doctor’s Perspective

The Evolving Treatment and Rehabilitation for Spinal Injury Patients

he 17 th edition of the International Spine and Spinal Injuries Conference (ISSICON) that was organized at Le Meridien witnessed participation of doctors, medical experts, and researchers from around the globe. Nearly 72 national and 34 distinguished international faculties became a part of the three-day conference which is organized every year by India Spinal Injuries Center (ISIC) in collaboration with the Spinal Cord Society in an effort to bridge the gap in professional development opportunities for health professionals involved in Spinal Cord Injury (SCI) management. Joining Dr. P. S. Ramani, Mumbai, and Dr. S. K.Srivastava, Delhi, and other leading Indian participants were Dr Stephen Muldoon, Ireland; Dr Fin Biering-Sørensen, Denmark, Dr Ronald K. Reeves, United States, Dr Sait Naderi, Turkey, Dr. Amiram Catz, United States, and other members of international faculty at ISSICON 2017. Many international faculty members were felicitated in the inauguration ceremony of the event.

Dr H S Chhabra Secretary, Spinal Cord Society Medical Director, India Spinal Injuries Center 34  December 2017

The theme of this year ’s conference is Challenges and Opportunities, as the experts discussed the numerous challenges faced in the comprehensive management of spinal cord injury patients in India and other low and middle income countries. Also, the strengths and opportunities of the society which help overcome many challenges were discussed. The strengths include strong support from family, spouse, and community, strong religious beliefs including the doctrine of karma, innovativeness and the relatively

cheap as well as abundant manpower. ISIC and the spinal trauma community worldwide have been focusing on rehabilitating the spinal injury patients and integrating them back to active workforce to boost their confidence and make them economically stable. It also positively impacts the national economy. Growing incidence of the spinal injury cases due to human negligence has become a serious cause for concern and the need to ramp-up the healthcare facilities and staff to meet this growing challenge across the country needs to be recognized. Reintegrating spinal injury patients into mainstream workforce remains a major challenge in India and other low income countries due to factors such as lack of quality rehabilitation facilities, delayed presentation of injury as well as absence of impactful assistive technology, as were agreed by leading experts attending the major international conference on spinal trauma. Human negligence and ignored infrastructure are becoming key factors causing falls and slips which lead to severe injuries. Dr. Fin Biering-Sørensen, former President, International Spinal Cord Society, expressed that in developed countries like Denmark, the aging population suffers most spinal injuries due to simple slips and falls. Also, as people have internalized road safety measures and even use seatbelts in rear seats while driving, spinal cord injuries are witnessed more in two-wheeler and bicycle riders. In comparison, Dr. A. K. Mukherjee remarked India continues Pharma Bio World

Doctor’s Perspective to witness high spinal injuries due to vehicular accidents. Also, Indians need to be alert about its aging population. By 2030, India is expected to have 15% of spinal cases in old people. Vehicular accidents and specially those involving two-wheelers accounts for a majority of spinal injuries in India. Also, around 40% of spinal injuries happen to people in the age-group of 20 to 40. Unfortunately, shortage of quality rehabilitation services and lack of focus on reinstilling confidence among patients make reintegration of patients a major challenge in India. In a case, a 26-year-old girl Karishma suffered severe spinal injuries that restricted her to wheelchair. She suffered these injuries due to a fall from a weak balcony railing of a Goa hotel room where she had checkedin during a holiday trip. Only after aggressive treatment and rehabilitative measures were we able to provide her the independence that she has now. She operates using her wheelchair and has been working for some time now. However, the important aspect of the case is that this was avoidable if there had been no negligence in maintenance of hotel infrastructure. In another case of aggressive rehabilitation reviving a severely injured patient, doctors pointed out the story of a poor laborer, Anil Kumar, who broke his spine when he received a shock from a live wire and fell from the third floor. He lost power in his both legs and control of passing urine and stool. After surgery at ISIC and a course of dedicated rehabilitation, he is now wheelchair bound. However, he has not only returned to work and does all activities of daily living but also is a member of wheelchair basketball team. Pharma Bio World

He recently became father for the first time and fulfils responsibilities there as well. Comprehensive rehabilitation remains the key to recovery of a spinal injury patient. This involves multiple therapies from physiotherapy, occupational therapy, psychosocial counseling, peer-counseling as well as creating appropriate assistive technology to help the patient lead independent and active lifestyles. We need to put greater thrust on these aspects to help patients get back to fruitful work lives ‘Care for the caregivers’ — with this humble motto ISIC spinal trauma experts highlighted the need of building self-efficacy and emotional intelligence amongst the affected and their families. Dr Susan Charlifue from Craig Hospital, United States, elaborated further on how in some cases spinal cord injuries have resulted in strengthening of family bond, whereas in other cases emotional stress have led to divorces. The importance of building resilience and the need for education and maintaining income for the victims was emphasized by Dr Shashi Bhushan, consultant physiotherapist at ISIC. Alongside technological innovations, ISIC also underlined the stringent need for treatment through “positive psychology”. Further measures to make India more disabled-friendly were discussed by expert faculties from over 14 countries at the conference.

While calling for proper awareness amongst people, professionals, and policy makers, doctors also cautioned against unethical and unregulated practices for treatment of spinal injuries. While other treatment options such as stem-cell therapies are in experimental stage, it is too early to undergo treatment using those therapies, which might have adverse effects. Doctors advised patients that only comprehensive rehabilitation is the only way for recovery and no present technology can guarantee complete recovery. However, studies have shown that 55% of paraplegic patients are known to have returned to active workforce. The experts focused on the need for providing spinal cord injury (SCI) survivors with better rehabilitative care and treatments options. Various initiatives for penetration of best available technology and post-surgery rehabilitative and therapeutic care and easy accessibility of loans to try and make treatment reach a larger section of the country were stressed upon at the conference. The India Spinal Injuries Center continues to work with spinal experts from around the world to build a safer, inclusive India.

Other than discussing various advancements in treatment and rehabilitative care, this conference also focused on means that can be employed on a national level in reaching out to maximum people with affordable treatment facilities, which will further contribute to the building of an inclusive India. December 2017  35

marketing initiative

B&R integrates vision into machine automation Automation specialist introduces image processing solution

&R makes an integral

machine vision element of the

automation ecosystem. At this

year’s SPS IPC Drives, B&R introduced the

world’s

first

image

processing

solution to be seamlessly incorporated in the automation system. The solution comprises cameras, software and lighting accessories. At the heart of the solution is a broad selection of intelligent camera technology. Options at the lower end will replace simple machine vision sensors, while the top of the range will harness the full potential of highend smart cameras. Ready-made

software components are available for creating applications with minimal new programming. Intelligent lighting Lighting elements are available integrated in the camera, as an external device, or even as a combination of the two. Extremely precise synchronization for high-speed image capture and object-specific functions such as bright-field or darkfield illumination are easy to implement. Image triggers and lighting control can be synchronized with the rest of the automation system in hard real time and with sub-microsecond precision.

B&R’s machine vision portfolio ranges from simple vision sensors to high-end smart cameras. 36  December 2017

B&R’s machine vision system is integrated on every level: the engineering tool, the real-time operating sys-tem and the application software. With a single development environment for every aspect of automation, controls engineers will now be able to implement many machine vision tasks on their own. About B&R B&R is an innovative automation company with headquarters in Austria and offices all around the world. On July 6, 2017, B&R became a business unit of the ABB Group. As a global leader in industrial automation, B&R combines state-of-the-art technology with advanced engineering to provide customers in virtually every industry with complete solutions for machine and factory automation, motion control, HMI and integrated safety technology. With Industrial IoT communication standards like OPC UA, POWERLINK and openSAFETY as well as the powerful Automation Studio software development environment, B&R is constantly redefining the future of automation engineering. The innovative spirit that keeps B&R at the forefront of industrial automation is driven by a commitment to simplifying processes and exceeding customer expectations. For details contact: Corporate Communications t +43 7748 6586-0 press@br-automation.com B&R Industrial Automation B&R Strasse 1, 5142 Eggelsberg, Austria www.br-automation.com. Pharma Bio World

marketing initiative

Batch-of-one flexibility meets mass-production efficiency New transport system boosts overall equipment effectiveness (OEE)

t the SPS IPC Drives exhibition in Highly dynamic and flexible Nuremberg, B&R unveiled its new intelligent transport system: ACO- ACOPOStrak’s absolute design flexibility POStrak. ACOPOStrak is the first system in allows it to morph into all types of open the world to extend the economies of mass and closed layouts by arranging different combinations of track segments. The production down to batches of one. system is capable of 5 g acceleration and reaches top speeds in excess of 4 meters Divide and merge product flows per second with a minimum product pitch The purely electromagnetic ACOPOStrak of only 50 millimeters. These performance diverters divide and merge product flows numbers, together with the benefits of the at full production speed. Among their many diverters and the extreme design flexibility, advantages is the ability to include a pit lane form a total package like the market has in the track layout. New shuttles are mount- never seen. ed on the pit lane and then channeled onto the track’s actual production lines via a diverter. In the same way, any shuttles that About B&R are no longer needed can simply be rerouted to the pit lane. All of this takes place at full B&R is an innovative automation company production speed. “It becomes possible with headquarters in Austria and offices all to perform product changeover with zero around the world. On July 6, 2017, B&R downtime,” explained B&R’s mechatronics became a business unit of the ABB Group. manager Robert Kickinger at the spectacular As a global leader in industrial automation, unveiling event that kicked off the exhibi-tion. B&R combines state-of-the-art technology

with advanced engineering to provide customers in virtually every industry with complete solutions for machine and factory automation, motion control, HMI and integrated safety technology. With Industrial IoT communication standards like OPC UA, POWERLINK and openSAFETY as well as the powerful Automation Studio software development environment, B&R is constantly redefining the future of automation engineering. The innovative spirit that keeps B&R at the forefront of industrial automation is driven by a commitment to simplifying processes and exceeding customer expectations. For details contact: Corporate Communications t +43 7748 6586-0 press@br-automation.com B&R Industrial Automation B&R Strasse 1, 5142 Eggelsberg, Austria www.br-automation.com.

To switch products, the operator simply places the wheels of a new shuttle on the guides of the pit lane, while production continues at full speed on the rest of the track. Pharma Bio World

December 2017  37

marketing initiative

Improved dosing applications using Coriolis instruments with CORI-FILL™ technology

ow to overcome the disadvantages of using weighing scales? How to shorten production time whilst improving the quality of the final product? The integration of (mini) CORI-FLOW™ instruments in your production line offers unprecedented improvement to process efficiency.

In contrast to the gravimetric method (weighing scales),multiple fluids can be dosed simultaneously. Further more the scales need to be re-zeroed when switching from one fluid to another, whereas instruments with CORI-FILL™ technology just require a short reset command to start the next batch. The amount to be dosed CORI-FILL™ technology features an integrated can be easily preset by programming the batch counter function together with the facility batch counter via a field bus connection. to directly control shut-off valves, proportional This batching method is faster and more valves or (gear) pumps. Due to this technology, compact than the gravimetric method, and Cori-Tech can offer compact assemblies of highly accurate. (mini) CORI-FLOW™ instruments combined with a valve or pump, capable of dosing the As a result of their small footprint it is exact desired amount of fluid. possible to mount the (mini) CORI-FLOW™

instruments directly to the shut-off valves, thereby minimizing the internal volume, resulting in a fast response time and the highest accuracy (minimum delay-effects in the piping). Benefits ●●

●●

●● ●●

●●

Reduced production time due to simultaneous dosing of compounds. Improved product quality due to less evaporation of volatile fluids. Compact solution due to small footprint, without extended tubing between flow meter and valve or pump. Reduced risk of gas inclusion that can cause delay effects. High accuracy due to Coriolis technique and compact assembly. Automatic overrun correction. Fast response times (to less than 0.5 sec.). Mass and volume dosage possible (using density information). Less overhead for PLC/operating system thanks to CORI-FILL™ technology using integrated batch counter and direct actuator control.

Markets Pharma, chemical, food & beverage Applications Dosage of additives, fragrances, flavors, colorants, H2O2 (for sterilization) in continuous or batch blending processes. For details contact Toshniwal Hyvac Pvt Ltd 267,kilpauk Garden Road Chennai - 600010 Ph no : + 91 44 26445626 /8983 Email : sales@toshniwal.net Website : www.toshniwal.net 38  December 2017

Pharma Bio World

marketing initiative

Innovative Vacuum Solutions in Pharmaceutical Industry: The Right Solution from Toshniwal

acuum pumps and systems are common place across a tremendous range of industries. Once the essential principles are understood, the possibilities for application become apparent.

In order to properly select a vacuum system, the principles of basic vacuum technology should be understood. Once the application is clearly defined, a solution can be found by applying these methods. Since we understand and can relate to atmospheric pressure, it is chosen as a reference point. Vacuum is simply a pressure that exists below atmospheric pressure.

non-condensable and condensables, then the choices will be limited. Therefore a right solution considering the load of condensable and ultimate vacuum should be struck. System selection

To select the best type of system for a particular application, the following list needs to be considered. Once it is determined which criteria is the most important from the list, then the vacuum pump that best meets this can be selected. ●● Operating cost ●● Solvent recovery ●● Effect on process To create a vacuum in a vessel, a vacuum ●● Materials of construction producing device needs to remove mass from ●● Operating range it. The more mass that is removed, the lower ●● Reliability the pressure that exists inside the vessel. ●● Waste generation This is why it is important to understand what ●● Pollution abatement vacuum is and how to select the right type of ●● Emission reduction equipment. It is very important to size vacuum ●● Maintenance cost piping correctly to minimize pressure loss. ●● Ease of cleaning The greater the pressure loss, the larger the ●● Serviceability vacuum equipment needs to be. ●● Purchase price The type, quantity of gas handled, and the operating pressure, normally defines what vacuum pump can be used. If the gas consists of mainly non-condensable, then most types of pumps can be used. If the gas consists of

Pharmaceutical and Chemical Industry The pharmaceutical and specialty chemical industries use vacuum for distillation and drying. Various types of dryers are used to

purify products under vacuum. The chemicals are precisely mixed and then heat is applied in the dryer to evaporate the excess chemicals. This is done under vacuum for purer end products; reduce the amount of heat energy required for drying, and also to recover any of the solvents evaporated off thereby not affecting thermally sensitive products. Pumps that are reliable and easy to service in the field are the most important for this industry. If an unreliable pump is tried and it fails in the middle of a drying cycle, then the product is not useable and profit is lost. A typical setup used for this application is: Combining mechanical roots blower along with oil lubricated vacuum pump.

●●

This kind of setup is used to minimize utility costs, drying cycle time and contamination. A properly designed process condenser between your vacuum process and vacuum producing system will yield significant advantages. A process vacuum condenser can significantly reduce the size of the vacuum producing system, recover for reuse valuable product carried from your process with noncondensable gases, reduce amount of wastes produced by the vacuum system, and lower the operating cost of your process. Matching a vacuum condenser with the vacuum producing equipment is the best way to meet the objectives of your process. Toshniwal manufactures both the process condenser and the vacuum producing equipment. This single-source responsibility provides you with a unitized system matched to your process. For details contact Toshniwal Instruments(Madras) Pvt Ltd 267,Kilpauk Garden Road Chennai - 600010 Contact: +91 4426445626 / 8983 Email: sales@toshniwal.net Website : www.toshniwal.n et

Pharma Bio World

December 2017  39

press release Unichem Completes Sale and Transfer of Domestic Formulations Business to Torrent Pharma Unichem Laboratories Limited (Unichem) has completed the sale and transfer of its domestic formulations business in India and Nepal, on a going concern basis by way of slump sale, to Torrent Pharmaceuticals Limited (TPL). Going ahead Unichem will focus attention on all aspects of the international business including finished formulations, API, contract manufacturing and contract research; increase its investments in R&D in the New Chemical and Biological Entities (NCE & NBE), Bio-similars and complex generics; and reward shareholders Mr. Jayendra Shah, played a pivotal role in successful consummation of the transaction. He was the sole financial advisor to Unichem on negotiations, valuations and deal closure. N A Shah Associates LLP, Chartered Accountants were the advisors for tax and related matters and Trans Continental Capital Advisors Pvt. Ltd. were the strategic advisors

Hurun Names Biocon’s Kiran Mazumdar Shaw As the Most Respected Entrepreneur in 2017 The most coveted awards in individual excellence for India Inc., set up by Hurun Report was held with much fanfare at Four Seasons Hotel in Worli, Mumbai on 14th December 2017. Kiran Mazumdar-Shaw, chairman of Biocon and Rana Kapoor, CEO of Yes Bank were named as the 2017 Most Respected Entrepreneurs of the Year for their role in the growth of their individual business, job creation, philanthropy, and overall contribution to the development of the nation. The other coveted awards were received by Jitendra Virwani, Chairman and MD, Embassy Group, who is named 2017 Impact Entrepreneur of the Year, and Arokiaswamy Velumani, MD of Thyrocare Technologies Ltd. as 2017 Self-Made Entrepreneur of the Year. Five billionaires won 2017 Industry Achievement Awards for their contribution in their respective sectors. They are Anant Goenka, MD of CEAT Ltd., for manufacturing (tyres), Ajit Isaac, Chairman of the Board of Directors of Quess Corp, for Services, Arun Chittilappilly, MD of Wonderla Holidays Ltd for Amusement Parks and Dr. GSK Velu, Chairman & MD, Trivitron Healthcare Group of Companies, for Medical Technology. Kiran Mazumdar-Shaw was the only self-made woman billionaire entrepreneur from India in the Hurun India Rich List 2017. She has grown her business by 200% in the last one year alone. Rana Kapoor on the other hand has been recognised for the innovation in the financial sector in India. The Impact Entrepreneur Award is given to Jitendra Virwani who has not only grown his business of innovative co-working spaces but has significant achievements in philanthropy by adopting 36 schools in Bangalore. 40  December 2017

Hurun Awards are given to individuals who have made significant contributions to the economy. The awards are bestowed after careful data gathering and qualitative research of India’s richest individuals. The Hurun Most Respected Entrepreneur Award was first established in 1999. This annual award focusses on two growing economies China and India. The Award is set up to recognise the success stories of entrepreneurs and talk about their stories on a global platform. The London based Hurun Report has been recognising the contributions made by entrepreneurs towards nation building by creating more jobs, build big businesses and engaging in philanthropy. Hurun Awards is one of the most objective awards for individual achievement in wealth creation and nation building. The jury for the Hurun Awards consists of members from Hurun India and China teams, top entrepreneurs from India and UK, members from the Hurun India Rich List, and also senior economists who track India and China.

Piramal Enterprises Acquires Digeplex and Associated Brands Piramal Enterprises’ Consumer Products Division announces the acquisition of Digeplex and associated brands from Shreya Lifesciences. This acquisition strengthens Piramal’s position in the Gastro-Intestinal (GI) segment and is complementary to its existing brands - Polycrol and Naturolax, in the GI segment. These brands hold rich legacy amongst consumers across India. Nandini Piramal, Executive Director, Piramal Enterprises said, “Our aim is to be a significant player in every business under the Healthcare vertical of Piramal Enterprises Limited. Acquisition is one of the important routes to help us achieve our goal and in the last 2 years, we have completed three acquisitions in the Consumer Products business, itself. We believe Digeplex and its associated brands, are a strategic fit for our product portfolio that will help us move closer towards our stated objective. The combination of organically growing our existing core brands and strategically acquiring accretive brands, has helped us create a powerful portfolio of OTC brands in India.” Kedar Rajadnye, COO - Consumer Products Division, Piramal Enterprises said, “Today’s consumers lead a fast and hectic lifestyle, which coupled with stress and infrequent food habits, tends to take a toll on their digestive wellbeing. As per AIOCD October 2017 data, the Gastro Intestinal market in India, which addresses the constipation, diarrhoea and appetite stimulant categories, is a ~INR 13,000 Crore market and has grown at ~11% y-o-y. We already have a well-established antacid brand – Polycrol, and Naturolax, an isabgol husk based brand which helps in treating constipation. With these additions, our basket of offerings in the Gastro Intestinal market will become larger. We expect these brands to leverage the strong sales and distribution capability that we have built over the years and help us improve our profit margins. This brand has a huge potential to become a power brand in its category.” Pharma Bio World

press release MedGenome Receives Accreditation from CAP MedGenome, India’s market leader in genetic diagnostics has announced that its NGS (Next Generation Sequencing) technology based clinical laboratory in Bangalore has been awarded accreditation from the College of American Pathologists (CAP) based on the results of an onsite inspection. The CAP Laboratory Accreditation Program is a globally recognized program and is the only one of its kind that utilizes teams of practicing laboratory professionals as inspectors. and is designed to go well beyond regulatory compliance. During the accreditation process, inspectors do a detailed check of the laboratory’s records and quality control procedures. They also assess the laboratory’s staff competency/qualifications, equipment, facilities, safety program, and overall management to ensure it meets CAP’s broad and stringent quality criteria. This accreditation is awarded to facilities meeting the highest standard of excellence in clinical laboratory practices. With this accreditation, MedGenome’s India laboratory joins the ranks of the most elite laboratories in the world. “Being awarded the accreditation by CAP is an extremely proud moment for us. It further validates our commitment to provide the highest standards in quality laboratory services” said Dr. V.L Ramprasad, COO MedGenome. “Having launched India’s first validated Liquid biopsy and the carrier screening tests, we are trying to find answers to some of the most complex diseases. We strive to provide the most accurate results based on thorough and rigorous processes to clinicians across India, so that they can produce the best outcomes for patients”.

rapid growth, with a CAGR of 17.6%. As we congregated for this elite knowledge sharing session, we confronted the Indian pharma industry at a very crucial juncture in its growth trajectory. While India ranks amongst the top four pharmaceutical markets in terms of volume of produced drugs, certain challenges continue to surround its pharma industry. India faces issues including a time-consuming approval process, dependence on China for cheaper API sources, sub-optimal infrastructure, lack of funding avenues, and a shortage of highly skilled talent, among others. “ The best-in-class industry professionals who were a part of the exclusive meeting included D G Shah, Secretary General, Indian Pharmaceutical Alliance; Dinesh Dua, CEO & Director, Nector Lifesciences; S V Veeramani, Chairman & MD, Fourrts (India) Laboratories Pvt Ltd; Prashant Nagre, CEO, Fermenta Biotach; Ranga Iyer, Former MD, Wyeth; Rajiv Gulati, Former President, Ranbaxy; Suresh Subramanium, Senior VP & Head, Branded Formulations, South Asia; Ashok Bhattacharya, Executive Director/ Country Manager, Takeda Pharmaceuticals India Pvt Ltd; Prof. Pierre Pienaar, President, WPO; Dev Prakash Yadava, Managing Director , Shardachem; Dr. G.M. Warke, Founder & CMD HiMedia Laboratories; A. Vaidheesh, MD, GSK; Ziva Abraham, CEO, Microrite Inc; Srinivas Lanka, Vice Chairman Pharma and Bio Taskforce, Andhra Pradesh Economic Development Board; Kewal Handa, Director, Salus Lifesciences; B.G. Barve, Joint Managing Director, Bluecross Laboratories Pvt Ltd; S M Mudda, Director Global Strategy, Microlabs and Mr Yogesh Mudras, Managing Director, UBM India. A representative body of the group comprising Kewal Handa, Dr. Dinesh Dua, Sriram Shrinivasan, S.M. Mudda and Yogesh Mudras later interacted with the media to discuss the key tenets of its proposals.

With this accreditation, MedGenome is the only Indian laboratory to be CAP accredited for Whole genome/exome sequencing, CfDNA (Cell free DNA) testing for liquid biopsy and NIPT (Non-invasive prenatal screening test) and high resolution HLA typing.

Cadila Pharma Organised Walk-a-thon to Raise Awareness on AIDS

A Turnkey Meeting to Add Fillip to India’s Pre-eminent Position in Pharma Domain

On the occasion of World AIDS Day, the employees of Cadila Pharmaceuticals Ltd took a ‘Step to Stop AIDS’ by participating in an AIDS Walk-a-thon organised on Friday, December 1, 2017. The aim of the walk-a-thon was to raise awareness about AIDS and also to open a dialogue for discussion.

The 2nd edition of the celebrated India Pharma Week, a UBM India initiative -- introduced last year to celebrate a decade of CPhI & P-MEC, UBM’s flagship engagement platform, and the world’s leading Pharmaceutical networking event -- witnessed one of its most significant events, the CEO Round Table. The exclusive, closed-door Round Table was a congregation of India’s most influential CEOs, Presidents & Founders from leading pharmaceutical companies, and Policy Makers & Senior Representatives from Pharmaceutical Associations who engaged with one another on the vital issue of Make in India – Ensuring India’s Pharma Supremacy with a special focus on affordable healthcare in the urban and rural areas in India. Speaking on the occasion of the CEO Round Table, Mr. Yogesh Mudras, Managing Director, UBM India said, “Renowned as the pharmacy hub of the world, the Indian pharma economy has been lauded for its Pharma Bio World

The walk-a-thon was flagged off at ISKCON and saw the enthusiastic participation of the company’s employees. Dressed in blue and white, over 150 employees marched to Prahladnagar raising slogans and banners to throw spotlight on AIDS prevention. Several key messages about this pandemic disease were highlighted as well as archaic, discriminatory myths were busted. Slogans such as “START TALKING, STOP HIV”, “SILENCE=DEATH”, “Kissing and Hugging doesn’t spread HIV” were carried by the participants. Adding further fervour to this walkathon were the members of the Avengers Biker Club of Ahmedabad who had specially escorted the participants throughout their stride. At the end of the walk the participants gathered together in a group and took an oath to remain committed to fight the battle against AIDS by continuing to spread awareness on the disease. December 2017  41

press release First ‘South Asian and Indian Ancestry Genetic Test’ Xcode, an innovative personal genomics company based out of Chennai was in the city, has announced the Worldwide launch of the first of its kind ‘South Asian Ancestry Genetic Test’ that will trace one’s ancestry in the global and South Asian sub-population level. The test will reveal information about oneself comparing the DNA samples of each individual with more than 35 ethnic groups in India, Pakistan, Nepal, Bangladesh and other regional countries to provide a detailed ancestry break-up. Talking on this Occasion, Dr. Abdur Rub, Co-Founder and Chief Technology Officer, Xcode Life Sciences said - “Our unique heritage, our unique history, the history of our ancestors, is living within each of us! You may be 20, 30 or 50 years old, but your genes are 3 billion years old. For the first time in human history, genetic technology makes it possible to uncover this unique past that each of us carry in us. I am very excited that Xcode is launching world’s first ‘South Asian Ancestry Genetic Test’ through which your DNA is matched with more than 35 ethnic groups in India and other groups worldwide, and your most recent paternal ancestor”. Present at the launch to to spread awareness on using genomics to deduce Indian ancestry was Dr. Analabha Basu, Associate Professor, National Institute of Biomedical Genomics. Sharing his views on the subject, he said, “Knowledge about the origin of the human species as a whole has the potential to reshape our society. The more we learn about our diversity, the more we learn how connected we are. It can lead to path-breaking medical discoveries and pave the way forward to research based on our DNA patterns.” Xcode will also help individuals to trace their paternal ancestry by evaluating your DNA which will decode ancient migratory patterns of their forefathers. Tracing our family tree is an activity that features in all our childhoods, but did any of us manage to reach beyond our grandparents or our great grandparents? All of us are products of generations of ancestry with a rich history and heritage, all embedded in our genes waiting to be uncovered. Every cell in our body contains DNA which can reveal everything from our family history to our ancestral migratory patterns and with Xcode’s innovative DNA ancestry test, you now have the chance to unravel this rich history written in your DNA.

SCHOTT KAISHA Introduces Path Breaking Pharma Packaging Innovation SCHOTT KAISHA has introduced state-of-the art technologies and pathbreaking innovations in the pharmaceutical primary packaging space. With its advanced operational capabilities, SCHOTT KAISHA was the first manufacturer of glass syringes and cartridges in India, and continues to be a prime supplier for drug producers. “With our commitment to establish India as a leading export hub, we are a perfect success story of India’s ‘Make in India’ and Germany’s ‘Industry 4.0’ for automation in manufacturing technologies. For us, meeting and exceling in international standards is just a matter of fact but not the end goal. We want to raise the bar higher and set standards which others will follow,” said Rishad Dadachanji, Director, SCHOTT KAISHA. 42  December 2017

Going into its second decade of joint venture operations in India next year, SCHOTT KAISHA has announced the opening of a second production module at its manufacturing plant in Jambusar, Gujarat to keep up with the rising market demand. The expanded module will increase the existing production capacity by almost 50 % and will be running in full capacity by the end of 2018, enabling SCHOTT KAISHA to cross 3 billion containers produced per annum. Besides expanding its industrial footprint, SCHOTT KAISHA has continuously invested in research and development. With the recently launched new opto-electronic inspection systems for vials, a 100% cosmetic inspection of the entire vial from 5 different cameras has been achieved for the first time. The company is not only offering a standard inspection protocol with this system, but also various customization avenues, based on the evolving customer requirements. “We take pride in not just running our manufacturing plants as per the international standards, but also in becoming pioneers in introducing best practices in the Indian pharmaceutical packaging space. Our new offering is a classic example, being one of the most advanced cosmetic inspection systems as it covers 100% of the entire vial”, Rishad shared. SCHOTT KAISHA has also introduced SCHOTT’s iQ™ platform in India, providing a versatile portfolio of Ready To Use (RTU) pre-fillable syringes - syriQ®, vials - adaptiQ®, as well as cartridges - cartriQ™. With the iQ™ platform, these RTU containers are packed in a nest inside an industry-standard tub, permitting smooth integration into existing syringe filling lines or new flexible filling lines. This not only enables a considerable reduction in the overall Time to Market, but also helps reducing investments by up to 40%, clean room space by up to 60%, and running costs by up to 40%.

Mylan Launches Biosimilar Bevacizumab in India Mylan Pharmaceuticals Private Limited has announced the launch of ABEVMY (Injection Bevacizumab 100 mg and 400 mg), an anti-angiogenic drug approved by the Drug Controller General of India (DCGI) for all indications of the Roche’s Avastin, including for the treatment of metastatic colorectal, non-small-cell lung carcinoma, glioblastoma, ovarian, cervical and renal cancer as part of specific regimens for Indian patients. The approval of ABEVMY was supported by a comprehensive data package to prove biosimilarity including robust analytical, pharmacokinetic, and pharmacodynamic studies and an India-specific, randomized, doubleblind clinical trial in metastatic colorectal cancer patients. ABEVMY is a recombinant “humanized” monoclonal antibody that selectively binds to human vascular endothelial growth factor (VEGF) and neutralizes its biologic activity. Bevacizumab inhibits the formation of tumor vasculature, thereby inhibiting tumor growth. An important benefit for patients is its price for each therapy cycle, which is comparatively lower than the existing options. According to data from the Indian Council of Medical Research, 1.45 million new cases of cancer in the country were reported in 2016. This figure is estimated to increase by approximately 1.73 million new cases annually by 2020. Mylan’s oncology portfolio in India includes cytotoxic and targeted oncology therapies for common types of cancer. Pharma Bio World

press release XCODE LIFE Launches the World’s Bill Gates Acknowledges Hester for Developing a Newcastle Disease Vaccine It gives us immense pride to share with you that Mr. Bill Gates mentioned Hester’s name in his speech at AP AgTech Summit 2017 in Visakhapatnam on 17 November 2017. Mr. Gates referred to the Bill & Melinda Gates Foundation’s partnership with Hester in developing a Thermostable Newcastle disease vaccine for the smallholder backyard farmers. Since 1997, Hester has been manufacturing the conventional Newcastle Disease vaccine, which is required to be stored and transported under a cold chain between 2 to 8 degrees Celsius. Facilitating mass access to the Newcastle Disease Vaccine in rural backyard poultry farms was therefore always a challenge due to the inability to maintain the cold chain up to the end user of the vaccine. In 2014, Hester developed a Thermostable Newcastle disease vaccine that withstands a temperature up to 40 degrees Celsius for a few days. This vaccine was developed in collaboration with Galvmed, an international NGO having its head office in Edinburgh, Scotland, funded by the Gates Foundation. This Thermostable Newcastle disease vaccine is being considered as an appropriate solution to the problem of last-mile-service delivery for backyard farms in rural area where cold-chain infrastructure is available in a compromised form.

preparations and high purity is an essential factor. Being pioneers in water treatment, Ion Exchange (India) has always invested in R&D to introduce some of the most innovative and technically advanced products and services to meet the needs of the pharma industry’s stringent and critical requirements. While we have a complete range of high purity water generation and demineralisation products, INDION SWIFT 5Gx offers state-of-the-art technology for producing high purity water consistently for the pharmaceutical and biotechnology sectors. The performance driven product is cost effective, modular, energy efficient and has a very short regeneration time of only 35 minutes. This is sure to improve overall productivity for varied pharmaceutical processes.” INDION SWIFT 5Gx is fully automatic and has minimum bacteria buildup due to its short cycle. The product is also entirely compliant with latest USP & Eur. specifications and with GAMP & ISPE design standards. The INDION range by Ion Exchange is known for complete pure water generation package and is pre-validated to industry accepted standards. Ion Exchange has been a preferred and trusted partner to the pharma sector for water treatment and purification across the world. In addition to high purity water solutions for the pharma and biotech sectors, Ion Exchange is also a specialist in ion exchange resins used for water applications and non-water applications i.e. excipients in pharmaceutical formulations, and polymeric adsorbents. It also offers a complete range of reverse osmosis membranes from its state-of-the-art integrated manufacturing facility in Goa. Other areas of specialization are Zero Liquid Discharge Systems, Raw Water Treatment Systems, Waste Water Treatment and Recycle Systems, and Sewage Treatment Plants. Additionally, it offers ASTOM, Japan’s wide range of Electro Deionisation Reversal/Diffusion Dialysis Membrane & Systems for Separation,

Ion Exchange (India) Limited Launches Avvashya CCI Logistics Commences High Purity Water Generation Product Operations at Bhiwandi Warehouse for the Pharma Industry Industry leaders in water treatment, liquid waste management and environment solutions, Ion Exchange (India) Limited has announces the launch of INDION SWIFT 5Gx – a high purity water generation product catering to the special needs of the pharmaceutical industry. The product has been designed in consultation with pharmaceutical engineers and end users for maximum performance. This launch marks the company’s expansion of its product line for the sector within its ‘INDION’ purified water systems range. 353_SWIFTINDION SWIFT 5Gx improves efficiency and purity by introducing a new and unique technology which uses ‘Uniform Particle Size’ resins instead of the conventional resins otherwise used in water treatment and purification. The new product uses a shortcycle regeneration method and takes up to 35 minutes only in order to regenerate as compared to other available conventional products which have an average time of 8 hours for a single regeneration cycle. The product is a first of its kind for the pharmaceutical sector and with validation package. Launching the product, Mr. Ajay Popat, President, Ion Exchange (India) Limited said, “Water is a primary ingredient for pharmaceutical Pharma Bio World

Avvashya CCI Logistics (ACCI), a subsidiary company of Allcargo Logistics Ltd, has started operations at its new warehouse in Bhiwandi. The state-of-the-art warehouse is located at the Renaissance Logistics Park, WB-09 Bhiwandi. A part of the warehouse, upto 2500 pallet position, is dedicated for Clariant, a multinational specialty chemicals company and rest for other customers. Spread across 1.31 lakh sq ft, the warehouse meets global standards in safety and security compliances. The facility functions on a multi-client mode and has a clear height of 10 meters, with mid height being 11.5 meters and fully racked with a capacity of 10,776 pallet positions. The Bhiwandi warehouse has a geographical advantage as it is located on the proposed junction of Delhi Mumbai industrial freight corridor and Nagpur – Mumbai Industrial corridor thus having the attention of both central and state government for all its projects. The complex is located on the state highway no. 40 which is a proposed 4 lane road in the years to come, and is well connected with close proximity from Kalyan and thane railway stations as well as Kalamboli CFS. This park also falls under the proposed SMART CITY project of the Government and hence gets maximum attention of the MIDC and other government authorities in areas of development. December 2017  43

Pharma News BioMatrix Partners with Genentech BioMatrix SpRx has selected as an authorized specialty p h a r m a c y p r o v i d e r o f G e n e n t e c h ’s n e w d r u g , H e m l i b r a (emicizumab-kxwh). The product is indicated for pediatric and adult patients who have hemophilia A with inhibitors. Receiving Breakthrough Therapy Designation by the FDA in 2015, Hemlibra is the first self-administered, subcutaneous therapy for hemophilia. Data from ongoing clinical studies indicates once weekly injections substantially reduce bleed rates. Chief clinical officer David McCormick shares, “We are thrilled to partner with Genentech to offer Hemlibra. We have a long history of supporting patients with inhibitors and understand the unique challenges this community faces. We have witnessed the quality of life improvements this drug can provide, and are so proud to play our role in helping patients experience better health.” BioMatrix SpRx, a portfolio company of Acon Investments and Triton Pacific Capital Partners, LLC., offers comprehensive nationwide specialty pharmacy services and digital health technology solutions for a range of chronic health conditions.

Kernal Biologics & QurAlis Win Amgen Golden Ticket at LabCentral Amgen and LabCentral have announced that Kernal Biologics and QurAlis have won the Amgen Golden Ticket at LabCentral. The two Golden Ticket winners were chosen by an Amgen internal committee and live audience members at a “Quick Pitch” event hosted by Amgen at its Cambridge R&D and operations facility on December 11, 2017. Five finalists pitched their business plan to attendees where the audiences’ input represented one vote of the overall results, along with the Amgen internal committee’s voting decision. As one of LabCentral’s platinum sponsors, Amgen can nominate up to two early-stage companies annually to take up residence in LabCentral’s Kendall Square facilities in Cambridge, Mass. The Golden Ticket represents one year of bench space for one scientist, including benefit of LabCentral’s shared infrastructure and services (such as conference rooms, permits, shared equipment and facilities, participation in LabCentral training modules and seminars). Amgen scientists also provide informal mentoring. LabCentral is a first-of-its-kind shared laboratory space designed as a launchpad for high-potential life sciences and biotech startups. 44  December 2017

“The event captured the essence of why Amgen is committed to contributing to and collaborating in the Cambridge biotech ecosystem. Not only were we evaluating ideas from five very strong startup companies advancing innovative science right in our own backyard, but we could be joined by our industry colleagues with a diverse set of backgrounds to assess the best innovations to help bring forward,” said John Dunlop, vice president of Neuroscience at Amgen. “Awarding the Golden Tickets to Kernal Biologics Inc. and QurAlis aligns with Amgen’s ongoing research focus within oncology and neuroscience.” Kernal Biologics Inc. develops therapeutic messenger RNAs via deep learning for immuno-oncology applications. Kernal’s unique methods of sequence engineering and smart design are intended to develop a technology platform that will dramatically improve the efficacy of existing mRNA technologies.

Rimidi, Eli Lilly Ink Deal Rimidi, a digital health company that provides software and clinical analytics for chronic disease management, and Eli Lilly and Company, a leader in diabetes care for more than 90 years, are coming together to develop provider-focused tools that will integrate personalized solutions for people who use insulin to manage their diabetes. Rimidi will integrate its diabetes management software platform with Lilly’s integrated insulin management system in development. The non-exclusive agreement between Rimidi and Lilly will strive to make diabetes management easier for approximately 30 million Americans with diabetes and the health care providers who care for them by helping people use insulin more effectively while optimizing diabetes management within the normal clinical workflow. “Diabetes management is a collaborative effort between people with diabetes and their healthcare providers. With the right support they can achieve better results together,” said Lucienne Ide, MD, PhD and chief executive officer of Rimidi. “We are proud to partner with Lilly to facilitate personalized management of diabetes. This is a ‘better together’ story.” Rimidi’s platform helps clinicians personalize care by leveraging the individual characteristics and clinical histories of people with diabetes to identify individuals who may benefit from specific management approaches. Lilly’s integrated insulin management system combines a connected insulin pen with glucose-sensing technologies (e.g., glucose meter, CGM) and software applications to deliver personalized insulin dose recommendations. Data from these devices and apps will flow back to physicians to truly connect care. Pharma Bio World

Pharma News M e d i c u r e A c q u i r e s E x c l u s i v e Pfizer’s Psoriatic arthritis Drugs License to Sell & Market Branded Get US FDA Nod Cardiovascular Drug in US Pfizer has announced that the United States Food and Drug Medicure announced that its subsidiary Medicure International has acquired an exclusive license from a large multinational pharmacompany to sell and market a branded cardiovascular drug for the treatment of patients with primary hyperlipidemia or mixed dyslipidemia, in the United States and its territories. The licensing agreement is for a term of seven years with extensions to the term available. The cardiovascular drug was approved earlier in 2017 by the US Food and Drug Administration (FDA) for sale and marketing in the United States and the Company intends to launch the product using its existing commercial sales force and infrastructure with a target commercial launch date in the first half of 2018. “This licensing agreement, similar to our recent licensing of Prexxartan, fits well with Medicure’s mission of being a significant cardiovascular pharmaceutical company focused on the US market,” commented Medicure’s president and chief executive officer, Dr. Albert D. Friesen. “This will further add to Medicure’s revenue in the near term and utilizes the current commercial infrastructure in place for Aggrastat (tirofiban hydrochloride).”

DKSH India Wins Ashland “Best Channel Partner” Award for Rest of Asia Region DKSH’s Business Unit Performance Materials, a leading ingredients and specialty chemicals distributor and provider of market expansion services, received the “Best Channel Partner” award 2017 for the Rest of Asia region (excluding China) from Ashland India, on behalf of the Ashland Regional Pharma Sales team, on December 1, 2017. The award was presented to DKSH India as a recognition and acknowledgement of DKSH’s achievement for high growth in sales and many successful launches of new Ashland pharma products into the region specifically the launch of functional polymers into new domestic segments. DKSH India provides market expansion services to Ashland India, including nationwide distribution for excipients and functional polymers. DKSH has been a valuable partner and collaborator to ensure that Ashland is always solving. Ashland’s pharmaceutical team prides itself on advancing drug delivery with sophisticated science-based solutions. With its longhistory in pharmaceutical production and one of the widest available product ranges for oral solid-dosage forms, Ashland has a solid foundation to help find excellent excipient and formulation solutions. Pharma Bio World

Administration (FDA) has approved Xeljanz 5 mg twice daily (BID) and Xeljanz XR (tofacitinib) extended release 11 mg once daily (QD) for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs). Xeljanz/Xeljanz XR is the first and only Janus kinase (JAK) inhibitor approved by the FDA for both moderate to severe rheumatoid arthritis (RA) and active PsA.

“Psoriatic arthritis is a complex and progressive disease with an unpredictable course,” said Angela Hwang, global president, inflammation and immunology, Pfizer. “The approval of Xeljanz is an important step forward for patients seeking new treatments and is a testament to Pfizer’s unwavering commitment to advancing patient care.” The recommended dose of Xeljanz/Xeljanz XR is in combination with nonbiologic DMARDs, and use in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. The FDA approval of Xeljanz for the treatment of adult patients with active PsA was based on data from the phase 3 Oral Psoriatic Arthritis Trial (OPAL) clinical development program, which consisted of two pivotal studies, OPAL Broaden and OPAL Beyond, as well as available data from an ongoing longterm extension trial, OPAL Balance. The findings from OPAL Broaden and OPAL Beyond were published in October 2017 in the New England Journal of Medicine.

Gilead Sciences to Appoint John C Martin as New Chairman Gilead Sciences has announced that executive chairman John Martin, PhD will transition from his current role of executive chairman to chairman of the board of directors effective March 9, 2018. Dr. Martin was named Executive Chairman on March 10, 2016, when he was succeeded as CEO by John Milligan, PhD. Dr. Martin served as chief executive officer of Gilead from 1996 to 2016, having joined the company in 1990 as the vice president of research and development. During his time as CEO, he built the company’s portfolio to 24 marketed products with annual revenues of more than USD 32 billion. “John’s scientific and business leadership has been notable for the development of Gilead’s portfolio of HIV and viral hepatitis medicines and commitment to worldwide access for patients. We are all grateful that he will continue to help guide the company as chairman of the board,” said Dr. Milligan, president and chief executive officer of Gilead. December 2017  45

Biotech News Frutarom Acquires AB-Fortis Frutarom Industries Ltd has announced the acquisition, via one of its subsidiaries, of the AB-Fortis activities including a patentprotected micro-encapsulation technology that enables delivery of iron with increased biological absorption. AB-Fortis is an advanced encapsulated iron system for delivering the recommended daily amount of iron in a single dose. It helps consumers avoid the common negative aspects and side effects of iron supplements, including metallic aftertaste, dental darkening, gastrointestinal upset, and nausea. AB-Fortis iron can be incorporated into fat-rich matrices, such as milk or yogurt, without causing oxidation. It is heat- and pH-stable. It will not accelerate oxidation of other components of a formulation, such as folate or omega-3 fatty acids. This makes it ideal for functional foods, infant nutrition and food supplements. Iron deficiency constitutes a global health problem in developed and developing countries alike, and is particularly prevalent in children under the age of 6, for whom iron deficiency is associated with impaired psychomotor and cognitive development, as well as in pregnant women suffering from excess fatigue due to iron deficiency. Among these groups, the percentage of population suffering from iron deficiency reaches 20% in developed countries and up to 60% in some developing countries. Frutarom acquired the technology and expanded its activity in the market after four years of experience developing applications in a wide range of food and beverage products.

Researchers Explore Complex Genetic Network behind Sleep Duration Scientists have identified differences in a group of genes they say might help explain why some people need a lot more sleep than most. The study, conducted using fruit fly populations bred to model natural variations in human sleep patterns, provides new clues to how genes for sleep duration are linked to a wide variety of biological processes. Researchers say a better understanding of these processes could lead to new ways to treat sleep disorders such as insomnia and narcolepsy. Led by scientists with the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, the study will be published on Dec. 14 in PLOS Genetics. “This study is an important step toward solving one of the biggest mysteries in biology: the need to sleep,” says study leader Susan Harbison, Ph.D., an investigator in the Laboratory of Systems Genetics at NHLBI. “The involvement of highly diverse biological processes in sleep duration may help explain why the purpose of sleep has been so elusive.” 46  December 2017

Scientists have known for some time that, in addition to our biological clocks, genes play a key role in sleep and that sleep patterns can vary widely. But the exact genes controlling the duration of sleep and the biological processes that are linked to these genes have remained unclear. To learn more, scientists artificially bred 13 generations of wild fruit flies to produce flies that were either long sleepers (sleeping 18 hours each day) or short sleepers (sleeping three hours each day). The scientists then compared genetic data between the long and short sleepers and identified 126 differences among 80 genes that appear to be associated with sleep duration. They found that these genetic differences were tied to several important developmental and cell signaling pathways. Some of the genes identified have known functions in brain development, as well as roles in learning and memory, the researchers said.

Glenmark’s Phase 3 Safety Study Evaluating Ryaltris in Patients with PAR Meets Primary Endpoint Glenmark Pharmaceuticals, a Rs. 8,950 crore plus pharma major from Mumbai, announced that the company met its primary clinical endpoint in a phase 3 study evaluating the safety of Ryaltris, an investigational fixed-dose combination nasal spray, in perennial allergic rhinitis (PAR). Ryaltris has been conditionally accepted as the brand name for GSP 301 nasal spray by the US Food & Drug Administration (FDA). Glenmark plans to submit the company’s first new drug application (NDA) to the FDA for Ryaltris for the treatment of patients with seasonal allergic rhinitis (SAR) in the first quarter of CY 2018. “Ryaltris has been extensively studied in three phase 3 trials for SAR, and we are pleased that the addition of this long-term study in patients suffering with PAR met the primary safety and secondary efficacy endpoints. Collectively, these data suggest that Ryaltris is effective and well-tolerated,” said Fred Grossman, president and chief medical officer at Glenmark Pharmaceuticals. “We have worked closely with the FDA on the clinical development program for Ryaltris, and look forward to providing robust data to support its potential approval.” This phase 3, US-based trial was a three-arm, double-blind, randomized, parallel group, placebo-controlled safety study that enrolled 601 adults and adolescents 12 years of age and older with at least a two-year history of PAR. Patients were randomized to 52 weeks of twice-daily treatment with Ryaltris, or two different formulations of a placebo nasal spray. All trial arms used the same nasal spray delivery system.

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Biotech News Daiichi Sankyo, Puma Biotech Sign Research Pact with MSK Cancer Centre Daiichi Sankyo Company, Limited and Puma Biotechnology have announced a preclinical research collaboration with Memorial Sloan Kettering Cancer Center (MSK) to explore the combination of Daiichi Sankyo’s investigational antibody drug conjugate DS8201 and Puma Biotechnology’s irreversible pan-HER tyrosine kinase inhibitor neratinib (NERLYNX) in HER2-mutated or HER2-positive solid tumours. A team of scientists led by Maurizio Scaltriti, PhD, and in collaboration with a team of clinical investigators led by Bob Li, MD, will use isogenic models and established patient-derived xenograft models to assess the susceptibility of HER2-mutated or HER2-positive cancers to DS-8201, neratinib and other HER2-targeting therapies, elucidate mechanisms of action and resistance of these various tumour types, and evaluate the potential for synergistic combinations. Daiichi Sankyo and Puma Biotechnology will co-sponsor the research. “Since early clinical data suggest that DS-8201 may have activity beyond breast and gastric cancers, the archetype HER2-driven tumors, we are interested in studying this asset on a molecular level as well as in combination with other HER2targeting agents,” said Tom Held, vice president, Global Head, Antibody Drug Conjugate Task Force, Daiichi Sankyo. “In this collaboration, we are examining whether combining DS-8201 and neratinib, with its specific covalent binding to the HER2 receptor and associated increased internalization, is a rational combination therapy strategy to pursue. We are excited to join forces with Memorial Sloan Kettering and Puma to advance the understanding of combining HER2-targeted therapies to potentially treat various forms of HER2-mutated cancer.”

BIRAC Invites Research Proposals in the Areas of Vaccines, Biotherapeutics The Biotechnology Industry Research Assistance Council (BIRAC) has invited research proposals from biotech companies in the areas of vaccines, biotherapeutics, medical devices & diagnostics under the National Biopharma Mission, which is an industry-academia collaborative mission for accelerating discovery research to early development for biopharmaceuticals named Innovate in India (I3). I3 is a mission of Department of Biotechnology (DBT) in collaboration with World Bank which will be implemented by BIRAC. In the area of vaccine, the focus of this program will be on support for accelerating development of novel vaccine candidates for HPV, dengue and pneumococcal; and novel and complex Pharma Bio World

vaccine candidates for other diseases of high burden and priority in India. In the area of biotherapeutics, the thrust will be on support for development of biosimilars (therapeutic proteins and monoclonal antibodies) for cancer, rheumatoid arthritis and diabetes. Besides, the program will focus on support for establishment of process development laboratory, CMC facility, GLP validation facility and cell line repository. In the areas of medical devices & diagnostics, the focus of this programme will be on support for accelerating development of critical medical device technologies for relevant product segments, and core technologies as platform technologies for priority products. The aim of the mission is to enable and nurture an ecosystem for preparing India’s technological and product development capabilities in biopharmaceutical to a level that will be globally competitive over the next decade, and transform the health standards of India’s population through affordable product development. The program will specifically focus on the development of new vaccines, bio-therapeutics, diagnostics and medical devices to address the rising burden of diseases in the country.

Karnataka Woos Scientists and Entrepreneurs Karnataka government is now going all out to woo scientists and entrepreneurs to set up nano tech ventures. The government sees that the state has already created an ecosystem for nanotechnology. Since Bengaluru is already home to major research centres focusing on nanotechnology for pharma, energy engineering, medicine, energy, transport and communication, it would be the right choice for investors to consider this location, according to Karnataka Minister for Planning, Statistics and Science & Technology, MR Seetharam. Nanotechnology initiatives have taken off in the country at research institutes and academia engaged in concrete efforts along with commercialization of the technology to a certain extent by the industry, he said. At the three-day 9th Bengaluru India Nano which is the country’s flagship event, held from December 7 to 9, 2017, the theme chosen was ‘Nano Horizons’ to discuss about the prospects and possibilities in this emerging field. Besides this event, the government is also providing financial support for various R&D projects and infrastructure developments in the field of nanoscience and nanotechnology for higher education institutions based on the recommendation of Vision Group on Science and Technology (VGST). December 2017  47

Oil-sealed Rotary Vane Pumps R and D Series high vacuum pumps are used when the final absolute pressure required is very low <0.5 mbar (abs). These pumps may run continuously connected to close containers to be emptied and may not run continuously at length, at atmospheric pressure. The exhaust from these pumps is not filtered and thus special purifiers are available for fumes if necessary. The main areas of use include refrigeration and air conditioning systems, laboratory applications, freeze-drying, spectrometry and ultracentrifugation. For more information, please contact: DVP Vacuum Technology srl Via Rubizzano n 627 40018 S Pietro in Casale Bologna, Italy Tel: +39 051 18897101 Fax: +39 051 18897170

Cable Float Switch The cable float level switch is structured from chemical resistant polypropylene. Electrical switching circuit comprises of micro switch and iron ball to control the contact. The switches are operated through an iron ball which enables On or Off contact signal when the floating angle is larger than a certain degree where the state of the iron ball and micro switch will be changed for actuation.It finds application in hydraulic oil, water boilers, chemical and pharma. For more information, please contact:

Filpro Sensors Pvt Ltd No: 130, 10 th Cross, Petechennappa Indl Estate Kamakshipalya, Magadi Main Road Bengaluru, Karnataka 560 079 Tel: 080-23286463 E-mail: sales@filprosensors.com

Process Analyzer The 2035 Process Analyzer comes in three basic configurations for potentiometric, photometric, and thermometric measurements. Any of these can be combined with additional measuring techniques such as pH and/or conductivity measurement.Due to modular architecture of the wet part, there is an analyzer configuration for each specific application challenge. A large array of functional modules such as burettes, pumps, vessels, valves, and more is available. Strict separation of wet part and electronics ensures safe operation in harsh environments. The electronics part is housed within non-corrosive epoxy-coated stainless steel. Metrohm Process Analytics provides virtually any sample pre-conditioning system, such as cooling or heating, pressure reduction, degassing, filtration, and more.Ethernet TCP/IP Network communication and remote operation, web services, MODBUS, analog outputs, digital outputs to transmit results, and alarm status signals. Result export to USB.

For more information, please contact:

Metrohm India Ltd 205/206, Sector III Bldg 5 Millenium Business Park Mahape, Navi Mumbai 400 710 Tel: 022-27781003, 27781026, 27781027 Fax: 91-022-27781028 E-mail: joy@metrohm.in

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Oil-lubricated Vacuum Pumps Toshniwal supplies oil-lubricated vacuum pumps. This oil-lubricated vacuum pumps of the TMS Series are single stage,oil-lubricated rotary vane vacuum pumps with oil re-circulation system.The lubricant system is rated for continuous operation of high intake pressures so that the pump may be used in a versatile manner in most rough vacuum applications. The pumps are used for suction of air also in presence of water vapour and for continuous industrial use. TMS Series pumps are made from high quality materials, has economical features which matches together to achieve high pumping speed over the range of absolute pressure 1,000 mbar-0.5 mbar; high water vapour tolerance and low noise level; no pollution; air cooled: built-in anti-suck-back system. The pumping capacities available are17 m 3/hr, 35 m 3/hr, 65 m 3/ hr, 100 m 3/hr and 150 m 3/hr.

For more information, please contact: Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Garden Road Chennai 600 010 Tel: 044-26448983, 26448558 Fax: 91-044-26441820 E-mail: sales@toshniwal.net

Optimum Characterisation System The optimum characterisation system for your nano-particle, colloid or protein applications, the Zetasizer Series measures particle and molecular size from below a nanometer to several microns, zeta potential, electrophoretic mobility and molecular weight. In addition, the system can be connected to a GPC/SEC system to enable it to be used as a chromatography detector. The system is available in a range of variants that allows you to select the best system for your application and budget. Zetasizer Neo Series - comprises of various models for particle and molecule size, zeta potential, molecular weight. Zetasizer APS – automated particle size by dynamic light scattering from 96 and 384 well plates. Zetasizer uV – batch DLS and SEC-LS, dual integrated light scattering capability for proteins. Zetasizer Nano ZSP - premium performance system for particle size, zeta potential, molecular weight, protein mobility and microrheology. For more information, please contact: Aimil Ltd Naimex House A-8 Mohan Co-op Indl Estate Mathura Road New Delhi 110 044 Tel: 011-30810200 Fax: 91-011-26950011 E-mail: info@aimil.com

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Intrinsically Safe Portable Analyser Designed for the measurement of toxic and flammable gas samples, the intrinsically safe Micro i.s is a unique analyser certified to Zone 0 and Zone 1 and suitable for measuring per cent levels of O 2 , CO and CO 2 . Features intrinsically safe design to ATEX and IEC Standards ensures safety operation in hazardous environments. It is available in non-pumped or pumped version with optional sample conditioning kit.

For more information, please contact: Spectris Technologies Pvt Ltd Plot No: A-168 MIDC Thane-Belapur Road Khairane Navi Mumbai 400 710 Tel: 022-39342700 E-mail: MEI_Sales@servomex.com

Pin Hole Detector Pin hole detector PHD-05 is infrared light-based inspection system designed for detection of microtears/pin hole in formed aluminium foil laminate. The system is used in the pharma industries for detection of micro-tears/pin hole after cup formation of the aluminium foil in ALU-ALU blister pack machine

For more information, please contact:

Technofour Electronics Pvt Ltd Gat No: 3 (PT), 5 (PT), 243 (PT), Kasurdi (Kheba) Khed Shivapur-Saswad Road Post: Khed Shivapur, Tal: Bhor Dist: Pune, Maharashtra 412 205 Tel: 02113-305200, 305246 Fax: 91-02113-305250 E-mail: pcssales@tepl.co.in / teplinbox@gmail.com

Environmental Analysis Chromate is useful in many industries â&#x20AC;&#x201C; in the production of pigments and dyes for textiles, paints and colored glass, anodized or plated on to metals for surface finishing applications, as an oxidizing agent to tan and process leather, and as a corrosion inhibitor in industrial cooling towers. Chromate easily leaches from soil to ground and surface waters and can enter the air through evaporation and combustion processes. Monitoring waste streams containing chromate is extremely important because chromate is highly toxic even in minute concentrations; a property which is enhanced by the high solubility of chromate and its affinity for leaching. In the method concerned, the target analyte is mixed with reagents in a fully automated procedure, resulting in a soluble product which can be measured photometrically at a wavelength of 560 nm. For more information, please contact: Metrohm India Ltd 205/206, Sector III Bldg 5 Millenium Business Park Mahape, Navi Mumbai 400 710 Tel: 022-27781003, 27781026, 27781027 Fax: 91-022-27781028 E-mail: joy@metrohm.in

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Twinlobe Blowers/Vacuum Booster Twinlobe blowers/ vacuum booster is of modular design for max flexibility, always allows meeting customer’s requirements, and has positive displacement, high operating speed due to dynamically balanced rotors. It is entirely mechanical and light in weight with relatively low power consumption. It finds application in cement, effluent treatment, pollution control plant, fertiliser, textile, glass/tube industries, pharma and chemical. For more information, please contact:

Octagonal Blender Octagonal blender available in standard cGMP and customised models with SS-304/315/316L contact parts.It is most suitable for dry mixing of materials in granular form. Gives best result for granules due to slow RPM and the octagonal shape. It is provided with limit switch for operator ’s safety.Bigger batch size at low power consumption.It has a modern PLC with manual operating system Available in batch capacities ranging from 50 to 3,000 kg as per client’s requirements, depend on bulk density. For more information, please contact:

Indovac Pumps & Engg Co 21 Anand Raj Indl Estate Sonapur Lane, B/h Asian Paints Off LBS Marg, Bhandup (W) Mumbai 400 078 Tel: 022-25664917 Telefax: 91-022-25664917 E-mail: indovac@yahoo.co.in

IPEC Engg Pvt Ltd Plot No: 5175 GIDC, Ankleshwar Gujarat 393 002 Tel: 02646-221175 Telefax: 91-022646-225175 E-mail: md@ipecengg.com / marketing@ipecengg.com

Ribbon Blender Ribbon Blender is available in Standard cGMP and customised models with SS-304/316/316L contact parts. The container shape and the mixing stirrer give continuous movement resulting in better quality mixing and blending. Ribbons are designed in such a way so as to provide both radial and linear motion for a complete homogenous mixing. Various types of ribbon blenders such as pressure, double spiral, etc, are available. It has a modern PLC with manual operating system.Available in batch capacities ranging from 50 to 5,000 kg, as per client’s requirements, depend on bulk density.

For more information, please contact:

IPEC Engg Pvt Ltd Plot No: 5175, GIDC, Ankleshwar Gujarat 393 002 Tel: 02646-221175 Telefax: 91-02646-225175 E-mail: md@ipecengg.com / marketing@ipecengg.com

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Moisture Analysis Even small amounts of humidity can change the attributes of sensitive materials. For substances such as foodstuffs, chemicals and plastics, moisture is a critical quality determinant. Making accuracy in this important test even more critical, moisture content levels are often set by regulatory standards to ensure consumers get what they pay for. Fortunately, as described in a new, free white paper from Mettler Toledo, ensuring a halogen moisture analyzer is generating accurate results has never been easier. A fast routine test ensures trusted moisture results explains the benefits of routine testing using SmartCal, a highly accurate yet easy-to-handle test substance. In just ten minutes, SmartCal monitors a moisture analyzer ’s performance and assesses the proper functioning of both the heating element and internal balance mechanism. Periodic assurance can help prevent tedious rework, loss of expensive production batches, and even fees or fines. For more information, please contact: Mettler-Toledo India Pvt Ltd Amar Hill, Saki Vihar Road Powai, Mumbai 400 072 Tel: 022-42910111 Extn: 256/115

Shipping Solution for Temperature-sensitive Payloads ACH Foam Technologies’ DuraTherm PLUS+ is an advanced cold chain shipping solution that assures payload temperatures remain between 2 o to 8 oC for a 24-hour delivery window. Validated to International Safe Transit Association (ISTA) 7D Standards, DuraTherm PLUS+ is available in summer and winter profiles to accommodate off-the-shelf seasonal packout solutions for pharma and other products with acute temperature sensitivity. ISTA’s rigorous testing assures that product temperatures can be controlled within a very narrow range for up to 24-hours. DuraTherm PLUS+ is also pre-qualified to ISTA 7E for summer and winter profiles. A key facet of DuraTherm PLUS+’s ability to maintain near-constant temperatures is the expanded polystyrene (EPS) foam cooler core, which boasts superior insulation properties. ACH Foam Technologies’ laboratory developed packaging kit includes the DuraTherm PLUS+ cooler, inner payload packaging, gel pack refrigerants, outer corrugated shipping box, and precise packout instructions. ACH Foam Technologies manufactures cold chain and protective packaging to architectural insulation and industrial applications.

For more information, please contact: ACH Foam Technologies 8700 Turnpike Drive, Suite 400 Westminster, CO 80031, U.S.A. Tel: 855-597-4427 Fax: (303) 428-2595 E-mail: mburk@achfoam.com

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Pharma Bio World

Extruded Profiles (Silicone/Viton/EPDM) APPL offers a wide range of silicone extruded gaskets in more than 1,000 different shapes and designs (in round and square types). APPL’s extruded gaskets (Autoclave) are made from Food-Pharma Grade pure silicone rubber which can easily withstand a temperature range of -80 to +250°C.Extruded gaskets are available in square crosssections like 6 x 6 mm, 8 x 8 mm, 10 x 10 mm, 20 x 20 mm, 25 x 25 mm, etc, with or without hollow. These extruded gaskets are available in red, white, orange or any colour as per customer ’s requirement. These extruded gaskets are manufactured from fully automatic microwave continuous curing system which ensures accurate dimensional properties, glossy surface finishes and aesthetically beautiful colours. Extruded gaskets can be used in clean room doors, telecom shelters, air tight door seal application, bakery ovens, freeze doors, pharma processing machine’s doors, autoclaves, isolators, dry heat sterilizers, etc. For more information, please contact:

Ami Polymer Pvt Ltd 319 Mahesh Industrial Estate Opp: Silver Park, Mira-Bhayander Rd, Mira Road (E) Thane, Maharashtra 401 104 Tel.: 022-28555107, 28555631, 28555 914 Email: mktg@amipolymer.com

Vacuum Dryer Toshniwal offers rotary double cone dryer designed for drying and mixing of powdery and granular materials used in pharma, food and chemical industries, especially suitable for the special requirements such as thermal sensitive raw materials; easily oxidized hazardous materials; materials with requirements in crystal shape; materials whose solvent should be recovered; materials requiring low-content of residue volatile matter; etc. The dryer consists of a conical cylinder provided with a jacket for hot water, steam or oil heating, the indirect heating process is carried out under vacuum, and recovery of solvent is possible by conducting the vapour generated during drying operation. When the dryer rotates rapidly and thorough intermixing of the entire batch brings every particle in contact timely and repeats again and again. With the heated surface for more rapid heat conduction permits high speed drying without raising the drying temperature to the danger-point of the material being processed. The heat efficiency of the drying system is two times greater than the ordinary dryer.

For more information, please contact: Toshniwal 267 Kilpauk Garden Road Chennai 600 010 Tel: 044-26445626, 26448983 E-mail: sales@toshniwal.net

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December 2017  53

Portable Benchtop Analyser for Measuring O2 and CO2 The only truly portable battery powered gas analyser with MCERTS Certification, the MiniMP is a portable analyser designed to offer single or dual measurement of O 2 and CO 2 by utilising servomex’s advanced paramagnetic and infra-red sensing technologies. Features EN15267-3 (MCERTS V3.3, Annex F) makes the MiniMP for source testers that require reference O 2 analyses for CEMS verification. Non-depleting sensor design ensures long service with minimal calibration.

For more information, please contact: Spectris Technologies Pvt Ltd Plot No: A-168 MIDC Thane-Belapur Road Khairane Navi Mumbai 400 710 Tel: 022-39342700 E-mail: MEI_Sales@servomex.com

Process Analyzer The 202X Process Analyzer family comes in three basic configurations, covering several market needs. The 2026 Titrolyzer is suitable for titrimetric, ion selective or pH measurements. The 2029 Process Photometer performs photometric absorption measurements in the visible light range. A 7” full-colour touchscreen shows trend graphs and allows easy access to your data. These process analyzers are especially suitable for analysis in the chemical, petrochemical, semiconductor, food and beverage, potable water, and environmental branches. Metrohm Process Analytics can offer process analyzers which are configured for each specific application challenge. Sample dilution, extra reagents, or even another sample stream can be added with the addition of peristaltic pumps in the modular wet part. Strict separation of wet part and electronics ensures safe operation in harsh environments. The electronics part is housed within non-corrosive polyester-coated stainless steel. With an Ingress Protection rating 66, the analyzer is guaranteed to be dust and water-tight. Metrohm Process Analytics provides virtually any sample preconditioning system, such as cooling or heating, pressure reduction, degassing, filtration and more.Information including results, remote control and status info, can be communicated through discrete I/O (ie, analog outputs digital in/outputs), MODbus TCP/IP (Ethernet), or RTU (RS485) communication. Remote control is possible through VNC (Ethernet). Results can also export to USB. For more information, please contact:

Metrohm India Ltd 205/206, Sector III Bldg 5 Millenium Business Park Mahape, Navi Mumbai 400 710 Tel: 022-27781003, 27781026, 27781027 Fax: 91-022-27781028 E-mail: joy@metrohm.in

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Pharma Bio World

Nanoparticle Tracking Analysis Visualise and measure nanoparticle size and concentration. The Malvern NanoSight range of instruments utilises nanoparticle tracking analysis (NTA) to characterise nanoparticles from 10-2,000 nm in solution. Each particle is individually but simultaneously analysed by direct observation and measurement of diffusion events. This particle by particle methodology produces high resolution results for particle size distribution and concentration, while visual validation provides users with additional confidence in their data. Both particle size and concentration are measured, while a fluorescence mode provides differentiation of labelled or naturally fluorescing particles. For more information, please contact: Aimil Ltd Naimex House A-8 Mohan Co-op Indl Estate Mathura Road, New Delhi 110 044 Tel: 011-30810200 Fax: 91-011-26950011 E-mail: info@aimil.com

Double Rotary Tableting Machine A double-sided tablet press with GMP features. Conceived by world class designers and crafted with high quality precision engineering to deliver you a better value through innovation. It is a high-speed fully automated operation for high volume products. Provided single point collection are made. Two separate discharges also can be provided.

For more information, please contact: Pharma Chem Machineries 311/2484 Motilal Nagar No: 2, M G Road Goregaon (W) Mumbai 400 090 Telefax: 91-022-28735321 E-mail: pharmach@gmail.com pharmachem79@gmail.com

Oval Gear Meter The measurement element of this positive displacement oval gear meters consists of two precision oval gears. The revolution can be sensed by a magnetic-field-controlled pulse generator, resulting in only two moving parts, ie, ovalwheels. These oval gear meters can be used for application of nearly all operating condition. Features very high/very low temperatures; low and extreme high viscosities; nominal diameter DN 4 to DN 400; direct measurement of volume respective of volumetric flowrate; measurement at high viscosities and high accuracy; and 2-wire technique.

For more information, please contact: Toshniwal Hyvac Pvt Ltd 267 Kilpauk garden Road Chennai 600 010 Tel: 044-26445626, 26448983 E-mail: sales@toshnwial.net

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events diary    Date: 15 th - 17 th February, 2018 Venue: Bangalore International Exhibition Centre, Bengaluru India Pharma 2018 is a major event to increase overall growth of Pharma sector including exports and focus on increase of Domestic production in the sector by Government of India & FICCI, with the active participation from all Stakeholders. this event provides a platform to global investment community to connect with stakeholders in Pharma sector in India, Central and State Governments, leading business leaders and top executives from the industry, academics and experts from the world. India Pharma 2018 covers the whole process of Pharmaceutical Manufacturing, from various kind of manufacturing/processing machineries to Lab Equipment, Analytical Instruments, APIs and other total solutions.  Ravi Verma Assistant Director Ph: +91 9873522631 Email: ravi.verma@ficci.com

        Date : 17 th February 2018 Venue: The Oberoi Dubai, The Oberoi Centre, Al A'amal Street, Dubai International Conference on Drug Discovery & Development (ICDDD-18) is a globally recognized, highly appreciated platform globally with the richness of abundance. To be held on 17 th February, 2018 at Dubai, this event is sure to repeat its history again. Encapsulating with it the different domains of people, researchers, thought leaders, speakers and unique visitors, International Conference on Drug Discovery & Development (ICDDD-18) brings out the best of the best to the world.       

56  December 2017

           Date: 26 th – 27 th February 2018 Venue: London, UK Following the tradition of successful Congresses held in several European countries, Dubai, Spain, Italy, India, South Africa and USA, the Organizing Committee of ConferenceSeries Ltd is pleased to invite all the participants across the globe to attend the 12 th world Congress on Pharmaceutical Sciences and Innovations in Pharma Industry. The conference is a specially organized two day event which will provide a multi-channel communication platform that brings together both “producers” and “consumers” of pharma world of generic sector. It includes prompt keynote presentations, Oral talks, Poster presentations and Exhibitions. It is a perfect platform for researchers, scientists and, delegates to share experience, foster collaborations across industry and academia, and evaluate emerging technologies across the globe.  Ph: 7025085200 Email: pharmaindustry@pharmaceuticalconferences.org

  Date: 19th – 21st March 2018 Venue: Berlin, Germany After a successful conference of Pharmaceutica 2017, ConferenceSeries Ltd is currently bringing forth “16 th International Conference and Exhibition on Pharmaceutics & Novel Drug Delivery Systems” (Pharmaceutica 2018) at Berlin, Germany. This event covers various aspects of Pre-Formulation & Formulation Aspects, Pharmacokinetics and Pharmacodynamics in Drugs, Drug Targeting and Design, Routes of Drug Delivery, Nanoparticulate Drug Delivery Systems, Nanotechnology in Drug Delivery, Pharmaceutical Nanotechnology, Smart Drug Delivery Systems, Biomaterials in Drug Delivery, Vaccine Drug Delivery Systems, Medical Devices for Drug Delivery, Peptides and Protein Drug Delivery, Global Drug Delivery Policy, Entrepreneurs Investment Meet.  Dileep G Ph: +44 8000148923 Email : pharmaceutica@pharmaceuticalconferences.org

Pharma Bio World

bookshelf Pharmaceutical Microscopy (Hardcover) Author: Robert Allen Carlton Price: USD 83.09 No of Pages: 321 pages Microscopy plays an integral role in the research and development of new medicines. Pharmaceutical Microscopy describes a wide variety of techniques together with numerous practical applications of importance in drug development. The first section presents general methods and applications with an emphasis on the physical science aspects. Techniques covered include optical crystallography, thermal microscopy, scanning electron microscopy, energy dispersive x-ray spectrometry, microspectroscopy (infrared and Raman), and particle size and shape by image analysis. The second section presents applications of these techniques to specific topics of pharmaceutical interest, including studies of polymorphism, particle size and shape analysis, and contaminant identification. Pharmaceutical Microscopy is designed for those scientists who must use these techniques to solve pharmaceutical problems but do not need to become expert microscopists. Consequently, each section has exercises designed to teach the reader how to use and apply the techniques in the book. Although the focus is on pharmaceutical development, workers in other fields such as food science and organic chemistry will also benefit from the discussion of techniques and the exercises.

Technology Transfer: An International Good Practice Guide for Pharmaceutical and Allied Industries (Hardcover) Author: Mark Gibson (Editor) Price: No of Pages: 245 pages This book serves as a comprehensive overview and guide to the technology transfer process for pharmaceutical drug substance and products and the corresponding analytical methods and tests from R&D to production. Each of the contributors has extensive personal knowledge and experience in this field and each has provided practical examples to explain the critical factors involved in achieving successful and effective technology transfers. This book will benefit practitioners working in the pharmaceutical science and related industries from R&D, commercial production to project management, clinical, regulatory affairs and quality assurance.

Metal Nanoparticles in Pharma (Hardcover) Authors: Mahendra Rai PhD, Ranjita Shegokar PhD (Editors) Price: USD 157.74 No of Pages: 493 pages Completely dedicated to the biomedical applications of metal nanoparticles, this book covers the different toxicity problems found in healthcare situations and also provides comprehensive info on the use of metal nanoparticles in treating various diseases. Metal Nanoparticles in Pharma is the first edited volume to set up the discussion for a clinical setting and to target a pharmaceutical audience of academic and industry-based researchers. Pharma Bio World

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