Pharma Bio World February 2018 by Pharma Bio World

www.pharmabioworld.com PHARMA BIO WORLD VOL 16 ISSUE 05 FEBRUARY 2018 MUMBAI

Biosimilars Biopharmaceuticals

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FEATURES 08

Some Thoughts on How to Secure Sustainable Future in Biosimilars World - Dr Satinder Singh, Sanjeev Gupta, Dr Ashok Kumar

Tailored Treatments for Patients with Precision Medicine - Praveen Gupta

Transfer of Technology - An Indian Perspective - Saurabh Anand

08 28

Career in Pharmaceutical Management More Promising than Ever Before - Dr Ashok Peepliwal

Continuing Innovation with Single-Use Technologies - Amit Chopra NEWS FEATURE

Union Budget 2018: Reactions from the Indian Pharmaceutical Industry NEWS UPDATE

Press Release CORPORATE AFFAIRS

Products

Events

BACKYARD 57

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Ad Index

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6 â&#x2014;&#x201E; February 2018

Pharma Bio World

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Some Thoughts on How to Secure Sustainable Future in Biosimilars World Biosimilar medicines provide a major opportunity for cost savings throughout globe. However, in order to deliver these beneﬁts it is imperative that the biosimilar medicines market remains sustainable.

iologics, the complex recombinant therapeutic proteins produced from living organisms, have created immense value to patients due to their usefulness in prevention, treatment and diagnosing a variety of diseases such as cancer, chronic kidney diseases and autoimmune disorders; otherwise nonmanageable by existing therapies. It is therefore this attribute of providing unmet medical need, which facilitated biologics to create a niche for themselves in pharma industry. ‘Biosimilars’, also known as ‘follow-on biologics’ can be vaguely considered as generic versions of the innovator products, but in reality are significantly different, than the parent molecules due to their variable composition.

Dr. Satinder Singh Manager- R&D (IPRM) Ipca Labs Limited, Mumbai

Sanjeev Gupta, Ph.D., General Manager- Advanced Biotech Lab (Biosimilar R&D) Ipca Labs Limited,Mumbai

Dr. Ashok Kumar FRSC President – Centre for Research & Development Ipca Labs Limited, Mumbai 8 ◄ February 2018

Biologics versus Small Molecules Unlike small molecules which are clearly characterizable products with well defined structures and can be produced in identical form in bulk; biologics are a mixture of related molecules with molecular weight as high as 150,000 Da, decorated by a variety of groups due to post translation modification eg. oligosaccharides, sialic acid moieties, phosphorylations etc. The post translational modifications are specific to host cell and growth conditions. It is important to note that these modifications and specific folding are very critical to the biological activity of these drugs. For example, a simple misfolding or even an aggregation can trigger immunogenicity in patients and thus can have devastating health hazards. Apart from the differences in the complex molecular structure of biologics/ biosimilars versus simple small molecular drugs of molecular weight ~180 Da, the

development as well as manufacturing of biologics requires highly cost intensive sophisticated infrastructure. The companies with deep pockets can well afford to have the same, but it is noteworthy that it also requires different knowledge and skill sets to handle proteins, pretty different than small molecular drugs, understanding of the living systems and the biochemistry of the host, key to sustain its life as well as expressing the desired protein. Furthermore, compared to generic small molecules, the biological products have less shelf life and often require refrigerated conditions to maintain biological activity and prevent breakdown or aggregation. This perishable nature of biologics significantly minimizes the time frame to generate revenue out of the product, whilst inflating the shipping and storage cost. Challenges and Remedies in Biosimilars Development Even if the biomanufacturing process of biosimilars are followed in strict accordance with the conditions prescribed by innovator and exercising QBD, it is practically impossible to develop a replica of the parent molecule and therefore follow-on biologics are classified as ‘similar’ and not ‘same’, to the innovator product. The development and validation of multi-tier manufacturing process, therefore, requires rugged analytical and biological testing for initial and final characterization as well as efficacy and toxicity evaluation of the biosimilars. Even a slight modification in any step during manufacturing can lead to variations in glycosylation pattern, addition of other Pharma Bio World

Figure 1: Complete Manufacturing Process side chains to form a secondary structure, folding to form a tertiary structure and complex interactions to form a quaternary structure and can affect safety and effectiveness of intended biosimilar. If the process is not tightly regulated during development and scale-up to commercial, significant changes in quality attributes and overall characteristics of biosimilars are inevitable. Therefore, the multisite production of a biosimilar with the established validated process may still result in variable quality attributes and different overall characteristics of finished product. Hence, a well crafted stringent control strategy at each stage of the process is must to ensure minimal batch to batch variation of a biosimilar.

to regulatory authorities. All the analytical methods employed to characterize the product, the functional assays carried out to assess potency and preclinica studies conducted to verify toxicity and safety should exactly resemble the one conducted by innovator to establish closest similarity to the reference product. The structural and post translational modifications should be assessed thoroughly before submitting the dossier to regulatory authorities. Even though a biosimilar is cleared by regulators, surmounting the market barrier owing to the general skepticism in patients / prescribers, considering biosimilars as substandard version of their branded product, remains a daunting task.

The quality, potency, safety and efficacy of a biosimilar are of paramount importance

An imperfectly similar biologic may need to be well supported by pre-clinical toxicity,

10 ◄ February 2018

clinical efficacy and stability studies for the approval of marketing authorization from regulators, but the qualification of an improvised version of the innovator molecule justified and fortified with persuasive potency, efficacy, safety and quality data as ‘biobetter’ may even be more difficult and costly to sail through regulator barriers because developing a ‘biobetter’ warrants a new approval process. Approval of the product out of purview of biosimilars, will be considered as a new molecule and will have to go through 505(b)(1) in the USA or with the steps specified in Schedule Y, if taken up for qualification In India. It is because of these facts; obtaining “interchangeability” status for a biosimilar with an innovator’s product is not easy & is currently being offered by USFDA on case by case basis. Considering the development of Pharma Bio World

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Figure 2: Cell Line/Clone Development biosimilars to be as simple as developing ANDAs and experience of generic small molecular drugs good enough to be successful in biosimilars business as well, many generic pharma companies have ridden on the biosimilar development wave to tap the global biosimilars market, which is anticipated to reach USD 25.83 billion by 2025; without thoroughly analyzing that it’s a different ball game altogether, entailing huge investments, and longer timelines with no guarantee of return on investment in short to mid-term. Interestingly, allured by high sales figures, several companies across the globe whether big MNCs, midsize or small SMEs have joined the band wagon to focus and develop the same top 10-15 molecules without envisaging the 12 ◄ February 2018

kind of market competition they may have to face by the time their molecule reach the market. It is pertinent to mention that the development of a biosimilar takes more than 7 years under even most favorable conditions. As evident from market information, many generic companies have either suffered heavy losses in this venture or have shut down their development program in recent past and may come true for many more players in future, if they do not learn from other’s mistake. A Model for Long Term Sustainability in Biosimilar World A lean structure with optimum investment powered by highly qualified and skilled

personnel is the key to sustainability, but to keep the company ahead of the herd by at least 7-10 years is important to avoid unwarranted competition and is not difficult to achieve if it inculcates and allows the culture of innovation to prevail. Contrary to general belief, innovations are not the hallmark of R&D and can be implemented at any stage starting from the selection of the molecule(s) for development till strategic partnering, tactical marketing, logistics etc. based on the company’s inherent strength and expertise. It is important to note that being first mover may be of some advantage to a company but does not guarantee long term sustainable growth in a generic market. Pharma Bio World

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Figure 3: Use of HTP devices to achieve high titer and good quality Based on the personal experience, authors believe that R&D should invest at least 15% of its total time in keeping abreast with the latest developments and exploring and implementing new ideas to improve or fine tune processes at every stage starting from molecular/ cell biology to upstream/downstream or formulation development before freezing the process to provide stable yet quality clones, high titers, quality and yields of the desired product giving an edge against the competitors. Development of in-house clones is most preferred to have better understanding and control of the manufacturing process. ZSelection of apt platform for development of biosimilars shall help match critical quality attributes, such as glycoprofile pattern, aggregation, clips or truncation to that of innovator product. Single-use 16 â&#x2014;&#x201E; February 2018

upstream and downstream technologies have created distinct market niches and continue to evolve. Manufacturing process should be constantly refined employing latest state of art bio-processing methods and systems to increase the efficiency, overall productivity whilst maintaining biosimilar quality, safety and potency. In summary, the endeavour to foray into biosimilar development should be a well articulated and calculated move with long term vision, good risk appetite and sound understanding and planning. Even if company has deep pockets, collaboration with like minded MNCs to share the potential risk associated with development of biosimilars may be a wise move in long run. The same has been manifested well by Biocon-Mylan partnership in securing USFDA approval for biosimilar version of Trastuzumab.

The entry of more biosimilars in the market may increase price pressure and toughen the competition further; thus compelling the manufacturers to offer greater discounts. Though EU market is most mature and has evolved a lot since 2001, when compared to relatively nascent US market with respect to scope of the guidelines, the choice of the reference product, the data required for product approval, case-by-case approach and post-marketing adverseevent vigilance system; it is relatively small in size to offer bankable returns in contrast to US because of limited adoption of biosimilars in countries like Spain, and various other factors beyond the scope of the review.

Contact: ashok.kumar@ipca.com Pharma Bio World

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TailoredTreatments for Patients with Precision Medicine In an era where medicine is recognizing that a one-sizefits-all approach is not always appropriate, it is necessary to treat patient populations using a tailored approach.

edicine as a field is undergoing a revolution. One of the areas that is driving this revolution is the area of precision medicine. Precision medicine is an approach to patient care that allows medical professionals to select tailor made treatments that are most likely to help patients based on their unique genetic understanding of their disease. This area of treatment development is also called personalised medicine. The idea of precision medicine is not new, but recent advances in science and technology have helped speed up the pace of this area of research. A traditional approach to medicine is based on iterative one size fits all protocols. That means all cancer patients at the same stage and type of cancer receive the same treatment. However, different people may respond differently. After decades of research, scientists and doctors now understand that patients’ tumours have genetic mutations that cause the spread and growth of tumours that are unique to individual patients. Also the same cancer-causing changes may be found in different types of cancer due to the same set of genetic mutations.

Praveen Gupta Managing Director Premas Life Sciences 18 ◄ February 2018

Hence most medical treatments which exist are intended for the average patient. While talking about Precision medicine it matches individual patients with the treatment that will work best suit them hence it is called personalized medicine or individualized medicine. So, precision medicine takes individual difference into account. Variations like our genes, environment, lifestyle, and even in the microscopic organisms that are living inside of us.

With precision medicine technologies including but not limited to gene sequencing, companion diagnostics, pharmacogenomics, bioinformatics, and big data analytics are expected to drive a treatment protocol that is tailor made to each patient’s specific genetic mutations. Genes and Environment Decide Our Health Status The core of precision medicine is its efforts to understand how variations in our genes impact our health. Just as genetic variations influence our physical characteristics like height and hair color, they also contribute to our likelihood of getting specific diseases. While some genetic variations protect us from disease, and some make us more susceptible. Genetic variations also impact how we counter to medications and other interventions. For example, it is crucial to know a person’s blood type before giving them a transfusion. And by knowing individual variations in the enzymes that process drugs can help a doctor prescribe the right dose of the right medication. Factors from the environment—including our physical surroundings, our diet, and our lifestyle—also influence our health. For instance, even if somebody inherits genetic variations that make them vulnerable to skin cancer, they can reduce their chances of getting cancer by protecting themselves from the sun. Precision medicine involves understanding how factors from the environment interact with genetic variations to influence health. When pooled with information about a person’s environment, genetic information becomes even more dominant. Pharma Bio World

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Genetic Testing Scenario in India Cancer is a lethal disease that is swallowing India silently. Even those types of cancer which were once known to be rare are no longer rare. With this fatal disease on a rise, it is taking lives of many with each passing day. As per the reports “In India, approximately 4.5 lakhs people are living with the disease, and there are more than 7 lakhs new cases being registered yearly and 5,56,400 deaths which are known to be cancer-related. Also it is estimated 71 percent of all cancer-related deaths are happening in the age group between 30 to 69 years.” In women cancer cases as well as mortality is uphill. The main reason can be attributed to low awareness and late detection. As per the data “Our country stands third after China and USA for the highest number of cancer cases among women which are growing per annum at 4.5-5%.” Among men lung, oral and stomach cancers are the leading causes of death due to this noxious disease. About one hundred different types of cancer are known in humans, and all are different from one another such as the average age at which they appear, the growth rate and the tendency to metastasize. From newborn babies to aged people, everyone is at risk of cancer. Currently cancer treatments include a combination of surgery, chemotherapy, radiation therapy, and immunotherapy. Which treatment protocol is employed has till now depended on the type of cancer, its size, and whether it has spread. With precision medicine, information about genetic changes in your tumour can help decide which treatment will have 20 ◄ February 2018

the greatest efficacy. There are drugs that have been proven effective against cancers with specific genetic changes and are approved by the US FDA or are under development. Increasingly more of these drugs are becoming available to Indian patients and hence the need for companion diagnostics with the drug becomes more and more important. In India we already have a cohort of genetic tests undergoing research trials which will help decide which treatments a patient’s tumour is most likely to respond to, sparing the patient from receiving treatments that are not likely to help. Nodal cancer centres including Tata Memorial Hospital (TMH-ACTREC), Malabar Cancer Centre (MCC), AIIMS, PGI, TMC, CNCI along with private labs such as Strand-HCG, Med genome, GenepathDx, KDAH and many more are steering research studies on how to test whether treating patients with treatments that target the cancer-causing genetic changes in their tumours, no matter where the cancer develops in the body, will help them. These treatment protocols include a set of drugs that are known as targeted therapies.

HIV AIDS and Hepatitis C Patients Too will Benefit Tremendously from Precision Medicines Another area of active application in India is with regards to drug resistance for cases of HIV AIDS and Hepatitis C. Over 10% of patients develop drug resistance to the initial line of therapy for these disorders and then have to move through other lines of treatments based on an iterative process. We now have active projects in India where genomics is being used to stratify drug resistant patients to customise the treatment protocol for them.

Ultimately precision medicine is driven by patient data that look at effect of these targeted therapies via clinical trials. With our current cohort of projects in the space combined with the launch of these targeted therapies in India, uptake of precision medicine in India. Just as President Obama’s State of the Union address launched a national precision medicine initiative in the USA in 2015, India too needs a national level initiative. Such a national level initiative that ties in all projects plus adds more can help us redefine the treatment protocol not just for Cancer but all other complex disorders that India faces. Future of Precision Medicine Researchers have not yet discovered all the genetic changes that can cause cancer to develop, grow, and spread. But, slowly and gradually they are making progress and discovering new changes every day. Information from researches is being gathered in databases where researchers from across the country can access the data and utilize them in their own studies. This access and sharing of data helps move the field of precision medicine forward. Once genetic changes are discovered, then this followed by another active area of research which entails looking for drugs that can target these changes. After that there is testing of these drugs with people in clinical trials.

Contact: jimmybluepigeon@gmail.com Pharma Bio World

Transfer of Technology - An Indian Perspective Technology transfer is the process of transferring scientific findings, knowledge,manufacturingprocess, technologies, processes etc. from one organization to another for the purpose of further development and commercialization. This article discusses the Indian scenario concerning transfer of technology.

Saurabh Anand Senior Associate K&S Partners 22 ◄ February 2018

ne of the most acceptable and unambiguous definitions of “Technology Transfer” or in other words “Transfer of Technology” is the process by which “commercial technology” is disseminated from one industry to another, and/or among different economies. In common parlance, the said terms are often misconstrued to be limited only to the transfer of a patent with respect to a particular product, which is patented. Meaning thereby, the product of the technology is often fused with the technology itself. However, in actual commercial terms, technology is often considered to be a blueprint, which once obtained would promise better commercial output and it largely depends upon the industry. For instance, in mechanical industries, transfer of technology might include transfer of an end product, involving multiple IP rights. However, for pharmaceutical industries, transfer of technology might include transfer of know-how of a process to obtain a product, which will not always be a fullfledged transfer of IP rights, as certain IP rights will be developed upon development of that particular product. Thus, getting a patent is not always a pre-requisite for initiating or rather indulging in a “Technology Transfer” arrangement. This dynamic model often creates multiple hurdles for a transferor to enter into such transactions, due to the vulnerability of the “technology” at the whims and fancies of the transferee. This is often observed in cases of transborder transactions, wherein the transferor who wishes to expand its footprint in a particular country, is hesitant to enter into such kind of arrangements due to the lack of confidence in the laws governing the importing country. However, at the same time such transfer of technology is often required to give a technological as well as economical boost to the importing country in an era wherein technology is changing

overnight and the thrust of adopting to changing technologies is also increasing at the same pace. At this juncture, the laws of the importing country play a vital role in preparing a ground to facilitate such transactions. Undoubtedly, strong IP laws play a crucial role for any transferor to prefer a particular jurisdiction over another, but simultaneously enforcement of such laws in order to protect the IP becomes the game changer. For instance, mere mention of provisions for remedies in cases of infringement would no doubt portray a positive image of the importing country and at the same time if such statutory provisions have actually been implemented by way of granting injunction or directing to pay for damages and so on, it definitely acts as a springboard for the transferor to actually start investing in such importing countries. Section 83 of the Indian Patents Act, 1970 which is in consonance with Article 7 of the TRIPS Agreement recognises this concept as under: General principles applicable to working of patented inventions. – Without prejudice to the other provisions contained in this Act, in exercising the powers conferred by this Chapter, regard shall be had to the following general considerations, namely:• that patents are granted to encourage inventions and to secure that the inventions are worked in India on a commercial scale and to the fullest extent that is reasonably practicable without undue delay; • that they are not granted merely to enable patentees to enjoy a monopoly for the importation of the patented article; • that the protection and enforcement of patent rights contribute to the promotion of technological innovation Pharma Bio World

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and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations; Thus, the Indian Patents Act, recognises the twin-benefit of Technology Transfer, that is, encouragement of innovation as well as protection and enforcement of patent rights. In addition to IP laws, the strength of ancillary laws like contractual laws, regulatory laws and so on, play a critical role in aiding such transactions. Further, various Government initiatives like FDI, tax exemptions, fast approvals, digitalization and the like are other factors which provides the impetus for Transfer to Technology. For instance, the pharmaceutical sector is one of the key 25 sectors identified by the Government of India under the ambitious ‘Make in India’ initiative, which is likely to provide the necessary momentum to the sector in order to achieve its true potential. Following this, is the nod by the Union Cabinet for FDI up to 100 percent under the automatic route sector for manufacturing of medical devices subject to certain conditions. Further, the implementation of the Goods and Services Tax (GST) is expected to be a gamechanger for the Indian Pharmaceuticals industry as it will lead to tax-neutral interstate transactions. Till date, the Government of India has undoubtedly taken multiples initiatives towards improvements in the pharmaceutical sector however, they are mainly restricted to just that and do not focus on the concept of technology transfer to reduce the amount of input in such an industry. For instance, in the Union Budget 2017-18, the Department of Biotechnology (DBT) received Rs. 2,222.11 crore, an increase of 22 per cent, to continue implementing the Department’s National Biotech Strategy. Later on, in an attempt to revive the active pharmaceutical ingredient (API) and the bulk drug market in India, the Government of India has proposed peak 24 ◄ February 2018

customs duty on the importing of APIs and also plans to establish mega drug parks to promote domestic production. It has also unveiled ‘Pharma Vision 2020’ aimed at making India a global leader in end-to-end drug manufacture. Approval time for new facilities has been reduced simultaneously to boost investments. The Government has also introduced systems such as the Drug Price Control Order and the National Pharmaceutical Pricing Authority in order to deal with the issue of affordability and availability of medicines. Against this backdrop, it is imperative to note that the concept of technology transfer can greatly help in reducing the cost of R&D in this sector if the government also provides incentives for the same especially since there has been a six-fold increase in the cost of R&D in this sector since 2010. The high cost of development and rapid obsolescence may prevent the transfer of technology and the patent holder may prefer direct exploitation or import of products over transferring the technology or know-how. Fear of competition also dissuades the transfer of technology or demands a high royalty for the transfer, but huge royalties may have a negative impact on the expenditure on R&D. In the case of India in the pre’70s era, technology transfer by the big MNCs did not support indigenous technological abilities, although post ‘70s, a large number of small and medium size firms have also been transferring their drug technologies to India, thus encouraging an atmosphere of competition in technology transfer. The Ministry of Science and Technology has issued the guidelines “Instructions for Technology Transfer and Intellectual Property Rights”, which would help in enhancing the motivation of scientists, research institutions and universities in projects funded by the Department of Science and Technology, Department of Biotechnology, Department of Scientific and Industrial Research and Department of Ocean Development. The salient features of the guidelines are limited to ownership,

commercial exploitation, royalty, norms for private industry, royalty free licenses for the government as well as patent facilitating funds. India at this point has an immense potential for becoming a booming ground to facilitate and nurture the benefits of technology transfer. However, there exists a dire need to address this with guidelines to govern the same. The goals of technology transfer will only truly be met and be expected to cater to the needs of the public if there is a greater involvement of the Government. Despite the above, Government of India is on the verge of opening Technology Transfer Offices, universities, institutions that will be funded by the Central Government and will act as mechanisms for transferring or exporting the research conducted and its outcome to the desired place. It is pertinent to note that some Indian institutes such as the National Chemical Laboratory, Pune, CSIR-CDRI, have already been commercializing their research and have been successful in entering into technology transfer agreements vide which they have been licensed as technologies to industry. It is only with adequate legal framework, guidelines and an increase of awareness that the issues of technology transfer can be encouraged. Although a number of Indian firms have been the receivers, a greater need of boosting this within the domestic markets is the need of the hour. References: Rosegger. G “The Economics of Production and Innovation: An Industrial Perspective” (Oxford: Butterworth-Heinemann Ltd), 1996, p. 155-156 h t t p s : / / w w w. i b e f . o r g / i n d u s t r y / pharmaceutical-india.aspx http://www.pfc.org.in/info/tt_ipr.htm

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Career in Pharmaceutical Management More Promising than Ever Before Pharmaceutical Management is one of the fastest growing and rewarding fields of Management Courses. Career in pharmaceutical management includes development, research, pharmaceutical administration and nursing.

ith the Pharmaceutical industry growing in double digits every year, there is plethora of career opportunities in the country. Few other sectors today are more lucrative and promising than the pharma sector which has witnessed over 17 percent annual growth from 2005 to 2016. The size of the industry is expected to be robust Rs 40,000 crore by 2020. With such fast growth of the industry, there is be equally fast growth in career avenues in the sector and youngsters with specialized education and training in the field can chart good growth for themselves in a relatively short span of time. A focused masters programme in pharmaceutical management, like MBA In Pharmaceutical Management is a course that deals with health, management and chemical sciences. MBA graduates in pharma work with these disciplines to ensure the safe and secure use of pharmaceutical drugs. Roles in Pharma Companies

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Those who wish to start their career after MBA in Pharmaceutical Management can join pharmaceutical companies in diverse roles like pharmaceutical sales, R&D, marketing, management, and related fields in capacity of Quality Assurance Manager, Drug Distribution Manager, Business Development Manager, Sales Manager, Marketing Research Analyst, or Marketing Manager etc. Experienced MBA graduates can get into post of Deputy General Manager or Regional Manager in reputed public sector pharmaceutical companies. Those who wish to study after an MBA degree can opt for higher studies

like doctoral level courses in field of Pharmaceutical Economics, Health Systems, Pharmacy Management etc. Starting Salaries The starting salary for MBA graduates in pharmaceuticals has gone up sharply in the past. The starting salary for an MBA (Pharmaceutical Management) is around Rs 4.5 to 10 lakh per annum but not restricted to that for good candidates. Good experience in this field can easily lead to a highly-paid job. It is important to note that those who start with high packages do not necessarily draw proportionately high salaries ten years later but if the selection of career path is right at the start, with a company of the right profile, then one can attain the satisfaction, good package and a senior position in the industry within short span of time. It is thus advisable that students give attention to the company profile, companyâ&#x20AC;&#x2122;s good-will, its market value and also their own long-term career plans. It is important to match the long term plans with the priorities of the company. There are a lot of opportunities for overseas placement also after completion of the course. The demand for Indian professional in the field in other countries because of various reasons like cost effective labour etc. Eligibility for MBA in Pharmaceutical Management The eligibility for the programme is basic graduation degree in Pharma or Science or Life Sciences. The admission process is quite rigorous for MBA programs of top universities. Numerous national Pharma Bio World

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level exams are conducted in various universities like Pharma MAT by IIHMR University, CMAT (Common Management Admission Test), GMAT, NMAT (Narsee Monjee Aptitude test). The entrance test is followed by group discussion and personal interview. The qualities that are judged through group discussion and interview are candidate’s ideas, expression ability, aptitude, attitude, decision making and critical thinking. There many colleges and universities which offer MBA program in pharmaceutical management. The prominent ones are the Indian Institute of Health Management and Research (IIHMR University), Jaipur, Narsee Monjee Institute of Management Studies (NMiMS University), Mumbai, Punjab, Indian Institute of Pharmaceutical Marketing, Lucknow, Jamia Hamdard University, New Delhi, Indian Institute of Management, Ahmedabad, National 30 ◄ February 2018

Institute of Pharmaceutical Education, and Research (NIPER), Indian Institute of Commerce and Trade, Lucknow etc. The sector is expected to grow faster with new policies and regulatory framework work. More and more international pharma companies are coming to India which further opens up avenues for these professionals. India has also started exports of pharma products to various countries and the list of such countries is only increasing. With more export opportunities for Indian pharma companies, there are even more options for a career in this field. Signs of Maturity by Indian Pharma Companies The pharma companies in India are showing signs of maturity and even new and patented drugs are being manufactured in the country. India is increasingly establishing itself as cost-effective manufacturing base for

bulk drugs, formulations and other products. As these companies will grow and mature, there will be need for professional management and hence youngsters can look at vast opportunities even in distant future. It is a matter of paramount importance to select the right avenue at the right time to make a successful professional career. Presently, the pharma-industry is in need of highly qualified technical, researchers, highly skilled, dynamic, effective managers who can take the company’s challenges forward by taking the complex decisions for the success and growth.

Contact: tanuj@teamworkpublicrelations.com Pharma Bio World

Continuing Innovation with Single-Use Technologies Adoption of single-use equipment is increasing at a rapid pace. Users started to embrace the available technologies over 10 years ago to reduce the cost in pre-clinical drug product manufacturing and clinical testing of new therapeutics and vaccines. Today, single-use equipment such as single use bioreactors are being adopted in cGMP suites and entire facilities are being converted to single use. The article will address how successful suppliers are responding to the need to provide higher quality product while continuing to innovate and produce approved molecules to meet the market demand.

lthough biopharmaceutical manufacturing has been pursued for just a handful of decades, bioprocess technologies have evolved dramatically. Optimization of cell-culture media and cell clones has led to dramatic increases in productivity. Manufacturing footprints have declined significantly; 20,000-L bioreactors (scale-up approach) have been replaced with 2000-L or multiple 2000-L single use bioreactors (scale-out approach).

with improvements in film robustness, were achieved.

These developments have enabled the adoption of single-use (SU) technologies across all scales, from research and development to clinical and commercial manufacturing. SU storage containers and mixers for non-critical applications have been in use for approximately 20 years. Their adoption in critical applications began a decade ago once drug manufacturers realized the myriad benefits afforded by SU technologies and equipment suppliers began to address concerns about waste management, extractables and leachables (E&Ls), and reliability of supply.

Stirred-tanks SUBs are proven to operate with the same mixing principles found in traditional stainless-steel reactors. With the broad adoption of SUT, users today are looking to optimize performance and reduce the footprint on cell-culture processes. One approach is to improve the performance of stirred-tanks SUBs through implementation of a higher 5:1 turndown ratio. Doing so allows users to eliminate equipment and consumables in their seed trains and thus achieve greater efficiency and cost savings.

The benefits of single-use bioprocessing include both cost and time savings. Because SU systems come presterilized, there is no need for cleaning, sterilization and related validation (or associated consumables for utilities and equipment) between runs, reducing setup and switchover times. Risk of crosscontamination in multi-product facilities is also minimized. Advances in SU Bioreactor Technology

Amit Chopra MD & VP/GM Thermo Fisher Scientific India and Middle East 32 â&#x2014;&#x201E; February 2018

Development of single-use bioreactors (SUBs) that are well-suited for commercial biopharmaceutical manufacturing was an initial focus of SU suppliers. Vendors collaborated closely with drug manufacturers to establish a range of bioreactors designs. Ease of use, power generation, and effective mixing, along

Today, single-use BioProcess Containers (BPCs) employed with SUBs are manufactured using specialty films engineered for bioprocessing in configurations to fit different frame designs for rocker and stirred tank bioreactors. SUB vessels are functionalized to enable mixing, venting, sparging, monitoring/ sensing, sampling, and liquid transfer.

In 2017, Thermo Fisher Scientific developed a novel cross flow sparger technology that makes it possible to achieve similar cell-culture performance whether running a bioreactor at 20% or 100% working volume. The bioreactor design is scalable for use in process development, clinical and cGMP manufacturing. Use of this 5:1 turndown ratio bioreactor allows employment of intensified seed trains with fewer vessels, reducing capital and operating expenses and accelerating development and scale up. The Story of Single-Use Sensors In addition to advances in bioreactor design, SU vendors have responded to the demand for single-use sensing technologies. Control of important process parameters, such as temperature, pH, Pharma Bio World

Figure 1: Equivalent performance of the new 5:1 turndown ratio SUB at different working volumes dissolved oxygen (DO), and mass transfer, is essential during cell culture to achieve the desired cell density, viability and expression rates. Approximately five years ago, single use pH and DO sensors were introduced to the market. Since then additional SU sensors for measurement of pressure, cell density and cell (bio) mass, concentrations of cell culture metabolites, and glucose have also been developed. The performance of these devices has improved over time, but further developments are needed to achieve more robust and reliable SU sensing technologies, particularly for determination of pH and metabolites. Single-use equipment manufacturers continue to work diligently to develop. Expansion across the Process Flow Chain The benefits of single-use technology are not restricted to upstream operations, and today a variety of SU solutions are available for downstream processing. In fact, most upstream and downstream unit operations in a biopharmaceutical plant can be performed reliably and costPharma Bio World

effectively in SU equipment. The â&#x20AC;&#x153;factory of the futureâ&#x20AC;? concept is based on the use of SU technologies across the process flow chain, including media preparation and storage, cell culture, harvesting, buffer preparation and storage, intermediate drug storage, viral inactivation, and final formulation and product storage. Advances continue to be made in the development of cost-effective SU solutions for inline buffer dilution systems, chromatography and ultrafilitration/diafilitration. Automation Improvements Another area of focus for SU vendors has been the development of effective control and automation systems for use with their SU technologies. Vendors have worked closely with software developers and device manufacturers to design robust and cost-effective solutions that provide ease of use combined with reliable operation. Different solutions have been developed for automation and control of non-GMP R&D and process development activities and clinical and commercial manufacturing, which require strict compliance with cGMP

guidelines. Different software platforms (Delta V, PLC, and others) have also been adopted by the industry. Automation and control systems are also elevating the cGMP manufacture of SU-systems to meet the demands of the biopharmaceutical industry. Implementation of semi-automated / automated manufacturing lines using HEPA-filtration has enabled the reduction of particulates during the production of SUTs. Standardization of BPC manufacturing with complete traceability has further ensured compliance with the highest quality levels expected. Vendors are currently challenged to expand automation and control systems beyond SU bioreactors to all upstream and downstream operations. Many biopharmaceutical manufacturers desire to implement manufacturing execution systems (MESs) such as SmartFactory that integrate all upstream and downstream unit operations and their associated automation systems. At present, however, there are only a limited number of players that can support the MES level of automation in the biopharmaceutical arena. February 2018 â&#x2013;ş 33

Making Modular Moves

Addressing Challenges

The needs of biopharmaceutical manufacturers today include reducing time to market, risk, and investment in infrastructure for clinical manufacturing while also producing their products locally. Smaller, flexible, multi-product manufacturing plants that can be replicated in multiple locations around the world are therefore needed.

Initial concerns about E&Ls have been addressed through the development of high-performance, engineered films for the production of biocontainers, tubing, connectors, and other SU components.

Modular facilities with single-use technologies are increasingly seen as the answer. It takes as little as 50% of the time to build a modular vs. a traditional stainless-steel plant depending on the size and specifications.4 Modular facilities would not, however, offer the time and cost benefits they do without the deployment of single-use technologies. Facilitating Continuous Manufacturing Like modular facilities, continuous bioprocessing is viewed as a way to increase the efficiency and reduce the cost of biopharmaceutical manufacturing. It can also result in quality improvements and reduced environmental impacts, which has led FDA to strongly encourage its implementation.5 There is growing interest in the biopharmaceutical industry, and a number of products are under development that will be produced in the next 3-5 years using continuous processing. This move is challenging SU suppliers. Continuous bioprocesses can operate for weeks or months, and the product contact time with the SU biocontainer film increases significantly. There is a need for highly reliable and robust SU systems with long-term acceptable E&L profiles. Furthermore, because realtime process control and monitoring are crucial to achieving consistent steadystate conditions, there is greater pressure on SU suppliers to develop robust and reliable SU sensor solutions for the measurement of process parameters. 34 â&#x2014;&#x201E; February 2018

Initial guidelines on E&Ls were introduced by the single-use suppliers and biological manufacturers group BPSA (Bio-Process Systems Alliance). A group representing biopharmaceutical manufacturers (BPOG, the BioPhorum Operations Group) and the American Society of Mechanical Engineers (ASME) have since introduced their own guidance materials. Additional guidelines on single-use processing are expected to be released by the US Pharmacopoeia and ASTM International. Due to the lack of a unified approach, SU suppliers are expected to comply with all of these varying regulations and guidelines. The testing required is expensive, and it remains questionable as to who will fund the testing required to comply with these regulations. Similarly, standardization is needed for both biological manufacturing processes and SU solutions on the supplier side. BPOG and BPSA have initiated efforts in this direction, but much remains to be achieved in the next three to five years. Every bioprocess is unique with unique requirements. One standard set of equipment will therefore be insufficient, and customization will always be necessary. Intellectual property concerns must also be addressed.

or manufacturing facilities of the same supplier with no overlap in their supply chains that offer equivalent materials with respect to both their physicochemical properties and their functional performance. Few SU suppliers at this point have elected to invest in redundant manufacturing facilities to provide the desired level of assurance of supply. Moving forward on this issue requires sharing of all stakeholder perspectives and will be a slow process. Innovation is No Longer an Option The numerous benefits realized with the implementation of SU technologies clearly outweigh the challenges associated with their use. SU systems have been adopted in every area of biopharmaceutical manufacturing: r-protein and monoclonal antibodies, vaccines, human/animal blood products, cell- and gene-therapies, and personalized medicines. SU technologies will in fact be essential to the successful commercialization of nextgeneration treatments. As the demand for SU technologies increases with time, suppliers of single-use technologies must continue to innovate to expand the applicability of SU systems across all bioprocessing unit operations â&#x20AC;&#x201C; batch and continuous and improve the performance of their products, while also investing to enhance the assurance of supply.

BPOG and BPSA are also working to alleviate concerns regarding the need for the dual supply of SU technologies. Due to the widespread use of SU technologies in both upstream and downstream bioprocessing, SU systems have become critical components of biomanufacturing. SU suppliers need to mitigate the risk associated with this aspect of the supply chain. Dual sourcing requires the identification of two completely independent suppliers

Contact: seema@mediavalueworks.com Pharma Bio World

news features

Union Budget 2018: Reactions from the Indian Pharmaceutical Industry

he Union Budget 2018 was presented on February 1, 2018. Here is how industry experts and leaders from across the pharmaceutical and healthcare sector reacted to Finance Minister Arun Jaitley’s Budget.

“The government’s focus on rural development and agriculture is a welcome step. The long overdue emphasis on our rural economy and agriculture will stimulate demand. The announcement of the Aayushman Bharat program for healthcare is a game changer and the coverage of ten crore people under the National health protection scheme is commendable. This will give an impetus to healthcare benefits for people in the most deserving sections of society. Overall, while the budget appears to be a progressive one, it was disappointing to note that the reduction in corporate tax was offered only to companies with a turnover under of ``. 250 crores”

Satish Reddy Chairman Dr. Reddy’s Laboratories

“We were optimistic about the budget this year and the Hon’ble Finance Minister has presented a budget that meets our expectations. The budget has addressed key areas that will help the economy grow in the coming year. The main concerns of the healthcare sector have been taken into consideration and initiatives under “Ayushmann Bharat” to insure and protect the poor will move the country towards universal health coverage. Establishing of health and wellness centres in rural and smaller towns will Surajit Chakrabartty CFO Medgenome

make healthcare more accessible and affordable for the larger population. These are good measures and we are confident that they will usher in a new era of social health equity in the country and take us a step closer towards inclusive social security.”

“Overall, this has been a pro-people and a pro-poor budget. For the first time, Universal Health Care has got the impetus it needs. I am quite happy with the government’s plan to introduce 24 new medical colleges. That is the only way to address the glaring lack of talent in the industry. The 1.5 lakh centres which will provide free essential drugs and diagnosis is a welcome move and a step towards boosting the Government’s National Health Policy. The flagship national healthcare protection scheme which will cover 10 crore, underprivileged families, is a highly commendable initiative. Through the budget, the government has definitely shown its interest in making healthcare more accessible and affordable through the Ayushman Bharat programme. Another highlight of the budget has been the focus on fighting the ever-growing hazards of pollution from crop burning, promotion of gas connection in houses using wood fire for cooking, among others. By not just talking about healthcare, but its indicators as well, the government is definitely on the right track towards improving the sector across the country. We truly hope that going forward, the government also has plans for utilisation management, financial monitoring, audit mechanisms and accountability”. 35 ◄ February 2018

Ameera Shah Promoter and Managing Director Metropolis Healthcare Ltd

Pharma Bio World

news features

Debayan Ghosh Founder & President Epygen Biotech Pvt Ltd

“Fueled by the ` 1200 Cr allocation for healthcare, what is exciting is the 1.5 lakh new healthcare centers that are going to be initiated. For a country that presents the highest number of patients in area of Breast Cancer and Head and Neck (Oral) Cancer cases in the world, these centers needs to be equipped with primary Onco scanning and treatment options. An early detection and treatment option would reduce healthcare cost burden on the Indian exchequer by several thousand crores in terms of disability adjusted life years (DALY). Biotech industry expectations for dedicated research funds in the area of Biosimilars development and Regulatory Ecosystem remains unattended. India definitely requires financial focus to ramp up this area and craft out its position in the world healthcare scene”.

“The 2018 Union budget looks positive for the healthcare sector. With this health protection scheme, most of the health needs of the low-income group will be taken care of. In my opinion, the budget should have given some preference to health screening as well so that a culture of prevention could have been created. Government is focusing more on NCDs, which mostly show symptoms at the end stages, hence treatment becomes difficult and expensive. The setting up of 1.5 lakh new health and wellness centres is also a good decision however strengthening the preventive healthcare sector would have lowered the NCDs burden and treatment cost. This would also help in reducing health expenses of the country as a whole. Even if a small budget was allocated to preventive health checkups, the NCDs would receive cure at the initial stage and the treatment cost would lessen. Addressing prevention at a larger level like the curative measures would lower the out-of-pocket-cost for the population that isn’t covered under the scheme.” Srinivasan H R Managing Director and Vice-chairman TAKE Solutions

“The Union Budget 2018 has taken a huge step in making healthcare affordable and accessible by launching the world’s largest government-funded healthcare programme. The initiative to cover 100 million families with INR 5 lakh per family annual insurance cover is a welcome change. More exposure of the healthcare industry value adds to the Life Sciences sector which will boost the growth of the sector. The government’s proposed R&D investments in futuristic technologies - artificial intelligence, robotics, big data are sure to be a game changer to our industry.”

“This step (allocation of ` 1200 crore towards Health and Wellness Centres) will significantly help in combatting one of the biggest challenges in healthcare in India today, which is the rising burden of Non-communicable diseases (NCDs). NCDs such as diabetes, cancer, and heart disease contribute to 61% of all mortalities every year in our country, and the WHO estimates that these will cost India almost USD 5 trillion by 2030. This budgetary allocation for the prevention and treatment non-communicable diseases will be a critical step to stem the tide now. Furthermore, the launch of the National Health Protection Scheme is another vital move for achieving universal healthcare in India. In the last decade, we have watched our neighbor, China, successfully expand its UHC from a negligible number to 900 million citizens (95% coverage). A 5 lakh benefit / family for both primary and secondary healthcare, as long as its covering the wide range of healthcare issues and costs that it promises to be, is a huge boost by the government to provide the necessary impetus for India to achieve that rate of coverage. Proactive steps like this by a forward-thinking government can help enablers in healthcare to win the war against the disease burden in our country.” Nilaya Varma Partner and Head Government and Healthcare KPMG India

Abhishek Shah Co-Founder Wellthy Therapeutics

“NHPS rollout will need effective gatekeeping system with an immediate focus and strengthening of primary care services in the country. Gatekeeping systems will ensure equity by judicious referral system to secondary & tertiary care”

“It is heartening to see the increased focus by the government in improving healthcare infrastructure especially with focus of Prevention and Early diagnosis. Along with increased outlay for healthcare, 5 lakhs insurance coverage for 10 Cr families, access to CSR funds and increased focus on PPP programs healthcare sector should see a never seen new momentum next year”. 36 ◄ February 2018

Amol Naikawadi JMD Indus Health Plus

Dr. GSK Velu Chairman Neuberg Diagnostics

Pharma Bio World

marketing initiative

Antistatic Silicones: Playing Vital Role in Food and Pharma Industries

ow a days Food and Pharmaceutical industries are facing many issues regarding safe processing operations. Major processing steps involved in drug manufacturing and delivery system are of having dynamic mechanical movements. Dynamic movement of machines generate static electricity charge on the surface of components. Silicone is most widely used polymer in pharma industries for fluid delivery and sealing application. Naturally Silicone rubber is having insulating properties in nature. Developed static electric charges on polymer surface can be reason of fire while contact with flammable processing solvents. Many fire incidents happened in last few years because of this reason.

Before understanding antistatic silicone in detail, it is required to know basic about terminologies related to conductivity. Material can be categorized as per its conductivity of electric charge.

conductivity depends upon concentration of additives in silicone matrix. Though it is very challenging job to develop as these additives may affect the chemical properties of silicone. Like food grade and Pharma grade properties may alter.

103 To 105

105 To 109

109 To 1011

> 1012

Conductive

Dissipative

Anti-Static

Insulative

Increasing

Conductivity

. Silicones and other polymers fall under Insulative category. There are certain additives available in market which imparts conductivity in silicones. Extent of

TYPES OF FOOD AND PHARMA GRADE APPLICATIONS

Decreasing

Let understand the case through below example: Consider a fluid DCM is flowing though silicone tubing with peristaltic pump RPM of 300. Over a period of time static electric charge gets developed on inner surface of tubing. Boiling point of DCM is 40°C and it is flammable in nature which can generate fire on exposure of static electricity charge. It is matter of challenging job to produce antistatic and static dissipative silicone with achieving below compliances: FDA 21 CFR 177.2600- Food grade test USP CLASS VI- Biological reactivity test ● ISO 10993 – Biocompatibility test Polymer industries are developing colored antistatic and static dissipative silicones. Generally black colored Polymer products rarely in demand for pharma industry. It is all about art of compounding to achieve electrical properties with variety of color possible like green, blue, yellow, grey etc. It is expected that within coming years antistatic silicone products will replace the market of general silicone products for dynamic applications. ● ●

•

Silicone Tubing for Solvent Transfer from peristaltic pump

•

Continuous motion of fluid generates static electricity charge on surface silicone tubing. Flammable fluid may catch fire due to developed electric charge.

•

• •

Silicone bellow is used in pharma industries for power transfer. Vibratory action results electric charge development on surfaces which is dissipated by antistatic properties of silicone rubber

Pharma Bio World

• • •

Silicone/Rubber hoses are used in pharma industries as a part of drug delivery system. High floe rate of fluid may generate static electric charge on inner liner. Antistatic silicone liner prevents charge development on liner surface.

• •

Silicone Sifter sieves as used to filter the tablet fine powder for effective particle size distribution. Static electricity charge developed by Vibratory action of machine is compensated by Electrically static dissipative silicone molding.

  Vinay Pandey (B- Tech Rubber Technologist) Ami Polymer Pvt. Ltd. Tel +91 8691013936 tech@amipolymer.com February 2018 ► 37

marketing initiative

Sifter Sieves

sieve or sifter, is a device for separating from

wanted

unwanted

elements

material

for characterizing the particle size distribution of a sample, typically using a woven screen such as a mesh. Sifting is mainly used in two areas, Check

screening

raw

material

to remove extraneous material and Sizing to sort, segregate or control the particle size distribution of powders and

granules.

Sifting

mainly

achieved by used of vibratory, rotary & centrifugal screeners. Characteristics: ●

Sieves have to be specially designed to resist the high tensile stress generated.

Since

particle

size

distributions plays a vital part in drug dissolutions, maintaining the accuracy of the sieves apertures in

essential

part

sieves

manufacturing. ●

Proper thickness of wire, accurate

●

nominal apertures sizes, high tensile

transparent in appearance.

strength and tautness of the sieves are essential part of sieve for high

●

Material of construction Stainless Steel – 316 and 316L.

●

Applications:

Aperture sizes – 4075 to 70 microns or mesh sizes 4# to 200# with ASTM standard being certified 90X microscope.

●

Nontoxic & molded on the stainless steel ring.

sifting performance. ●

The silicone is food grade material,

Sieves are available in various sizes from 4” to 30” diameter. The most common size used 20” (550mm) & 30” (750mm) diameter.

38 ◄ February 2018

●

Pharmaceutical Industries

●

Food Industries

●

Used in Vibro-Shifter Machine

●

Chemical Industries

   Ami Polymer Pvt. Ltd. 319, Mahesh Industrial Estate, Opp. Silver Park, Mira-Bhayander Road, Mira Road (E), Thane - 401104, Maharashtra. INDIA Tel.: +91 22 28555 107 / 631 / 914 | Cell: +91 86910 13935 Email: mktg@amipolymer.com Web: www.amipolymer.com Pharma Bio World

marketing initiative Case Study

HMX-Ambiator Helps Himalaya Prevent Degradation of Raw Materials Company background The Himalaya Drug Company is a leading multinational medicinal drug company. It produces health care products under the name Himalaya Herbal Healthcare. It has grown multifold and is spread across locations in India and abroad. Today, the Himalaya brand is synonymous with safe and efficacious herbal products; their products are prescribed by 400,000 doctors worldwide, and millions of customers trust them for their health and personal care needs. The challenge Himalaya’s revamped state-of-art factory in Bangalore commenced operation in

2006 and is spread over 200 acres. Its production block 2, raw material section, comprises an area of approximately 13,000 ft2 (PB2 RMS), where the herbal/ayurvedic medicine in the form of granules/powder or liquid is stored before taking it into production. This space was only ventilated and the temperature usually soared above 35°C in the summer. Generally when the temperature crosses 30°C, the raw material turns lumpy which then has to be rejected The solution This is when the Himalaya management approached HMX for its IDEC system. The requirement was that the temperature in

any weather should not cross 30°C. HMX then carried out a comprehensive heat load study and based on the calculated room sensible heat gain, assumed delta T of 5°C-6°C (difference between room temperature and grill temperature) it was estimated that 30,000 CFM of dual stage evaporative cooled air would be adequate even in the worst condition to ensure that the space temperature does not cross 30°C. This was re-checked with the ideal number of air changes and it was found to be in line with industry standards. Himalaya then invited HMX to supply 2 x 15,000 CFM machines totaling to 30,000 CFM. Also, Himalaya wanted to continue with the existing ducting as it was relatively new and changing the same would obstruct the factory working. The HMX team then executed the project keeping the same ducting without any interference in factory working, with successful air balancing. The result The HMX-Ambiator was commissioned last October and has successfully passed the 2014 summer. The temperature has never crossed 28°C since then. Earlier on an average more than 2 tons out of a storage capacity of 20 tons base medicines used to invariably get degraded and rejected. This has now been totally eliminated. The management at Himalaya is delighted with the results. The store manager at the factory said “We are extremely satisfied with the performance of HMX units. Earlier more than 10% of the raw material used to be rejected due to temperature spikes; now due to control of temperature there is zero rejection.”

15000 CFM HMX-Ambiator installed at Himalaya’s Bangalore plant Pharma Bio World

   A.T.E. ENTERPRISES PRIVATE LIMITED Tel: +91 - 80 - 2372 1065 / 2372 2325 E-mail: ambiator@hmx.co.in www.hmx.co.in / www.ateindia.com February 2018 ► 39

marketing initiative

Novartis India Limited Reconstitutes Board; Appoints Jawed Zia as Vice Chairman & Managing Director At a meeting held in Mumbai, the Board of Directors of Novartis India Limited announced the appointment of Jawed Zia as Vice Chairman & Managing Director effective March 01, 2018. Jawed Zia is currently Head Pharmaceuticals, Novartis India Limited. He has a wealth of experience gained in various geographies and functions in the healthcare sector across the globe. Having joined Ciba-Geigy in 1987, he has had a successful career history working across Pharmaceuticals, Consumer Health and Devices in positions of increasing responsibility in various functions of Market Research, Brand Management, Marketing Management,

Division

Management

and

Area

Management in Ireland, Saudi Arabia, Turkey, Singapore, Canada, Switzerland and now in India. He set up and led the Alcon business in India from 2004 to 2012; he moved to a regional role in Alcon in 2012 following which he joined Novartis India Limited in June 2014 as Head Pharmaceuticals. Mr.

Zia

graduate

Clinical

Pharmacology from All India Institute of Medical Sciences, New Delhi and holds an MBA from Trinity College, Dublin (Ireland). He succeeds Ranjit Shahani who holds this position until February 28, 2018.

Novartis India Media Relations Svetlana Pinto +91 22 2495 1074 (direct) +91 98210 54884 (mobile) svetlana.pinto@novartis.com Liana Albuquerque +91 22 2495 8805 (direct) +91 98214 36458 (mobile) liana.albuquerque@novartis.com    Novartis India Limited Novartis India Communications Registered Ofﬁce: Sandoz House Shivsagar Estate Dr Annie Besant Road, , Worli Mumbai 400 018

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The pharmaceutical industry has grown over the years, and this has made the case for the ever growing expediting shipping and logistics challenges. Finding the best logistics companies have been a major challenge in this industry. Although there are many types of industries that require logistics services, various issues contribute to this pitfall of the pharmaceutical industry. As with most other packaged goods, pharmaceuticals need reliable and speedy packaging solutions that deliver a combination of product protection, quality, tamper evidence, patient comfort and security needs. Constant innovations in the pharmaceuticals themselves such as, BFS vials, anti-counterfeit measures, PICVD)coating technology, snap off ampoules, unit dose vials, two-in-one prefilled vial design, prefilled syringes and child-resistant packs have a direct impact on the packaging. This issue of Pharma Bio World will be addressing the recent pharmaceutical packaging and logistic trends that are impacting packaging industry in the pharmaceutical industry.

To ensure Pharma Bio World continues to meet your needs, we would appreciate your feedback. Please feel free to write to us at mahesh_kallayil@jasubhai.com if you think we can serve you better.

40 ◄ February 2018

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marketing initiative

B&R steps up efforts advancing OPC UA

Automation specialist appointed to OPC Foundation’s Technical Advisory Council

&R is now represented in the OPC Foundation’s Technical Advisory Council (TAC). This move further strengthens B&R’s role in the strategic advancement of the OPC UA standard. Appointment to the TAC is a tribute to B&R’s committed involvement throughout numerous OPC Foundation working groups. Drawing its membership from the likes of Microsoft, SAP, Rockwell and Siemens, TAC is the highest tech-nical body within the OPC Foundation. The council

is tasked with setting the strategic course for advancing OPC UA in a way that maximizes user benefits. It has the authority to establish technical working groups and approve new OPC UA specifications. Pub/Sub and TSN B&R will be represented in the TAC by Dr. Dietmar Bruckner. As Technical Manager of Open Automation Technologies at B&R, Dr. Bruckner is responsible for all development activities surrounding

Dr. Dietmar Bruckner represents B&R on the OPC Foundation’s Technical Advisory Council. Pharma Bio World

OPC UA TSN. “I’m very much looking forward to working in the TAC,” he says. “Together, we will make rapid progress in the development of Pub/Sub and TSN. In combination with application-specific OPC UA companion speci-fications, we will very soon be able to offer a uniform standard for seamless communication from the sen-sor to the cloud.” 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 technol-ogy 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 industri-al automation is driven by a commitment to simplifying processes and exceeding customer expectations.

For more information Corporate Communications t +43 7748 6586-0 press@br-automation.com B&R Industrial Automation B&R Strasse 1, 5142 Eggelsberg, Austria visit www.br-automation.com. February 2018 ► 41

marketing initiative

POWERLINK now IEEE 61158 standard Only Industrial Ethernet protocol to be adopted by IEEE

POWERLINK has been adopted by the IEEE under international standard IEEE 61158. It is the only Industrial Ethernet protocol to achieve this status. The IEEE views its standards for TSN and POWERLINK as core components for real-time industrial communication. The Institute of Electrical and Electronics Engineers (IEEE) is the world’s largest professional association in its field. Among its most prominent accomplishments is the IEEE 802.3 standard commonly known as Ethernet. The IEEE’s industrial real-time communication working group has been working for the past two years on the definition of an Industrial Ethernet standard. In March 2017 POWERLINK

was adopted as the sole IEEE standard with 97% of the vote. Unrestricted openness “Real-time industrial communication had previously been a gap for the IEEE,” explained Dr. Victor Huang, responsible for standardization at the IEEE Industrial Electronics Society (IES) following the vote. “With its combination of high performance and unrestricted openness, POWERLINK is the perfect complement to the other IEEE communication standards.” “The adoption of POWERLINK as an IEEE standard is an important step toward standardizing industrial automation technology at the field level,” added Prof. Aleksander Malinowski, IEEE Industrial Electronics Society (IES) Senior AdCom Member.

EPSG Managing Director Stefan Schönegger sees great potential for POWERLINK as an IEEE standard, particularly in combination with another IEEE-development: TSN technology. “In every aspect of global industry, openness has a way of winning out.” About the EPSG The Ethernet POWERLINK Standardization Group (EPSG) is an independent organization founded in 2003 by leading companies from the fields of motion control and automation technology. Its aims are the standardization and further development of the POWERLINK protocol first introduced by B&R in 2001. This highperformance real-time communication system is an advanced protocol based on the IEEE 802.3 Ethernet standard designed to ensure real-time data transfer in the microsecond range. The EPSG cooperates with leading standardization organizations such as CAN in Automation (CiA), the OPC Foundation and the IEC.

For more information, Ethernet POWERLINK Standardization Group (EPSG) POWERLINK OFFICE Bonsaiweg 6 15370 Fredersdorf Germany Tel.: +49 . 33439 . 539 270 Fax: +49 . 33439 . 539 272 42 ◄ February 2018

Pharma Bio World

press release Eli Lilly Appoints Luca Visini MD for its Operations in India Multinational biopharmaceutical leader, Eli Lilly and Company, announced earlier this year the appointment of Luca Visini as Managing Director of its Indian subsidiary, Eli Lilly and Company (India) Pvt. Ltd, effective February 1, 2018. Visini replaces Edgard Olaizola, who headed Lilly India operations from September 2013 to January 2018 and will now be moving internally to a new role. Visini joined Lilly in 2004 and held several strategic leadership roles in various functional departments out of Lilly headquarters in Indianapolis, the USA and Europe. From 2011 to 2014 he was the country manager for Lilly Romania. He is taking this executive role endowed with a diverse and solid management experience at Lilly. Visini is a native of Italy, and an alumnus of SDA Bocconi School of Management and Università degli Studi di Bergamo in Italy.

Sanofi Launches New Insulin Toujeo in India Sanofi India continues to deliver breakthrough medicines for the management of diabetes with the launch of its new product - Toujeo, the next generation basal insulin. Toujeo is a once-daily, long-acting basal analog insulin that improves glycemic control in adults with type 1 and type 2 diabetes. Low blood sugar, or hypoglycemia is a constant fear amongst people on insulin. Toujeo has demonstrated that it effectively lowers blood glucose, while minimizing the risk of hypoglycemia. It works by slowly releasing small amounts of insulin to provide continuous glucose-lowering activity that lasts beyond 24 hours. With its stable and flat/peak-less action profile, Toujeo reduces glycemic variability, i.e. the daily highs and lows that people with diabetes on insulin may experience. The product also comes with an impressive MY COACH patient support program (offered free to patients prescribed Toujeo). This patient support program provides six comprehensive months of hand-holding patients through their treatment journey - tips on diet and lifestyle, training on injection techniques, sugar monitoring and more, via a mix of telephonic and in-person sessions. MY COACH will be offered under Sanofi’s Saath-7 initiative, the longest running patient support program in India, which has serviced more than 4,12,000 people with diabetes on insulin till date.

IPA Conducts Training Sessions at IPC The National Coordination Center (NCC) for Pharmacovigilance Programme of India (PvPI), Indian Pharmacopoeia Commission (IPC) under the Ministry of Health & Family Welfare, Government of India, Ghaziabad, Uttar Pradesh (U.P.) organized Skill Development Programme (SDP) on “Basics and Regulatory Aspects of Pharmacovigilance – Optimising Medicine Safety is our Goal” from January 15-24, 2018 at Conference Hall of IPC, Ghaziabad. The Pharmacovigilance (PV) programme is conducted every year to accomplish SDP in the country under Pharma Bio World

the government’s ambitious Pradhan Mantri Kaushal Vikas Yojana. The objective of the workshop was to enhance the knowledge and skill of qualified PV professionals to ensure better patient safety as per the requirement of Schedule Y of Drugs & Cosmetics Act, 1940 and to enhance career prospects & employment opportunities in PV in government as well as in private sector. The target group for the programme was young pharma / medical / paramedical professionals seeking career in PV and existing professionals in PV. Faculties drawn for the programme were renowned experts from government teaching & corporate hospitals, regulatory authority, WHO, pharmaceutical industry, academia and research institutions.

Dr. Reddy’s Launches Tetrabenazine Tablets in the US Market Dr. Reddy’s Laboratories Ltd has launched Tetrabenazine Tablets, a therapeutic equivalent generic version of Xenazine (tetrabenazine) in the United States market approved by the US Food and Drug Administration (USFDA). The Xenazine brand and generic had US sales of approximately USD 322 million MAT for the most recent twelve months ending in November 2017 according to IMS Health. Dr. Reddy’s Tetrabenazine Tablets are available in strengths of 12.5 mg and 25 mg, each strength is available in a bottle count size of 112. Xenazine is a registered trademark of Valeant Pharmaceuticals Luxembourg S.A.R.L.

Premas Life Sciences, IncellDx Sign Distribution Deal Premas Life Sciences Pvt, Ltd and IncellDx, Inc have signed an exclusive distribution agreement. The commercial partnership brings the power of cell by cell multiplex diagnostics for solid tumors carcinomas that can now be analyzed for molecular and protein biomarkers by flow cytometry. Included in the deal are: IncellDx’s patented single-cell assays for quantifying PD-L1 on tumor cells and immune cell subtypes; patented single-cell assay for HPV E6/ E7 mRNA detection in cervical samples; and, its incellPREP singlecell preparation kit for solid tissues including tumors. Researchers at AIIMS, New Delhi have completed a successful study utilizing IncellDx’s next generation (3Dx) investigational molecular assay which quantifies E6, E7 mRNA overexpression in single cells simultaneously with the measurement of cell cycle and cell proliferation, the hallmark of progressive disease. IncellDx is a molecular diagnostics company dedicated to revolutionizing healthcare one cell at a time. By combining molecular diagnostics with high throughput cellular analysis, the company’s focus is on critical life threatening diseases in the areas of cancer, specifically lung, cervical, head and neck, bladder, cancers. February 2018 ► 43

press release LifeCell Initiates Development of Large Scale Manufacturing of MSCs

Advisory Group of Experts (SAGE) on Immunization in April 2017 has recommended at least 2 doses of IPV in the routine Immunization schedule of the countries post OPV withdrawal.

LifeCell, India’s first & largest stem cell bank in the country, a pioneer in stem cell research has embarked on a journey to develop large scale manufacturing of Mesenchymal Stem Cells (MSCs).

Lupin Forays into OTC Segment with Softovac

Mesenchymal Stem Cells are one type of master stem cells that have the potential to form bone, cartilage, muscle and adipose tissues, thereby making them capable of being used in the several therapeutic areas. Importantly these MSC’s can be made available off-the-shelf for immediate treatment as they don’t need donor-recipient matching. The potential of these MSCs of medical conditions are being checked in 50+ clinical trials around the world, with several companies like TiGenix, Mesoblast, etc., are also receiving market approvals in many countries such as Europe, Canada, Japan, and Australia. Even in India recently, the DCGI provided a limited approval to Stempeutics to market their MSC product for treatment of Critical Limb Ischemia.

Historic Deal Signed Between Panacea Biotec & Serum Institute of India Panacea Biotec Ltd. (PBL) is delighted to announce the collaboration with signing of two long term agreements with Serum Institute of India Pvt. Ltd. (SII) and SII’s wholly owned subsidiary, Bilthovan Biologicals B.V. (BBIO). Under the collaboration SII is entitled to manufacture & sell fully liquid Whole cell Pertussis (wP) and Salk based Injectable Polio Vaccine (IPV) based Hexavalent vaccine (DTwP-HepB-Hib-IPV) developed & commercialized by Panacea Biotec, a first of its kind in this category. WHO prequalified IPV is essential to successfully eradicating Polio across the globe, an effort that has already cost USD 20 Billion worldwide. There is a Global Polio Eradication Initiative (GPEI) in place & Global Alliance for Vaccine Initiative (GAVI) has been supporting the program since 2013 having allocated USD 430 Million till 2018 with an additional donor pledge of USD 23 Million for 2019. At present GAVI is evaluating IPV under Vaccine Investment Strategy for Global Public Good. Global demand of IPV/ IPV containing vaccines is estimated to rise significantly from ~100 Million in the year 2020 till supply constraints remain, to 250-350 Million doses every year starting 2022 depending upon a two or three dose schedule as Strategic 44 ◄ February 2018

Pharma major Lupin Limited (Lupin) has made a foray into the over-the-counter (OTC) segment under the ‘Lupin Life Consumer Healthcare’ umbrella with the pan-India launch of Softovac. A 34year old legacy brand, Softovac has been trusted by millions of consumers who suffer from constipation and irregular bowel habits. Pegged at over USD 2.7 billion (INR 18862 crores) as on 2016 as per Nicholas Hall 2017 report , the Indian OTC market is expected to grow at a CAGR of 9 percent to cross the USD 6.5 billion (INR 44115 crores) mark by 2026. Softovac’s shift to OTC was piloted in West Bengal during which the brand witnessed a growth in sales of over 25 percent, and post the success of the pilot, a pan-India roll-out was initiated. Softovac is a bowel regulator made with 100 percent natural actives like Isabgol, Sonamukhi, Harad, Mulethi, Gulab dal (ingredient), Amaltas, and Saunf, all of which are time-tested ingredients known to provide effective relief from constipation and irregular bowel habits.

Evofem Biosciences Completes Enrollment of Amphora Phase 3 Trial Evofem Biosciences, a biotechnology company developing innovative products to fill women’s unmet healthcare needs, announced early completion of enrollment in its phase 3 clinical trial evaluating Amphora (L-lactic acid, citric acid, and potassium bitartrate) vaginal gel for the prevention of pregnancy. Clinical trial data is expected in the first quarter of 2019. This single-arm, open-label, multicenter, phase 3 clinical trial enrolled over 1,350 women aged 18-35 at risk of pregnancy at over 100 centers in the United States. The primary endpoint of the study is the contraceptive efficacy of Amphora over seven cycles of use. Amphora is concurrently being evaluated in a double-blinded placebo-controlled phase 2b/3 trial of Amphora for the prevention of urogenital chlamydia and gonorrhea in women. This sexually transmitted infection (STI) trial, which announced first patient enrollment on January 23, 2018, is designed to enroll approximately 850 women at up to 20 centers in the United States. Patients will be on-study for a four-month interventional period and subsequent one-month follow-up period. Pharma Bio World

Tube Filling, Crimping & Batch Coding Machine The semi-automatic eight station aluminium tube filling, crimping and coding machine is sturdy and compact in design and simple in operation. It consists of an aluminium rotating disc with interchangeable tube holding sockets for different tube sizes. All operations are completely automatic except the feeding of the tubes. One operation can fill 25-30 tubes in single head and 55-60 tubes in double head per minute. The machine is compact, elegant and auto switch-off system if tubes are not placed properly. Tailing controlled by air flash, automatic ejection, suitable for all standard tube sizes. For more information, please contact: Pharma Chem Machineries 311/2484 Motilal Nagar No: 2 M G Road, Goregaon (W) Mumbai 400 080 Telefax: 022-28735321 E-mail: pharmach@gmail.com

Laminated Tube Filling & Sealing Machine Semi-automatic twelve station laminated tube filling and sealing machine is sturdy, compact, and easy to operate, consist of a rotating disc with interchangeable different types of tube holding sockets. Features SS plain hopper for 25 kg capacity and has volume track for setting fine volume adjustment and accuracy; interchangeable hot air blowing nozzles for different tube provided optional; batch coding provided in the sealing station.The machine is covered with SS-304Q steel and the contact parts if required can be provided in SS-316Q. Output for single head machine is 30-35 tube per minute/double head machine 60-70 tube per minute. For more information, please contact: Pharma Chem Machineries 311/2484 Motilal Nagar No: 2 M G Road, Goregaon (W) Mumbai 400 080 Telefax: 022-28735321 E-mail: pharmach@gmail.com

21 Suncoater/Auto Coater Suncoater is an automated tablet coating system for efficient film coating of tablet cores with GMP compliance in closed condition. The main unit consists of a cylindrical perforated pan with conical ends in a SS double-walled enclosure. Tablets are changed into the pan for coating. Coating fluids are sprayed through multiple air atomizing spraygun(s) mounted strategically in the pan. A peristaltic pump is employed for precise delivery of coating fluids. The tablet bed is gently and efficiently mixed with the aid of mixing baffles attached inside the pan. The coated tablets are dried with dehumidified heated and filtered air supplied from an inlet AHU having 10 and 5 micron prefilters, dehumidification and heating system followed by 0.3 micron HEPA filters. As a result applied coating is dried with non-contaminated, dustfree and optimized volumes of air producing uniformly coated tablets. For more information, please contact:

Sunsai Pharma Equipments Pvt Ltd Plot No: 1, Survey No: 77 Nr Laxmi Indl Estate Sativali Road, Vasai (E) Maharashtra 401 208 Tel: 0250-3200130 E-mail: sunsai.pharma@rediffmail.com / sunsaipharma@gmail.com

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February 2018 â&#x2013;ş 45

Sigma Mixer Kneader/Extruder The Sigma 2 blade mixer is used for mixing and kneading of high viscous mass, sticky or dough like paste, gum, rubber, adhesive application in the food and pharma, adhesive, plastic and pesticides industries. It is available in 10 to 1,500 litre working capacity. W-shape container with double 2 blade with different speed for kneading combined action of bulk movement, stretching, folding, dividing and recombining of high viscous materials.

For more information, please contact: Prism Pharma Machinery Plot No: 3713, Phase IV, GIDC Vatva, Ahmedabad Gujarat 382 445 Tel: 079-29095204 Fax: 91-079-25841623 E-mail: mkt@prismpharmamachinery.com sales@prismpharmamachinery.com

Magnetic Impellers Open design with excellent cleaning hub and magnetic rotor are connected only by the impeller blades. The ceramic bearings are oversized in dia and height, product lubricated and consists of outer (silicone carbide) and inner (zirconium oxide) bearing. This results in exceptional stability, good emergency running properties and particle generation below detectable levels. Ease of maintenance â&#x20AC;&#x201C; ceramic bearing parts can be replaced by users on site; no spare rotor needed. A large gap between the rotor and the contaminent shell maximises flow through the gap and minimises share stress. CFD-engineered mixing, fluid is drawn from above and pumped radially. Perfect for mixing solid powders into liquids; rapid break down of temperature and concentration gradients, ensures good heating and cooling. New and stronger magnetic materials enable us to reach a higher transferable torque for the same geometry of the drive and rotor. ZETA offers a wide range of drive sizes with operating torques from 30 Ncm to 300 Nm to suit every specific application. BMRT magnetic impellers ensure that the optimal formulation of the product is achieved throughout the whole volume. When the product is being transferred out of the vessel, the homogeneity of the mixed product is maintained reliably down to the last drop. The open design enables easy cleaning (CIP) and sterilisation (SIP). For more information, please contact: ZETA Biopharma Zetaplatz 1, 8501 Lieboch/Graz Austria Tel: + 43 3136 90 100 E-mail: info@zeta.com

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High Purity Water Storage and Distribution In order to meet the PW and WFI quality objectives, the US FDA recommends generation of PW and WFI where and when required. However, with growing demand, bigger plant sizes and layouts for pharma and biotech industries, it is increasingly becoming difficult to generate PW and WFI where and when required. Hydropure high purity water storage and distribution systems are designed to store and distribute PW and WFI water to various user points maintaining the generated water quality.

For more information, please contact: Hydropure Systems Pvt Ltd 412 Diamond Estate Off W E Highway Dahisar (E), Mumbai 400 068 Tel: 022-28978725, 28979097 E-mail: info@hydropure.in

Paddle Mixer Blender The paddle mixer blender is used for uniformly, effectively optimum dry and wet mixing and blending application in the food, chemical, pharma, detergent and pesticide industries. It is available in 10 to 10,000 litre capacity. Inner and outer paddles have special mixing effect with axial and fluidization movement of materials to homogeneous mixing independent of large range of particle size, shape or density. It is able to mix in approx 60 seconds for dry application. Minimum heat generated and high particle movements. Fast, even liquid and ingredients addition and coating with spray system.

For more information, please contact: Prism Pharma Machinery Plot No: 3713, Phase IV, GIDC Vatva, Ahmedabad, Gujarat 382 445 Tel: 079-29095204, Fax: 91-079-25841623 E-mail: mkt@prismpharmamachinery.com sales@prismpharmamachinery.com

High-speed Doors Prime Plus external door engineered for any industrial application. It is fast, reliable and energy efficient during strong drafts. It has galvanised steel structure as standard, SS matt finish structure which integrates traction unit, rapid wirings and safety photocells. Spring steel wind locks in curtain pocket, with side twin rollers, ensures silent door travel, higher wind loads and curtain stability. Integrated motorisation for heavy duty user 400 V three-phase, opening speed up to 2.0 m/s with inverter system. IP 65 electronic panel complete with open-close-emergency stop pushbutton unit and self-test function. It is resistant to wind load according to EN 12424 Class 3 / 4. Size is up to 10,000 mm x 7,000 mm (W x H).

For more information, please contact: Gandhi Automations Pvt Ltd Chawda Comml Centre Link Road, Malad (W) Mumbai 400 064 Tel: 022-66720200, 66720300 Fax: 91-022-66720201 E-mail: sales@geapl.co.in

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Reactor Solution S2 offers a range of SS nickel and exotic alloy reactors in a variety of materials such as SS-316L, SS316, Ti, SS-904L, Duplex, Titanium and Alloy C22. S2 also offer high chemical resistant reactors with product wetted parts coated in enamel or StanCoat for improved protection. Probably the highest risk in any reactor process is taking a process media sample at elevated temperatures. Spill over and exposure of sampling liquid is a perennial cause of batch rejection, reprocessing and various quality-related issues ultimately leading to personnel risk and lost profit. Their sampling systems are designed to provide automatic vacuum-operated safe sampling whereby a pre-established sample quantity is directly pulled into the sampling container in a closed-loop manner. At all times, the operator is in full control, safe and isolated from the product media. Their design is optical sensor powered and is offered with a clear sampling pot so that the operator can see exactly what is happening to the reacted substances at all stages of the reaction process. Furthermore, distributed control system operation is possible and unlike conventional systems, cleaning is easy, fast and risk-free. For more information, please contact: S2 Engg Services Survey No: 53/4, Bahadurpally Village Qutabullapur Mandal, R R District Hyderabad, Telangana 500 043 E-mail: info@s2engineeringindia.com

RCVD Solutions S2 Engg provides full turnkey solutions for rotary cone vacuum dryers (RCVDs) from design and manufacture to assembly, installation and commissioning. Their solutions provide equipment versatility and space saving benefits which reduce a plants capital and operating costs. The S2 Engg RCVD is completely jacketed for optimum dryer efficiency. Heat transfer fluid, typically hot water, steam or vapour, is circulated around the conical jacket for even product drying through conduction. S2 can supply the thermal control unit for this purpose, where required. As the dryer rotates, given the shape of the vessel, the entire product batch is thoroughly mixed and high speed dried. This blending and inter-folding process maintains uniform temperatures and eliminates any probability of product recondensation due to cold spots. S2 then use a high vacuum to draw off any remaining moisture while the product is in motion and thereafter the batch is easily discharged and cleaned given the conical shape of the vessel. . RCVDs provide a range of operational benefits making them an ideal dryer for batch production in small laboratories or research and development plants. For more information, please contact: S2 Engg Services Survey No: 53/4, Bahadurpally Village Qutabullapur Mandal, R R District Hyderabad, Telangana 500 043 E-mail: info@s2engineeringindia.com

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Tablet Press Machine IPEC Engg offers tablet press machine the most efficient way for single and double rotary tableting. Double layer and pre-compression is also available. This rotary tablet press machine is built as per the cGMP directives with total robust construction. This machine is useful for small to medium batch size production. Feature modern PLC operating system. Tablet press machine is available in 8 to 72 station range. 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

Facility Monitoring System Their facility monitoring software has been in use in pharma installations and has been updated to meet the rigorous demands of 21 CFR Part 11 with regard to electronic records. The software runs under MS Windows based around a real time database of results gathered from the datascan and particle counter instruments. Each module has been subject to a full qualification procedure offering unrivalled reliability. For more information, please contact:

Shreedhar Instruments 16 Shreeji Krupa Society, Opp: MGVCL Circle Office Next to GMERS Medical College Gotri Road, Vadodara Gujarat 390 023 E-mail: sales@shreedhargroup.com

Indoor Air Purifier Camfil offers its advanced indoor air purifier, CityM. Designed and engineered in Sweden, Camfil CityM Air Purifier is equipped with the most sophisticated particulate and molecular filters. Termed as a standalone air-cleaner, the key to its performance is installation of two in one filter on both sides to remove gases and ultrafine particles; each filter individually certified to be at least 99.97% effective on particulate matter of less than 0.3 microns in size. Catering to an average air purification area of 800 sq ft or 75 m 2 , CityM consumes lower energy with six operating speed options. It is certified allergy-friendly by the ECARF (European Centre for Allergy Research Foundation), and approved by the AHAM (Assn of Home Appliance Mnfrs USA) because of its efficiency in removing tobacco smoke, dust and pollen. Many of the harmful particles are common indoor air pollutants like formaldehyde, fungi and various VOCâ&#x20AC;&#x2122;s (Volatile Organic Compounds), leading to hazardous health diseases, including Asthma. The HEPA filter used in CityM is that air would have to pass through an average ventilation system thrice, to achieve the same level of purification. For more information, please contact: Camfil Air Filtration India Pvt Ltd 62, IDC, Mehrauli Road Gurgaon, Haryana 122 001 Tel: 0124-4874101 Fax: 91-0124-4082405 E-mail: pksv.sagar@camfil.com

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High-speed Door Prime Machine’s internal door engineered for any industrial application, safety for personnel while robotic operation is in progress. It has a reduced cycle time with fast open and close operation. Galvanised steel structure as standard, SS matt finish structure, which integrates traction unit, rapid wirings and safety photocells. Friction resistant semi-hard PVC door bottom laced with safety sensors. It has a spring steel wind lock in curtain pocket to ensure silent door travel and curtain stability. Integrated motorization for heavy duty use 400 V three phase opening speed up to 2.0 m/s with inverter system. IP 65 electronic panel complete with open-close-emergency stop pushbutton unit and self-test function. Size is up to 4,000 x 4,000 mm (W x H).

For more information, please contact: Gandhi Automations Pvt Ltd Chawda Comml Centre Link Road, Malad (W) Mumbai 400 064 Tel: 022-66720200, 66720300 Fax: 91-022-66720201 E-mail: sales@geapl.co.in

Conductivity Reference Solutions ROMIL offers PrimAg conductivity reference solutions for the calibration of conductivity meters, further extending the comprehensive PrimAg range of certified reference materials (CRMs). Each calibrant or reference solution is supplied with a certificate of calibration detailing its calibrated or measured conductivity, as well as the associated uncertainty traced to ROMIL primary silver. ROMIL is the only UK CRM manufacturer accredited to ISO 17025 requirements for calibration, and each PrimAg product is manufactured according to ISO Guide 34 and fully traceable to SI units, eliminating the need for any additional validation. The launch further extends this extensive product portfolio, perfectly complementing the existing broad selection of single and multi-element reference solutions, multi-ion solutions, pure stoichiometric substances and volumetric reagents, plus bespoke calibration mixes tailored to specific user requirements and instrumentation. For laboratories needing to meet the forthcoming USP <232>/<233> regulations for the determination of elemental impurities in pharma products and dietary supplements, PrimAg calibration mixes containing between six and 15 elements suitable for the calibration of inductively-coupled plasma methodologies are also available. Alternatively, laboratories can choose individually formulated reference solutions, custom-manufactured from high purity constituents characterised via the PrimAg traceability scheme to match specific analytes or required concentrations. For max flexibility, there is a choice of PrimAg-xtra, PrimAg-plus or PrimAg-lite – depending on the CRM – offering a range of certification levels to suit each laboratory’s specific applications. For more information, please contact: ROMIL Ltd The Source Convent Drive Waterbeach, Cambridge CB25 9QT, U.K. Tel: +44 (0) 1223 863876

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Fluid Bed Processor/Dryer The system is based on air suspension technology with GMP compliance. The SEBP is designed for drying, granulation or cooling of powders/granules/pallets (capable of being fluidized) by means of top spray or bottom spray. Material is loaded in the product chamber and fluids are sprayed through air atomizing spray gun while fluidizing the material in the expansion chamber. A peristaltic pump is employed for precise delivery of coating fluids. The coated material is dried with dehumidified, heated and filtered air supplied from an inlet AHU having 10 micron and 5 micron pre-filters, de-humidification and heading system followed by 0.3 micron HEPA filters.

For more information, please contact:

Sunsai Pharma Equipments Pvt Ltd Plot No: 1, Survey No: 77, Nr Laxmi Indl Estate Sativali Road, Vasai (E) Maharashtra 401 208 Tel: 0250-3200130 E-mail: sunsai.pharma@rediffmail.com / sunsaipharma@gmail.com

Continuous/Online Air Particle Counter The Met One 6000 Series remote airborne particle counter offers accurate and reliable continuous particle monitoring. With an array of communication and mechanical installation options, the Met One 6000 is easy to integrate with any facility monitoring system. These features also reduce downtime for instrument removal and reinstallation during routine calibration and preventative maintenance cycles. Built with long life laser technology, the Met One 6000 offers industry leading diagnostic features that reduce troubleshooting time and related downtime costs.

For more information, please contact: Shreedhar Instruments 16 Shreeji Krupa Society Opp: MGVCL Circle Office Next to GMERS Medical College Gotri Road, Vadodara, Gujarat 390 023 E-mail: sales@shreedhargroup.com

At-line Elemental Analysis Malvern Panalytical offers Epsilon 4, the new high-performance benchtop analytical tool for the determination of the chemical composition of all kinds of material. Built on the experience and success of the proven Epsilon 3 range of XRF spectrometers, the Epsilon 4 is a multi-functional instrument opening new applications for industries such as mining, pharma or oils and fuels who are obliged to comply with international regulations and test methods. Combining the latest advances in excitation and detection technology with mature software and a smart design, the analytical performance of the new benchtop instrument approaches the one of more powerful and floor-standing spectrometers. Its high performance enables most applications to be operated at ambient conditions, reducing costs for helium or vacuum maintenance. The unique low-drift metal-ceramic X-ray tube, designed and manufactured by Malvern Panalytical, delivers compliant results for years without the need for costly re-calibration. The instrument can automatically process sample batches without the need for operator attention. Epsilon 4 is a highly flexible tool available in a 10-Watt version for elemental analysis (F â&#x20AC;&#x201C; Am) in areas from R&D through to process control. For even higher sample throughput or extended light-element capabilities and in more challenging environments a 15-Watt version is available, which can even analyze carbon, nitrogen and oxygen. For more information, please contact:

Malvern Panalytical (A Division Spectris Technologies Pvt Ltd) 4 th Floor, 351 ICON Western Express Highway, Andheri (E) Mumbai 400 069 Tel: 022-26820804, 26820806

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Capsule Filling All capsules filling in Sejong Pharmatech are operated and controlled via a 15 inch large touch screen mounted on the operation panel. It has newly additional sampling checker and AWC function makes it easier to control and manage the equipment. Also, it is designed to ensure all data on product manufacturing stored, saved and printed. With an alarm function, one can promptly handle any malfunction or problem. Newly designed sampling machine is the device where capsule weight is checked on a regular basis for requested time and capsule quantity. It can be easily controlled from main touch screen, capsule’s weight, individual deviation, average points are all displayed in the touch screen at a real time base. Also, all the data and parameter can be printed from the optional printer. Furthermore, by adopting more compact size in exterior, it enables easy movement and usage of space. Defective capsule in the capsule of the cap and the body should not be separated for poor discharge pin. Through the pin up and down motion and air block can eject faulty capsules (not separated by cap and body) more enhanced. By deleting up and down motor which is required to be dismantled, and with the use of simple structure, it can independently dismantle and assemble powder hopper, maintaining easy cleaning and stable maintenance. For more information, please contact: Allpharma Technologies Pvt Ltd A-404 Rajeshri Accord Teli Galli Cross Lane Andheri (E), Mumbai 400 069 E-mail: ravi.sharma@allpharma.in

Heat Sealable Thermoplastic Elastomer Tube Imaweld is thermoplastic elastomer opaque tubing designed for fluid transfer in pharma and biotech applications. Imaweld is specially formulated which meets requirement of pharma industries with superiority compared to PVC and silicone. Imaweld complies with FDA 21 CFR 177.2600, USP Class VI and ISO 10993. It is manufactured and packaged under GMP guidelines in dust-free area of ISO 9001 QMS, ISO 14001 and OHSAS 18001 Certified facility. It is heat sealable and weldable. It can be laser etched for traceability. It has excellent flexibility and flex crack resistance. It also has excellent acid and alkali resistance. It’s smooth bore surface eliminate particle entrapment. It has superior chemical resistance compared to silicone. It is sterilizable by Steam, Gamma Radiation and Ethylene Oxide. It has custom dimension and length size available. It is also available in transparent colour. For more information, please contact: Ami Polymer Pvt Ltd 319 Mahesh Indl Estate, Opp: Silver Park Mira-Bhayander Road, Mira Road (E) Thane, Maharashtra 401 104 Tel: 022-28555107, 28555631, 28555914 E-mail: mktg@amipolymer.com

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Slim Line Ball Valves Cipriani Harrison’s slim line ball valves are made from forged SS304L and SS-316L, are highly polished and come standard with TFM-PTFE seats and FDA EPDM O-rings. The 2 piece design provides a compact and economical solution while maintaining a full port design, as well as being fully drainable. Available in size 1-4” with sanitary clamp, Butt-weld or I-line end connections. They are available with or without purge ports and either manually or pneumatically controlled.

For more information, please contact:

Cipriani Harrison Valves Pvt Ltd Sub Plot No: 2, B/s Margin Impex Ltd Nr Phase IV, GIDC Estate V U Nager, Anand, Gujarat 388 121 Tel: 02692-235082, 234182, Fax: 91-02692-236385 E-mail: info@harrisonengineers.com

Check Valves Cipriani Harrison’s check valves are made from forged SS-304L and SS-316L, are highly polished and come standard with PTFE O-rings and gaskets. These non-return valves are selfdraining in the vertical position. The newly designed ribbed stainless disc resists water hammer, minimizes the resistance to flow and serves as a guide to the valve plug. Available in sizes ½”-4” with sanitary clamp, Butt weld and I-line end connections as standard. Special springs are offered to allow for flexibility in design and use. Size 1” to 4” valves are 3A authorised. For more information, please contact:

COD Analysis System As a leading manufacturer in this field, Spectralab Instruments offer a broad range of environment products. COD analysis system is one of them.The chemical oxygen demand (COD) test is used to estimate the amount of organic matter in wastewater. Most types of organic matter are oxidized by a boiling mixture of chromic and sulphuric acid. A sample is refluxed in strong acid solution with a known excess of potassium dichromate. After digestion, the remaining unreduced K 2 Cr 2 O 7 is titrated with FAS to determine the amount of K 2 Cr 2 O 7 consumed and the oxidizable organic matter is calculated in terms of oxygen equivalent.The Spectralab COD test system is open reflux method. It is suitable for wide range of wastewater - a large sample size is preferred. This system is followed by the American Standard Test (APHA) method. There is no need to circulate water; precise digestion with digital timer and buzzer; results on display by using COD Titrator Model CT-15 are some of its features. .

COD digestor is being used by almost all regulating, environmental institutes and industries. Solid block heated units with provision for 6 and 15 samples at a time using air condensers with uniformity of temperature. COD titrator is a microprocessorbased design that speeds up the titration process giving advantage like automation, accuracy, result in storage, printout, etc.

For more information, please contact:

Spectralab Instruments Pvt Ltd W-446, Rabale MIDC Rabale, Navi Mumbai 400 701 Tel: 022-62556868, 65015757 E-mail: marketing@spectralab.biz / sales@spectralab.biz

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AHU Pre-filter Cleaning & Drying Machine Ultramax Hydrojet Pvt Ltd offers automatic washing and complete drying of AHU pre-filters in SS as per cGMP norms. It can accommodate filter size from 150 x 150 x 50 to 610 x 610 x 355 mm. Customised machine manufactured according to customized requirement. Filter range is from 3 to 20 u. It finds application in formulation, vaccine, bulk drug and intermediates, hospitals and electronic and space application.

For more information, please contact: Ultramax Hydrojet Pvt Ltd AC-31/4A, 6th Main Road, SIDCO Indl Estate Thirumudivakkam, Chennai 600 044 Telefax: 91-044-42852262, 42852264 E-mail: marketing@hydrojet.co.in

Heat Exchangers Kipp Umwelttechnik offers fast and gentle cleaning for all types of fin heat exchanger with its JetMaster+ system. Made up of four combination devices, the JetMaster+ system is also successful where other cleaning systems cannot help. Kipp Umwelttechnik is now 100 per cent effective in cleaning spiral-finned tubes in tight spaces, even with extremely hard deposits. Stones have even been removed from the equipment. Many other companies had already tried and failed. Kipp Umwelttechnik has been successful in cleaning tube bundle heat exchangers for many years. The TubeMaster process from its sister company mycon GmbH cleans tubes without residue and removes even the toughest deposits. The interior of the tubes can even be polished at the same time – significantly reducing energy costs and increasing production capacity. Cleaning removable plate heat exchangers using the PowerMaster system has also long been part of Kipp Umwelttechnik’s work. Supported by a regional university in 2017 Kipp Umwelttechnik developed its own flushing technique for cleaning closed plate/tube bundle heat exchangers. Kipp Umwelttechnik based the new system primarily on green chemistry that cleans gently, can be reused and after multiple uses, can later be recycled or neutralised. For the biogas plant sector, there is a fully-equipped vehicle that carries the necessary cleaning equipment at all times. In collaboration with the system’s manufacturer, sister company mycon GmbH, Kipp Umwelttechnik also offers the JetMaster system for cleaning all types of fin heat exchanger for hire, together with the compressor required if necessary. All heat exchangers can also be cleaned at their premises for a fixed price. If required, we can collect the equipment from your site and return it after.

For more information, please contact:

Kipp Umwelttechnik GmbH Lorenzstraße 29, 76135 Karlsruhe, Germany Tel: +49 (0) 721 98 77 93 17, Fax: +49 (0) 721 98 77 93 11 E-mail: m.kueppershaus@kipp-umwelttechnik.de / service@pressebox.de

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International Exhibition & Conference February 2018 : Mumbai, India

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events diary      

  

Date: 7 th – 9 th March 2018 Venue: ITC Grand Central, Mumbai

Date: 25 th – 28 th March 2018 Venue: Philadelphia Marriott Downtown, USA

CPhI’s 7 th Annual Pharma IPR Conference happening on 7-9 March 2018, Mumbai is a leading platform for Indian pharmaceutical companies to interact with the IP Attorneys and Counsels from across the globe and discuss the recent trends and best practices in the pharma IPR space. Since 2012, Pharma IPR Conference has focused on importance of Intellectual Property in Pharma syncing it with business objectives of Indian Pharma companies.

As the world’s leading life sciences meeting management conference, Pharma Forum is the place where corporate and third-party planners convene with supplier partners to build relationships and take part in an unmatched learning experience. This 14 th installment features innovative meeting design concepts, encourages meaningful face-to-face networking, offers solutions to industry-wide compliance challenges and provides more educational breakout sessions than ever before.

This three-day conference will provide ample opportunities for business networking with visionary entrepreneurs and industry experts around the world.  Dhruv Khanna Senior Manager - Conferences Ph: +91 9930307433 Email: dhruv.khanna@ubm.com

 Jamie McHugh Ph: +1-339-298-2106 Email: jamie.mchugh@cbinet.com

 

     it

Date: 19 th – 21st March 2018 Venue: Berlin, Germany

Date: 17 th – 18 th May 2018 Venue: Shanghai, China

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.

The 2018 China International Pharma 4.0 Summit will bring together over 300 delegates from relevant governments, associations, institutions, pharmaceutical manufacturers, pharmaceutical equipment suppliers, intelligent solution providers of pharmaceutical, packaging, warehouse and logistics, among those the industry regulators, experts and opinion leaders will share the latest policies and regulations, global market trends, technical innovation in the whole chain of drug production, architecture and practice of intelligent pharmaceutical plants as well as advanced technologies such as robotics, AI, informatization, IoT, big data, cloud computing, comparing notes on the transformation and upgrading of pharmaceutical industry.

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

56 ◄ February 2018

 Patrick Chow Ph: +86 21 6485 6566 – 614 Email: patrick.chow@borscon.com

Pharma Bio World

bookshelf Biosimilars: A New Generation of Biologics (Hardcover) Authors: Jean-Louis Prugnaud, Jean-Hugues Trouvin (Editors) Price: USD 60.67 No of pages: 90 pages Biologics have revolutionised the treatment of many severe conditions, delivering exceptional clinical results but also producing exceptionally high prices. As patents expire, copies and price competition are expected throughout the world. However, due to the intrinsic heterogeneity and molecular complexity of biologic medicinal products, their copies cannot simply be authorized under the “generic rule” valid for small chemical entities. In response, a dedicated regulation was issued in the European Union. It is based on the concept of “biological medicinal products similar to a biological reference product”, or “biosimilars”. This book analyses the context of biotechnological production and addresses the European legal framework for biosimilar market approval. It highlights post-market authorisation issues, such as Risk Management Plans and substitution of products, and outlines some other issues, such as cost management and international nomenclature. This book is primarily intended for hospital-based physicians and pharmacists. It will also be a valuable resource for all actors from all countries who want to better understand the emergence of these new medicinal products within the European context.

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics (Hardcover) Authors: Lisa Plitnick (Editor), Danuta Herzyk (Editors) Price: USD 81.92 No of pages: 432 pages Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. This book compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory documents. Each section discusses a different type of biologic, as well as early characterization strategies, principles of study design, preclinical pharmacokinetics and pharmacodynamics and preclinical assays. An edited book that is authored by leading experts in the field, this comprehensive reference provides critical insights to all researchers involved in early through late stage biologics.

Biosimilar Drug Product Development (Drugs and the Pharmaceutical Sciences) Authors: Laszlo Endrenyi, Dr. Paul Declerck, Shein-Chung Chow (Editors) Price: USD 110.74 No of pages: 487 pages When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues. Pharma Bio World

February 2018 ► 57

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                             