Microbioz India : April 2019 edition

Microbioz India Volume - 05- Issue No. - 4 April 2019

www.microbiozindia.com

Featured article

Increasing demand of Fluorosilicone By: Amipolymer Pvt LTD Mumbai India

Market Research

Emcure launches world’s first generic Eribulin for treatment of metastatic breast cancer

Development of Biologics The market requires short development times and high productivity

www.ugabiopharma.com

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35 Cover Story

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The cover story of the month titled “Development of biologics: The market requires short development times and high productivityUsing a high-speed workflow to generate a production cell line”By UGA Biopharma GmbH. The cover story featured Biologics this month which includes their new therapy option for numerous diseases: They are already used to treat cancer and autoimmune diseases such as rheumatoid arthritis as useful alternatives to standard therapies.

Featured article 29 Added to this, the current edition has a special featured article titled “Increasing demand of Fluorosilicone “By Anuj Singh-Polymer Technologist Amipolymer Pvt Ltd the article includes, Fluorosilicone rubber is called as modified version of silicone rubber which has been fluorinated to finish up the polymer chains so that its chemical resistance is improved.

Fluorosilicone is also known as FVMQ (fluorovinylmethylsiloxane).

Product Launches 43 The edition also covers recent Pharma news articles and product launches collected from worldwide sources to update the readers with the current trends in the industry

Emcure launches world’s first generic Eribulin for 20 treatment of metastatic breast cancer Eribulin will be available in India at approximately 40% cost of the innovator brand Emcure Pharmaceuticals, a leading integrated global pharmaceutical company from India today announced the launch of the world’s first generic version of Eisai Pharmaceutical’s Halaven (Eribulin) for the treatment of metastatic breast cancer (MBC).

Manual pipetting of 384-well plates made easy!

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Chennai, April 09, 2019 – Once throughput increases and sample volumes decrease, users face a dilemma. The so-called “alternate well pipetting method”, which uses 8 and 12 channel pipettes to fill 384-well plates, demands intense concentration; furthermore, it is time-consuming and carries a high risk of error.

Manufacturing problems persist for Aurobindo, U.S.' second-largest generics producer

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When Aurobindo forked over $1 billion to snap up some of Novartis’ unwanted drugs last year, it set the Indian drugmaker up to be the second-largest generics player in the U.S.

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ear friends and readers, I hope you would have enjoyed reading our previous issue. Once again, I am delighted to bring for you the April 2019 edition of Microbioz India magazine, supported by the cover story titled “Development of biologics: The market requires short development times and high productivity-Using a high-speed workflow to generate a production cell line”By UGA Biopharma GmbH.The cover story featured Biologics this month which includes their new therapy option for numerous diseases: They are already used to treat cancer and autoimmune diseases such as rheumatoid arthritis as useful alternatives to standard therapies.

Added to this, the current edition has a special featured article titled “Increasing demand of Fluorosilicone “By Anuj Singh-Polymer Technologist Amipolymer Pvt Ltd, the article includes Fluorosilicone rubber called as modified version of silicone rubber which has been fluorinated to finish up the polymer chains so that its chemical resistance is improved.

Fluorosilicone is also known as FVMQ (fluorovinylmethylsiloxane).

We have the latest market research news and insightful product launches inside, collected from worldwide sources to keep you updated with what is going on in the industry.

Dear friends and readers, I hope you find some value in the magazine. Also, I would like to thanks you for being together in this beautiful journey so far. We would love to have your valuable feedback and suggestions as they help us to come up with better content each time. For any further valuable addition, please write to us at editor@microbiozindia.com.

Cover Story

Development of biologics: The market requires short development times and high productivity Using a high-speed workflow to generate a production cell line Biologics offer new therapy options for numerous diseases: They are already used to treat cancer and autoimmune diseases such as rheumatoid arthritis as useful alternatives to standard therapies. The extent of their market potential is revealed by the fact that the number of patent applications has been on the rise for decades now. However, the route from the lab to mass production is much more complicated for biologics than for conventional drugs. The desired biomolecules (biologics) are manufactured using living systems, consequently a careful development and selection process of the cell line to be used, as well as thorough checks, are absolutely essential in order to ensure straightforward production later. For this reason, contract developer UGA Biopharma GmbH has developed a high-speed cell line development workflow including analytics, purification and bioprocess development in bioreactors. Using an optimised expression vector means that highly productive clones can be generated. In this way, monoclonal and highly productive cell lines can be developed within just four months, and an optimised bioprocess within a further three.

raditionally, drugs used in chemotherapy or antibiotics were produced using chemical synthesis.

By contrast, biologics are manufactured using genetically modified, living cells in bioreactors.

Many factors can significantly influence the quality of biologics manufactured in this way, including process conditions during manufacturing, such as temperature during fermentation, pH, dissolved oxygen concentration and nutrient supply and, of course, the cell line used. If the cell line is contaminated or the isolated monoclonal cell lines (clones) are unstable, the drug may end up being unusable – with correspondingly high financial losses for the manufacturer. For this reason, UGA Biopharma GmbH pays particularly close attention to the productivity, stability and quality of the clones when developing new cell lines. As a result of its specially optimised processes and many years of experience, the company only requires seven months for the development of a cell line,

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including bioprocess development and the development of a purification process, in addition to providing of all necessary analytical data.

From concept to production cell line UGA Biopharma’s work starts with a biomolecule: “If a biomolecule with a potential therapeutic effect is identified during the course of research at a university or a company, this may be an interesting discovery but it is still a long way from becoming a product. Often, research institutions and companies do not have the necessary expertise or capacities to quickly turn interesting discoveries into biotherapeutic products, or biologics,” explains Dr Lars Kober, Managing Director of UGA Biopharma GmbH. “This is where contract developers like us come in: We develop highly productive cell lines which are able to produce the desired biologics with high yields.”

To do this, the molecule first needs to be characterised in order to determine the desired quality attributes and the gene of interest (GOI), which will then be transferred into the company’s own expression vector. “In recent years, we have

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Cover Story optimised the expression vector and cell line generation work flow to such an extent that we are able to create highly productive stable production cell lines within a very short period of time, achieving product concentrations of up to 7 g/L,” Kober adds.

obtain useful information about the selection of promising clones early on in the process.

The isolated clones are then expanded in the next step: “Usually, therefore cells are cultivated at labscale in shake flasks. Many contract developers leave it at that.” However, in order to guarantee the scalability of the cell lines, the laboratory staff then carry out a process transfer into bioreactors and derive a suitable bioprocess from this.

In recent years, a Chinese hamster ovary (CHO) cell has proven particularly well suited. During cell line development, the expression vector is introduced into this CHO cell, creating a mixture of cells with different characteristics. Using singlecell cloning, highly productive monoclonal cell lines (clones) can then be isolated, cultivated and used to create cell banks for long-term storage at 196°C.

“But even the ‘best’ cell line is of no use to the pharmaceutical company if it cannot be cultivated and the manufactured biological drug cannot be purified,” Kober notes. As a result, UGA Biopharma does not restrict itself to the optimisation of the manufacturing process in bioreactors. Furthermore, the right purification process is also developed and the potency of the purified biologics is tested via various binding assays and in different cell culture models. If necessary, an optimised cell culture medium can also be provided for the cell lines and the developed manufacturing process.

Normally the company’s own culture medium, First CHOice, is used, which was developed by UGA Biopharma. With the aid of this medium and the relevant feeds, both the product concentration and thus the cost of goods achieved in the final manufacturing process, as well as the product quality of the manufactured biologics, can be influenced advantageously.

Searching for a suitable clone

Short development time is a prerequisite

“Generally speaking, pharmaceutical companies have many requirements of the isolated cell lines, such as scalability, monoclonality and, of course, high productivity and clone stability,” Kober explains. “In addition, the biologics should neither trigger immunogenic reactions in patients nor should the production cell lines be contaminated with viruses or mycoplasma.” For this reason, the company acts in accordance with the requirements of the European Medicines Agency (EMA), which is responsible for the evaluation and monitoring of drugs. During the development process, the company also conducts glycan analyses in order to

In total, it only takes seven months until the developed cell line can be supplied: four months are required for the cell line development and three for the bioprocess development, the development of the purification process and for analyses to be carried out. “Short development times are essential in the pharmaceutical industry because patent protection for pharmaceuticals generally expires after 20 years,” Kober emphasises. “In this time, all phases of the technological development, various clinical trials including the marketing authorisation procedure has to be completed as quickly as possible because

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Cover Story only includes a stable monoclonal cell line but also the First CHOice cell culture medium and the manufacturing and purification process,” Kober confirms. “It is our aim for all biologics to be

the profit margins for the drugs developed generally drop sharply once the patent protection has expired. Every month counts here because short development times facilitate early market entry and thus the profit is secured before the patent expires.”

manufactured to the same level of quality at their designated destination as they are in our laboratory.

This not only includes a stable monoclonal cell line but also the First CHOice cell culture medium and the manufacturing and purification process,” explains Dr Lars Kober, Managing Director of UGA Biopharma GmbH.

Dr. Lars Kober

Once development is complete, the company supports its customers where necessary with the process transfer to the manufacturing facility and is always on hand if there are any problems. “It is our aim for all biologics to be manufactured to the same level of quality at their designated destination as they are in our laboratory. This not

UGA Biopharma GmbH was founded in Henningsdorf near Berlin in 2009. The company’s core area of business is the contract development of biologics and biosimilars. This involves all the necessary steps from cell line development and bioprocess development to the development of purification processes and analytics. Furthermore, high-performance cell culture media and feeds are supplied under the trade name First CHOice in order to optimise the quality and product concentration of biologics and biosimilars. If necessary, the company can support its customers in transferring the manufacturing process to their production facility. UGA Biopharma’s unique selling feature is also that it offers its customers what are known as ready-to-use biosimilar cell lines. The company supplies its customers in Germany and abroad from its headquarters in Henningsdorf and already has several users with UGA products in clinical trials or who have already received a market approval.

For more informtion: UGA Biopharma GmbH Neuendorfstraße 20 (Gebäude 20 A), 16761 Henningsdorf, Germany Phone: +49 (0)3302 202490-0, Fax: +49 (0)3302 202490-1 Email: info@ugabiopharma.com Website: www.ugabiopharma.com

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Business News

Emcure launches world’s first generic Eribulin for treatment of metastatic breast cancer Eribulin will be available in India at approximately 40% cost of the innovator brand Emcure Pharmaceuticals, a leading integrated global pharmaceutical company from India today announced the launch of the world’s first generic version of Eisai Pharmaceutical’s Halaven (Eribulin) for the treatment of metastatic breast cancer (MBC). Emcure will be marketing the drug under brand name ‘Eribilin’, with an aim to offer

high-quality and cost-effective treatment option to breast cancer patients in India.

As per reports from the Indian Council of Medical Research & Population Based Cancer Registry (ICMR-PBCR) Breast cancer is the commonest occurring cancer in urban Indian women and the second commonest in rural women. Although world class breast cancer treatment is available in India, majority of the patients are unable to access it due to lack of quality infrastructure, skills and above all financial resources.

“Incidence of breast cancer is on the rise in India and being a price sensitive market with low awareness, with the launch of Eribilin we aim to provide a proven and cost-effective treatment of

high quality and efficacy as offered by the innovator brand. It is a proud moment for Emcure to launch Eribilin, the world’s first generic version of the innovator brand that will break the price barrier making it a cost-effective option for patients,” said Mr. Sainath Iyer, President – Business Strategy & Specialty Business – Emcure Pharmaceuticals Ltd Various Indian studies suggest that about 20% of breast cancers are triplenegative breast cancers.

Triplenegative breast cancer (TNBC) is cancer that tests negative for estrogen receptors, progestero ne receptors, and excess HER2 protein. It means that the growth of the cancer is not fuelled by the hormones estrogen and progesterone, or by the HER2 protein. Even though chemotherapy may work well for this type of breast cancer, the chance of relapse is high and overall prognosis is poor than the other types of breast cancer.

Emcure’s Eribilin has been approved by DCGI to be marketed in India. “Breast cancer is the most common type of cancer affecting women in India and its incidence is on the rise. Currently available treatment for triple negative breast cancer in India is out of reach of most patients due to its high cost. Emcure’s Eribilin will change this scenario by offering a world-class, high quality drug at a

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Business News reasonable price to the patients in India” said Mr. Sainath Iyer, President – Business Strategy & Specialty Business – Emcure Pharmaceuticals Ltd Eribulin is a non-taxane inhibitor of microtubule dynamics and remains effective in MBC previously treated with an anthracycline and a taxane.

Eribulin is a complex API derived from a marine natural product called Halocondrin B. “Emcure’s R&D resources are equipped with technical competence and state-of-the-art development facility to develop such complex generics. Generic Eribulin is a landmark achievement of Emcure’s R&D efforts both in API manufacturing and formulation,” said Dr. Mukund Gurjar, Chief Scientific Officer, Emcure Pharmaceuticals.

Emcure will manufacture generic Eribulin at its state of the art plant at Hinjewadi in Pune and market it at a cost which will be approximately 40% less than the innovator brand bringing hope to millions of breast cancer patients in India. The drug would currently be marketed in India, About Emcure Pharmaceuticals Ltd.: Emcure Pharmaceuticals Ltd. is a leading vertically integrated global pharmaceutical company from India focusing on R&D, marketing and manufacturing of acute and chronic therapy range of products. It is ranked among the top 10 pharmaceutical companies in India and is the

however Emcure plans to register the brand in international markets as well, wherever the drug is about to go off-patent.

About Eribilin: Eribilin is world’s first generic version of Eisai Pharmaceutical’s Halaven (Eribulin) for the treatment of metastatic breast cancer (MBC).

Eribulin is a mechanistically unique inhibitor of microtubule dynamics and binds predominantly to a small number of high affinity sites through both cytotoxic and non-cytotoxic mechanisms. It eliminates cancer cells through prolonged and irreversible mitotic blockade. The parent molecule is a potent, naturally occurring mitotic inhibitor found in the sponge genus Halichondria.

ERIBILIN has been developed indigenously by Emcure Pharmaceuticals and offers the same quality and efficacy as the original brand.

ERIBILIN will be manufactured in Emcure’s plant at Hinjewadi, Pune. leading provider of oncology, nephrology, antiretroviral, gynaecology, cardiac, anti-malarial and anti-infective therapies. Globally it is present in 70 countries with 15 subsidiaries and 7 representative offices. Its range of products for the treatment of breast cancer includes Taxotere (docetaxel), Palcitaxel, Fulvestrant, Letrozole and Lapatinib.

Lupin appoints Ms. Christine Mundkur as an Independent Director Mumbai, April 1, 2019: Pharma major Lupin Limited (Lupin) announced today the appointment of Ms. Christine Mundkur as an Independent Director with immediate effect.

Ms. Mundkur most recently served as Chief Executive Officer and Non-voting Chairman of the Board of Directors for Impopharma Inc, a developer of complex formulations focused on inhalation pharmaceutical products. While at Impopharma, she led the transition of the company from a successful clinical research organization into a generic pharmaceutical inhalation development company.

She also held leadership positions as President and Chief Executive Officer for North America for Sandoz, Inc. Earlier, she served as Chief Executive Officer of Barr Laboratories, Inc. Ms.

Mundkur started her career at Barr as quality and regulatory counsel.

In addition, she served as a strategic advisor to clients on generics, 505(b)2, biosimilars and NDA business strategies. She currently serves on the

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Business News Board of Directors for ManKind Corporation in the U.S. Ms. Mundkur holds a J.D. from the St. Louis University School of Law and also received a B.S. degree in chemistry from St. Louis University.

Commenting on the appointment, Vinita Gupta, Chief Executive Officer, Lupin said, “We are delighted to welcome Ms. Mundkur to our Board.

Her extensive experience in the global pharma industry, significant knowledge in areas like inhalation, biosimilars and proprietary women’s

health, and strong experience in operations and quality will be a great asset for Lupin.”

About Lupin Limited Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.

Lupin Bioresearch Centre completes fifth successful U.S. FDA inspection Mumbai, Baltimore, April 03, 2019: Pharma major Lupin Limited (Lupin) announced the successful completion of the United States Food and Drug Administration (U.S. FDA) inspection at its Lupin Bioresearch Centre (LBC) without any observations.

This is the fifth successive inspection without any

483 observations, indicating superior quality

compliance maintained at this global bioresearch facility.

Lupin Bioresearch Centre (LBC) conducts the invivo and in-vitro bioequivalence studies for Lupin in Pune. This inspection also included review of studies done at the center’s new site at Lupin Research Park, Pune.

Commenting on the successful inspection, Mr. Nilesh Gupta, Managing Director, Lupin expressed satisfaction about the quality management system maintained in LBC and said “Such a high level of compliance reiterates Lupin’s commitment to high-quality standards across its world class research centres.”

Featured Article

Increasing demand of Fluorosilicone Introduction: Fluorosilicone rubber is called as modified version of silicone rubber which has been fluorinated to finish up the polymer chains so that its chemical resistance is improved. fluorosilicone is also known as FVMQ (fluorovinylmethylsiloxane).

It can be processed by compression molding, calendaring, extrusion, and liquid injection molding. Fluorosilicone rubber displays a working range between -60°C and +225°C. Fluorosilicone rubber is formulated from fluorosilicone polymers that contain a (-Si-O-) repeating group on the polymer backbone. One

unique difference, compared to their dimethylsiloxane counterparts, is the incorporation of a fluorine component attached to the polymer backbone. Fluorosilicone polymers replace one (methyl) side group on each silicon with a (trifluoropropyl) side group.

Structure: - fluorosilicone rubber contains trifluoropropyl groups that enhance its chemical resistance to non-polar solvents, fuels, oils, acids, and alkaline chemicals and also a flame retradance. The unique properties of fluorosilicone make it a problem-solving material

Figure1: Properties of FVMQ (4: Excellent, 3: Good, 2: Average, 1: Bad) Microbioz India, April 2019

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Featured Article Why FSR (Fluoro silicone rubber) are in demand? It will be easy to understand with the difference.

FSR Difference with others OTHER SILICONE RUBBER (MQ/VMQ/PVMQ)

FVMQ (Fluorovinylmethylsiloxane)

Ordinary resistance to fluids.

Superior Resistance to many fluids.

It has lesser low temperature flexibility.

It has better low temperature flexibility.

Can’t be operate temperature.

a

wide

range

of Can be operate a wide range of temperature.

FSR can be blended with other silicones to obtain a fluid resistance that is intermediate between the two polymer types. Since FSR has a significantly higher cost than other silicones.

FKM (Viton) Poor Flow Characteristics due to high viscosity.

In High temperature application up to 200°C the tear strength and elongation is low as compared to FSR.

Due to the extremely polar fluorine element in the chemical structure of FSR, FSR shows superior resistance to many fluids.

FVMQ (Fluorovinylmethylsiloxane) Good Flow characteristics due to optimum viscosity.

In High temperature application up to 200°C the tear strength and elongation is high as compared to FSR. While the tensile strength of FKM & FSR are comparable.

Area of Demand (Applications) The increasing use of Fluorosilicone rubber in the pharmaceutical industry for fluid transfer, peristaltic pumping and filling operations. Fluoro Silicones are UV stable, thermally and chemically stable. Its Resistance to bacteria ease of sterilization, and non-reactive with the body and other materials means that silicone is the material of choice for medical applications and infant care products. That widely used in industrial, aerospace, automotive and aviation applications for static sealing and cushioning.

It is also used in

• Fuel line quick-connect seals • Electrical connector inserts • Air pump valves • Exhaust gas recirculating diaphragms • Turbocharger hose liners • Fuel-resistant hydraulic and electrical clamp blocks • Vapor recovery management system seals • Natural vacuum leak detection control diaphragms • Engine gaskets • Fuel line pulsated seals • Brake vacuum units.

By. Anuj Singh (Polymer Technologist) Ami Polymer Pvt. Ltd. Email ID: research@amipolymer.com

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Product Coverage

Manual pipetting of 384-well plates made easy!

Chennai, April 09, 2019 – Once throughput increases and sample volumes decrease, users face a dilemma. The so-called “alternate well pipetting method”, which uses 8 and 12 channel pipettes to fill 384-well plates, demands intense concentration; furthermore, it is time-consuming and carries a high risk of error.

With their 16 and 24 channels, the new mechanical multichannel pipettes Eppendorf Research plus and the new electronic multichannel pipettes Eppendorf Xplorer plus can now tackle entire columns and rows of a 384-well plate in one single step. Up to 24 reactions may thus be started and stopped simultaneously. An entire plate can be managed manually within the space of a minute.

In this way, the user will save time while at the same time improving the reproducibility of their results.

The system that comprises the innovative Eppendorf pipette tips epT.I.P.S.® 384 and ep Dualfilter T.I.P.S.® 384 will afford the user the utmost security. The unique SOFTattach technology utilizes elastic forming grooves that contribute to a perfect tip fit as well as to a perfect seal of the system. The tip attachment forces could thus be reduced by an additional 40% per cone. An extremely fine tip shape that displays perfect coaxiality makes secure maneuvering of samples into the tiny wells of a 384-well plate as easy as pie. With these innovations, the Eppendorf PhysioCare Concept® has once again achieved a significant leap forward, and even under conditions of increased throughput, the pipetting experience has now become even more ergonomic and comfortable.

The new products will be introduced for the first time at the Labvolution exhibition in Hannover in May 2019. Additional information, including a

contact form to request a demo, is available at www.eppendorf.com/ready-set-pipette.

About Eppendorf: Eppendorf is a leading life science company that develops and sells instruments, consumables, and services for liquid handling, sample handling, and cell handling in laboratories worldwide. Its product range includes pipettes and automated pipetting systems, dispensers, centrifuges, mixers, spectrometers, and DNA amplification equipment as well as ultra-low temperature freezers, fermentors, bioreactors, CO2 incubators, shakers, and cell manipulation systems. Consumables such as pipette tips, test tubes, microtiter plates, and single-use bioreactor vessels complement the range of highest-quality premium products.

Eppendorf products are most broadly used in academic and commercial research laboratories, e.g., in companies from the pharmaceutical and biotechnological as well as the chemical and food industries. They are also aimed at clinical and environmental analysis laboratories, forensics, and at industrial laboratories performing process analysis, production, and quality assurance.

Eppendorf was founded in Hamburg, Germany in 1945 and has more than 3,100 employees worldwide. The company has subsidiaries in 26 countries and is represented in all other markets by distributors.

Press Contact: M. Anthoni Jai Kumar, Eppendorf India Limited Tel: +91 44 663 12 222 anthoni.jk@eppendorf.co.in www.eppendorf.co.in Chennai

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Event Coverage

The analytical and laboratory industry gears up for analytica Anacon India and India Lab Expo in Mumbai 1. Strong domestic and international participation 2. 4000+ key visitors accompanied by buyer seller meetings 3. Knowledge rich conferences powered by key industry associations Mumbai: The upcoming 13th edition of analytica Anacon India and India Lab Expo, India’s leading exhibition on laboratory and analytical technologies, will be held over 2 days from 16 to 17 April at Bombay Exhibition Centre, Mumbai.

The exhibition is spread over 4000 sqms and will feature 100+ global and Indian companies with 4000+ visitors expected in 2 days accompanied with power-packed conferences and buyer- seller meetings at the designated forum.

The exhibition will bring together the best of the technologies pertaining to chromatographs, spectroscopes, microscopes and imaging, bioinformatics, medicine & diagnostics, life

sciences, analytical instrumentation systems and laboratory furniture from across the globe.

Strong Indian and international participation Along with an impressive participation from the Indian companies, the trade fair also gathers strong participation from international brands including JAIMA (Japan), International Accreditation Service (USA), Techcomp (Hong Kong), Contec Medical Systems (China), VICI AG International (Germany), Agilent Technologies, Peak Scientific Instruments and Beckman Coulter representing other participating countries.

Bhupinder Singh, Chief Executive Officer of Messe Muenchen India highlights: "We are all set to put up an interesting business platform through this exhibition. The variety of domestic and international laboratory and analytical solution

providers will be a good sourcing platform for the industry stakeholders. We welcome all our participants and wish them good luck for the exhibition."

4000+ key visitors accompanied by buyer seller meetings: The Mumbai edition is expected to attract 4000+ trade visitors from pharmaceuticals, chemicals, food processing, and biotechnology, healthcare, diagnostics and R&D industry. Some of the top visiting companies include Cipla, Sun Pharma, Glenmark, IPCA, Lupin Pharma, Institute of Chemical Technology, Ajanta Pharma and Johnson & Johnson. More than 300 one-to-one meetings are expected to be scheduled in the buyer-seller forum in a span of two days.

Knowledge rich conferences powered by key industry associations Along with the Indian Analytical Instruments Association (IAIA), industry trade bodies like Japan Analytical Instruments Manufacturers’ Association (JAIMA), National Accreditation Board of Laboratories (NABL), Indian Drug Manufacturers’ Association (IDMA), Indian Chemical Council (ICC), Bulk Drug Manufacturers’ Association (BDMA); has also offered their support towards the success of the trade show. Gautam Rajan, President of IAIA shared his inputs; “Considering the current trends in the Indian analytical industry; we believe that the industry will further have a steady growth with more and more pharma requirements that is expected in the near future. We are certain that all our exhibitors will definitely benefit from their participation.

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Event Coverage The Anacon-JAIMA Technology Showcase lined up during the exhibition will be a deep dive on the latest developments in Analytical Science and Instrumentation Technologies. The industry experts will deliberate upon the key topics

including; Physical Properties Testing for Fuels and Lubricants, FTIR Spectroscopy and Advanced Applications in Chemical Industry with further discussion on Analytical Solutions for Drug Discovery and Delivery.

Thailand LAB INTERNATIONAL 2019 – Ready to be the Integrated Laboratory Platform in Asia!

Expanding 20% of the Exhibition Space for “Biotechnology” Thailand LAB INTERNATIONAL --the International Trade Exhibition and Conference on Analytical Laboratory Equipment & Technology, Biotechnology & Life Sciences and Chemical & Safety will organize its 9 editions during 25-27 September 2019 at EH102-104, BITEC, Thailand.

The show aims to be one of the leading laboratory

exhibitions and conferences in Southeast Asia.

Having its focus on Analytical & Testing, Clinical & Diagnostic, Research & Development, Calibration & Metrology, Medical Technology and Environmental & Safety.

Last year Thailand LAB INTERNATIONAL 2018 welcomed 9,109 trade visitors from 43 countries and 203 leading companies with more than 650+ Brands displayed. During the exhibition, over 216 potential buyers were invited and had meeting with exhibitors at the Buyer Lounges. It provided 934 business matching sessions especially for biotechnology sector.More than 60 conference session with 100+ topics were organized to capture and update laboratory industry both for academic and industry proposes.

The event brought together visitors and buyers from R&D, QA&QC, purchasing and

management in various industries. Visiting countries included Singapore, China, India, Myanmar, South Korea, Malaysia, Japan, Cambodia, Vietnam, Philippines, Taiwan, United States, Hong Kong, Germany, Spain, the UK, and more.

Thailand LAB INTERNATIONAL has strengthened its promising platform for laboratory technologies and equipment by expanding business opportunities in Life Science & Biotechnology. VNU Exhibitions Asia Pacific as the organizer of Thailand LAB INTERNATIONAL has decided to joint-hands with Thailand Center of Excellence for Life Sciences (TCELS) developing life sciences & biotechnology profile to be an outstanding show called“Bio Investment Asia”at hall 104. It is about 20% of the total exhibition space focusing on: Biopharmaceuticals, Regenerative Medicine, Precision Medicine, Digital Health and Medical Laboratory.TCELS has played the leading role in linking both the public and private sectors to mobilize experts to join Asia Pacific Economic Cooperation (APEC). TCELS join hand with Thailand LAB INTENATIONAL and several partner such as, National Innovation Agency (NIA) and Board of Investment (BOI) and other international partners to concretely promote the innovation in Life Science and Biotechnology.

With an aim to drive Thailand towards being the regional hub of Life Science industry in 2019.

The last chance to secure a space, please visit www.thailandlab.com or www.bioinvestmentasia.com Call +662 670 0900 ext. 202, 206 | Email: thailandlab@vnuexhibitionsap.com| More than 70% of the exhibition space is RESERVED!

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Business News

Manufacturing problems persist for Aurobindo, U.S.' second-largest generics producer When Aurobindo forked over $1 billion to snap up some of Novartis’ unwanted drugs last year, it set the Indian drugmaker up to be the secondlargest generics player in the U.S. But it is one that brings a history of quality issues when it comes to manufacturing, as exemplified in the latest thrashing by the FDA. The agency this week posted a Form 483 for Aurobindo’s plant in Telangana with nearly a dozen observations but one overriding issue, the agency said. The plant’s quality control unit, which should be ensuring products meet the highest standards before shipping to the U.S., doesn’t seem to know what it is doing.

The problems ran a gamut from poorly trained visual inspectors to the company's indifferent treatment of customer complaints about vials that had black particles in them. The company said the particles “were intrinsic” to manufacturing when FDA inspectors indicated they most likely were from shedding stoppers.

Manufacturing issues have been an ongoing concern of the FDA’s when it comes to Aurobindo. The citation came just weeks after a key sterile injectables plant in Pashamylaram, Hyderabad, was written up in December for the second time in two years. Aurobindo has had

similar problems at another sterile manufacturing plant in nearby Bachupally.

The FDA finding comes as the Indian drugmaker has significantly increased its footprint the U.S. generics market with three plants, 750 employees and a portfolio of 300 drugs it acquired in September from Novartis’ Sandoz unit for $1 billion. Those included Sandoz’ U.S. dermatology line.

At the time, Aurobindo managing director N. Govindarajan claimed the deal would make his company the second-largest dermatology player in the U.S. generics market and the second-largest generics company by prescriptions. Of course, it is yet to be seen how Aurobindo will fare with the drugs, given that Sandoz tossed them off for having insufficient margins in a very challenged U.S. generics market.

But Aurobindo is not content to be simply a generics player in the U.S. It pulled off a smaller deal in January when it agreed (PDF) to pay up to $300 million for seven branded injectable cancer drugs from Irvine, California-based Spectrum Pharmaceuticals, along with what it termed a substantial commercial infrastructure to support them.

Story source and credit: https://www.fiercepharma.com by: Eric Palmer

Novartis bribery investigation craters after Greek prosecutors clear 4 officials Greek corruption investigators were looking into charges that Novartis bribed a group of politicians for preferential pricing of its drugs. Now that investigation is falling apart.

On Monday, prosecutors returned a case file to Greek Parliament clearing four politicians in a whistleblower investigation alleging a longrunning bribery scheme between the Swiss drugmaker and 10 politicians from the country’s New Democracy party, Kathimerini reported.

The only name still listed on the file was that of former health minister Andreas Loverdos, but the newspaper reported investigators had found no evidence of Loverdos accepting bribes. The prosecutors' case relies solely on witness testimony, the publication reported.

At least four of the remaining five politicians are expected to be cleared of all charges, the newspaper said, in what New Democracy officials have called a scam led by the country’s governing party, SYRIZA. The case’s collapse comes after a Novartis internal probe in March found no evidence of “inappropriate payments” between company officials and Greek lawmakers. Those findings reflected a report from an expert panel in Greece, which also said last month that they had found no sign of suspicious payments to key officials, Kathimerini reported.

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Business News The bribery allegations, based on three whistleblower accounts, accused Novartis of paying former government officials—including two former prime ministers—millions of euros in exchange for increased sales of its products between 2006 to 2015.

Novartis’ internal probe did not address additional allegations in the suit that the company paid doctors in a kickback scheme to boost prescriptions.

As Novartis’ Greek tragedy unravels, the company is still in hot water with U.S. prosecutors as its earnest CEO Vas Narasimhan has worked to remake the company in his own image.

Last week, a U.S. District judge threw out Novartis’ request for summary judgment in a kickback lawsuit alleging a “companywide” scheme to pay doctors for scripts through sham promotional events.

Among the over-the-top allegations in that suit, prosecutors said Novartis sales officials treated doctors to $10,000 dinners at chic NYC seafood restaurant Nobu, held a promotional event aboard a fishing boat and treated physicians to wild nights at Hooters. That case is expected to go to a jury trial unless a settlement is reached.

Novartis was also flagged by Congress last year after it shelled out $1.2 million to Michael Cohen,

the former personal lawyer and “fixer” for President Donald Trump. Novartis said it made the payments after Cohen approached the drugmaker offering insight into the Trump administration after his inauguration in January 2017. Company officials later said they received nothing from the arrangement.

As those dramas play out, Narasimhan, in his second year as CEO, has targeted M&A spending of $10 billion a year to help build out its pipeline in gene and cell therapy and pursue other "transformative" innovation.

In 2018, Narasimhan spearheaded the acquisitions of gene therapy company AveXis and radiotherapy company Endocyte for $8.7 billion and $2.7 billion, respectively.

Meanwhile, the company has been shedding assets beyond its prescription drug business. Tuesday, the company wrapped up a spinoff of its eye division Alcon, acquired in a 2010 deal engineered by former CEO Daniel Vasella. The company has also sold some of its Sandoz generics business, and it's working to segregate that division from the rest of the company in a move some consider a prelude to a sale.

Story source and credit: https://www.fiercepharma.com by: Kyle Blankenship

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Product Launches

Using Renishaw’s in Via™ Raman Microscope Detecting Counterfeit Coconut Water Coconut water has seen a recent boom in popularity. It's a very lucrative market, with London, England, being the biggest consumer of coconut water in the world (per head).

There are at least 40 brands of coconut water in the United Kingdom alone and it can cost up to £4 per litre.

With only five countrie s in the world supplyi ng the majority of coconut water to the West, this surge in popularity, and resulting imbalance between supply and demand, has led to criminal activity in the supply chain. Scientists at the University of Manchester are using a Renishaw inVia™ confocal Raman microscope to study the adulteration of coconut water.

In 2017 a national food-crime investigation seized 400 tonnes of coconut water at the port of Felixstowe, England. Tests showed that seven out of the twelve brands imported had been adulterated.

Prof. Roy Goodacre, from the Manchester Institute of Biotechnology, heads the group that is conducting research into fake coconut water. His research student, Mr Paul Richardson, used a Renishaw inVia Raman microscope to detect and quantify the adulteration of fresh coconut water, stretched with water-sugar mixtures.

One of the main challenges of this study was to mimic typical adulteration of fresh coconut water, with a water/sugar mix used to maintain a constant sweetness. Using the inVia Raman microscope and chemometrics, they were able to detect adulteration with three different sugar solutions. This confirmed that, with optimisation, Raman spectroscopy has the potential to be used as a fast and reliable screening method for the detection of the stretching of coconut water, even if masked with very low levels of sugar.

When asked why the group chose to use Raman spectroscopy for this research project, Mr Richardson said: “It is a fast and relatively inexpensive analytical method with the potential to be highly portable. Furthermore, it differs from the methods currently in place (SNIF-NMR* and IRMS**) in that it requires no sample preparation, allowing it to potentially be used as an effective screening method at points of entry.”

Mr Richardson continued: “The inVia system is a powerful Raman microscope which, with appropriate training, can allow the user to easily test and use a multitude of different settings including laser strength, acquisition parameters, and grating. The ability to easily test different parameters and optimise our methods gave us more confidence in the detection capabilities of our models. Furthermore, the machine's sensitivity allowed us to provide stronger evidence for our models.

“My favourite aspect of the inVia microscope was the ability to automate sampling. As my work involved sampling multiple sets of 21 samples, I could simply prepare them, load them up on a 96well plate, and run several hours of analyses overnight. Given that I had limited time for research, this allowed me to obtain more highquality results, as I never had to compromise between quality and quantity. Along with those highlighted above, a great advantage of the inVia microscope, compared to other spectrometers I have used, is the small volume required for analysis. While low stock was never an issue for me, working with volumes under 1 ml made my sample sets far easier to generate and keep track of.”

Mr Richardson summarised the use of the inVia microscope for this research by saying: “It is a great tool for research. Along with being a powerful spectrometer with microscopy capabilities, it has a multitude of useful features that simplify research.

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Product Launches The ability to modify various parameters allows for diverse research to be performed on the same machine, and the small volumes required make it ideal for biological research. Finally, the capacity for automation allows for far greater efficiency in data gathering.”

Mr Richardson and his colleagues have recently published a paper on this work: Paul I.C. Richardson, Howbeer Muhamadali, David I. Ellis, Royston Goodacre Rapid quantification of the adulteration of fresh coconut water by dilution and sugars using Raman spectroscopy and chemometrics, Food Chemistry, Vol 272, 2019, Pages 157-164, ISSN 03088146, https://doi.org/10.1016/j.foodchem.2018.0 8.038 Story source / Credit: Renishaw plc

OHAUS® Introduces Newly Redesigned Navigator™ Series Portable Balances Rugged, Multi-Purpose Balances Ideal for a Range of Weighing Applications OHAUS Corporation, a worldwide leader in the manufacturing of highly accurate and reliable weighing and measurement products, laboratory equipment and analytical instruments has announced the launch of their newly redesigned Navigator Portable Balances.

Bringing Accuracy and Repeatability to Any Application The new Navigator series portable balances are designed for a wide-range of essential weighing applications in laboratory, industrial, and education settings.

Combining rugged construction with multifunctionality, the Navigator offers accuracy, speed and repeatability in a powerful, yet affordable balance.

Improved Productivity with Fast Stabilization Time The Navigator is designed to accurately stabilize in less than one second to provide quick and reliable results, improving operator efficiency and productivity throughout the weighing process.

loadsup to four timesthe rated capacity of the unit.

In addition, an integrated shipping lock protects the weighing cell from damage during transportation or storage.

"The Navigator balance fits in a wide variety of applications. Its useful features such as stackability, ultra-fast stabilization time, portability or battery operation combined with a broad selection of capacities and readabilities make it a perfect choice, whether it is for education or industrial use " says Szymon Holubowicz, Senior Market manager at OHAUS. Story source / Credit: Ohaus Europe GmbH

Lonza to Launch the MODA™ ES NextGeneration Electronic Batch Record Execution Platform at the Paperless Lab Academy 2019 Lonza will launch the MODA™ ES Software Platform, a next-generation electronic batch record execution solution, at the Paperless Lab Academy 2019.

Building on Lonza’s extensive informatics knowhow and contract manufacturing expertise, the new platform offers a flexible and user-friendly solution for consolidating and managing batch and quality data generated by non-automated manufacturing processes.

The MODA™ ES Software Platform has been designed to provide a cost-effective solution to batch record challenges.

Overload Protection Safeguards the Balance and Increases Durability The balance’s overload protection system (mechanical and software) is made to withstand Microbioz India, April 2019

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Product Launches Electronic batch records have been unattainable for most of the industry due to cost constraints and flexibility concerns. Lonza is changing that with the launch of the MODA™ ES Platform, which facilitates paperless execution across manufacturing and QC processes. The MODA™ ES Platform equals One Record, One Platform to move companies into the digital age and allow them to reap the benefits of efficiency, improved compliance, real-time reporting and expedited release of products to customers.

“The MODA™ ES Electronic Batch Record Execution Platform builds on Lonza’s unique manufacturing, quality- control and informatics expertise to bring a cost-effective, flexible and

scalable solution to the market,” said Mike Goetter, Head of Global Sales – Bioscience Solutions.

“This platform will enable manufacturing organizations to rapidly scale to a paperless workflow and empower them to make informed decisions while improving efficiency and compliance."

Introducing a different approach to informatics in life-science manufacturing Attendees of the Paperless Lab Academy can learn more about the key features and benefits of Lonza’s new MODA™ ES Software Platform, including: Workflow-driven data entry applicable to batch records, sterility tests and cleaning forms A modular design allowing individual modules to be created, validated and used across different processes

Standard methods for processing products of the same family, with the flexibility to vary the raw materials, fill volumes and equipment types used An electronic checklist enabling realtime review and approval Data integrity alert capability to trigger timely intervention and resolution of issues Seamless integration with other cGMP compliant electronic systems, as well as with analytical equipment, for effortless, reliable data transfer Story source / Credit: Lonza

Avoid blurred image documentation during quality control with Focus Stacking app from TAGARNO One main advantage of using a digital microscope during quality control is how easily operators can create photo documentation of their work.

However, issues arise when the object is not flat, resulting in blurred or out of focus areas on the image. Solution? Stacking photos with varying focus heights on top of each other for one ultrasharp image.

The cameras used in digital microscopes today are of such high quality that it’s easy to create extremely sharp images for documentation purposes. As long as your object is flat, that is.

Simply capturing an image of an object with an irregular surface will create blurred images with out of focus areas, which might not be suitable for documentation material. With the Focus Stacking app from TAGARNO, the operator can create one ultra-sharp image in seconds regardless of the object shape.

Create one ultra-sharp image With Focus Stacking, the operator adjusts the focus height until the object areas furthest away from the camera are in focus. The focus height is then changed to focus on the object areas closest to the camera. Depending on the object, the operator chooses how many pictures the application must capture while moving between the defined focus heights. The app then stacks the photos on top of each other to create one ultrasharp image with no blurred or out of focus areas.

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Product Launches Easy access to high quality images Thanks to the camera and built-in computer, it is easy to capture and store a large amount of photo documentation directly on the TAGARNO microscope. Simply capture an image using the control box and access it using a computer that is connected to the microscope through a LAN connection. If preferred, it is also possible to store the image documentation directly on an USB Memory Stick.

This digitalized approach to quality control not only improves the quality of the work. It also improves communication between colleagues and remote supply chain partners by allowing an operator to quickly share and explain any issue with accompanying images.

About TAGARNO TAGARNOs digital microscopes are used for visual inspection and quality control in a variety of industries worldwide. Using high-definition cameras and user-friendly software interfaces, the digital microscopes magnify, analyze and capture objects in excellent image quality.

Story source / Credit: TAGARNO A/S

Small, yet Perfectly Formed, New Workstation from Don Whitley Scientific Don Whitley Scientific is proud to launch one of their most compact workstations yet, the Whitley A25 Workstation.

The A25 is equipped with many unique features to ensure easy and efficient use and to guarantee that the very best anaerobic conditions are maintained. It has a capacity of 200 Petri dishes while still leaving more than adequate space to process samples in a strictly controlled anaerobic environment.

This workstation is equipped with instant access ports and has a built-in, rapid airlock that can accommodate 20 x 90mmPetri dishes or 3 x 500 ml Duran bottles. The airlock allows items to be transferred into the workstation atmosphere in less than 20 seconds and the doors are interlocked

so cannot be opened simultaneously. Front loading and side loading letterbox entry systems are also available, providing a straightforward way to quickly introduce individual samples into the workstation. The A25 is fitted with a touch screen providing the user with an intuitive interface to control and operate the workstation.

Previously unavailable on a workstation of this size, Whitley Workstations are the only workstations to provide automatic early warnings about the status of the anaerobic atmosphere and catalyst function.

With a wide selection of options available, the A25 can fulfil the needs of any laboratory requiring a compact anaerobic workstation.

A versatile instrument, the A25 can also be used as a microaerobic workstation by simply connecting the relevant pre-mixed gas.

Story source / Credit: Don Whitley Scientific

Photostabillity chamber by Mack Pharmatech Pvt ltd Mack Pharmatech offers cost effective PLC based Photo stability chambers with European standard “CE” in different capacities.

Photo Stability Chambers have Temp. range is 20°C to 50°C, Accuracy : ±0.2°C Uniformity : ±1.0°C &,Control System : PLC (Allen Bradly) .

Mack Pharmatech is the only company who gives all equipment with PLC Based Control System, 21 CFR Software, Test samples on Fluorescent light or UV lights separately as well as simultaneously, Lights automatically shut off after a specified exposure level or time duration, HMI (Touch Screen Display), GSM Technology, Hooter System, Full View Glass Door, Bullet feet leveling legs, GMP Model For more information: Mack Pharmatech Pvt ltd Corporate / Factory Office : B-48, Malegaon MIDC, Sinnar, Nasik, Maharashtra 422 113, INDIA Mobile: +91 93259 65656 Telefax: +91-02551-230877 URL: www.mackpharmatech.com E-Mail: sales@mackpharmatech.com Microbioz India, April 2019

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PUBLISHED ON: 15th April 2019

RNI NUMBER: UPENG/2017/73675