Advances in Biopharmaceutical Technology in India
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Chapter 12:   Development of Plasma-Derived Biopharmaceuticals in India

Abstract:
In 1989 the Indian Government suspended manufacturing licences for blood plasma products pending process changes by manufacturers to implement viral inactivation to improve the safety of plasma derivatives. This move initiated the end of commercial blood donation and plasma fractionators ceased operations. In 2006, collection of recovered plasma has commenced and there is now a limited product supply from contract fractionation of Indian plasma. India faces a choice of technologies for plasma fractionation. Domestic fractionation needs to be seen as a new endeavour in India and therefore technology transfer of process technology as well as analytical methods is critical to success. The Indian market is only 0.25% of the global plasma products market. Plasma fractionators in India face a major challenge with low price imports. Economic pressures mean pressures on technology to deliver multiple products from high yielding processes. The country must support more than one fractionation plant to even begin to meet the needs of the Indian population. The challenges in relation to current healthcare development and the immensity of the issues in a country of 1.1 billion people are discussed in the HIV context are discussed. India is a country of major opportunity and boasts advantages in science and education, biopharmaceutical R & D, productivity and a low age population. However, the sciences and technologies particular to plasma fractionation are generally lacking even if skills in biopharmaceutical development and manufacturing are present. Investment and processing costs are similar, independent of the technologies chosen since the bulk of the cost is associated with downstream processing and viral inactivation procedures. The greatest threat to failure is likely to be an insufficiently funded project but the key to success will be a dedicated, organized team of Indian scientists and technologists.

About the Authors:

John M. Curling
John Curling Consulting AB
Uppsala, Sweden

Christopher P. Bryant
ProMetic BioTherapeutics, Inc.
Bourbonnais, IL USA

Timothy K. Hayes
ProMetic BioTherapeutics, Inc.
Gaithersburg, MD 20877, USA

Ranjeet S. Ajmani
Celestial Biologicals Ltd.
Ahmedabad, Gujarat, India


John Curling
John Curling works as an independent consultant and, among other consultancies, is currently Senior Advisor/Scientist and Consultant with ProMetic BioTherapeutics, Inc. He is also a member of the Scientific Advisory Board of the company. After graduating in chemistry from the University of Sussex, UK, John Curling joined Pharmacia to work on laboratory and industrial purification in 1967. He started in process chromatography in 1972 and was President of Pharmacia’s Process Separation Division from 1984 until 1990. Research on blood plasma proteins was carried out primarily during the period 1972-1982. In the late 1980s he worked to help establish the National Plasma Fractionation Centre at the KEM Hospital in Mumbai in a project that was partly funded by the Swedish Development Agency, SIDA. He is the author of numerous publications on process chromatography and was a contributor and editor of “Methods of Plasma Protein Fractionation”. He is on the Editorial Advisory Board of “BioPharm International”. John Curling was Chairman of the Board of the ‘‘Recovery Conference Series’’ from 2001 to 2003. He has also worked as a Temporary Advisor and Consultant to the World Health Organisation South East Asia Region on technologies for blood plasma fractionation.

Christopher Bryant
Dr. Christopher Bryant joined ProMetic Life Sciences in 2003, as Project Director of the Plasma Protein Purification System (PPPS), a co-development project with the American Red Cross (ARC) and is now Chief Operating Officer of ProMetic BioTherapeutics, Inc., which integrated the operations of the ARC Plasma Derivatives research group into the ProMetic Group. Dr. Bryant has some 18 years of experience in pharmaceutical development. His expertise encompasses all phases of drug development, from the discovery to the marketing stage. Before joining ProMetic, Dr. Bryant worked for Aventis Behring where he was Senior Director and Head, Pre-clinical R & D and later Senior Director, US Technical Operations. Before joining Aventis Behring (previously Armour and then Centeon) he was a scientist at Eli Lilly & Company and then Boehringer Mannheim Corporation. Dr. Bryant holds a B.Sc. from the University of Northern Iowa, and a M.Sc. and Ph.D. in chemistry from the University of California, San Diego. He holds two patents, has authored close to twenty scientific publications and has been invited to present at many prestigious scientific conferences.

Timothy Hayes
Dr. Timothy K. Hayes is Vice President of Analytical Chemistry, Quality and Regulatory Affairs at ProMetic BioTherapeutics where he is responsible for leading regulatory strategy for product development, characterization and documentation. Dr. Hayes brings some 27 years experience in protein chemistry, plus quality and regulatory affairs. Prior to joining ProMetic, Dr. Hayes was the Director of Analytical Chemistry & QRA, Plasma Derivatives Department, American Red Cross. Dr. Hayes joined the ARC in 2001. He was instrumental in the emergency IND filing for the Hemostatic Dressing contracted by the US Army and used by Special Forces troops in Iraq after being manufactured at CSL, Melbourne, Australia with contributions from ZLB, Bern, Switzerland. Prior to his term at the ARC, Dr. Hayes spent nearly 5 years at Bayer Biological Products (now Talecris Biotherapeutics) in North Carolina as Section Head for Analytical Chemistry and later as Project Leader for the Plasma-Protein Specified Products Initiative. He was important in several projects at Bayer including work on several plasma-derived and recombinant protein products (FVIII). Prior to moving to Bayer, he was Associate Professor and Director of the Biotechnology Support Facility at Texas A&M University where he had previously received his Ph.D. in Chemistry and before that his B.S. in Biology from the University of Houston. Dr. Hayes’ professional activities included working in conjunction with Industry Groups (PPTA and CASSS) and the FDA (WCBP Workshops and CMC Strategy Forums) to enhance the characterization of plasma products and process intermediates by applying these concepts to comparability and PAT approaches. Currently, he serves on the USP Blood and Blood Products Expert Committee, as chair of the Plasma Protein Analytical Advisory Panel, the Editorial Review Board of BioProcess International, and is on the Program Committee for the Plasma Products Biotechnology Conference. He holds two patents, has authored over 100 scientific publications and has been invited to present at many scientific conferences.

Ranjeet Ajmani
Dr. Ranjeet S. Ajmani holds an M. Sc. in Biochemistry from the Holkar Science College, Indore, India and a Ph. D. in biomedical engineering from the Indian Institute of Technology (IIT), Mumbai, India. He continued research at National Institutes of Health, Maryland, USA. He currently holds the position of Chief Scientific Officer, Celestial Biologicals Ltd., a subsidiary of Intas Pharmaceuticals, Ahmedabad, India. Prior to joining Intas/Celestial, Dr. Ajmani was Assistant Professor at the Department of Biochemistry, PGI, Chandigarh, Research Associate, School of Biomedical Engineering, Indian Institute of Technology, Bombay, India. He was Program Associate, Health and Population Education Unit, Ministry of Human Resource Development, Government of India and Assistant Professor, School of Biochemistry, University of Indore, India. Ranjeet Ajmani has published peer reviewed articles and is a member of the New York Academy of Sciences, the International Society of Clinical Hemorheology, the International Society of Biorheology, the American Aging Association and the National Biomedical Engineering Society.

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Eric Langer
BioPlan Associates, Inc.
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