Advances in Biopharmaceutical Technology in India
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Chapter 14:   Application of Recent Advances in Immunology for Developing Novel Biotherapeutics

Immunity is a major barrier in the translational development of bio-pharmaceutical drugs. The US Food and Drug Administration estimates a cost saving of US$100 Million if the human safety of new drugs could be predicted with 10% accuracy. The recent advances in the fundamentals of immunology have assigned a host protective role to Factor H. Factor H is an immune regulatory protein of a billion year old early human defense system such as Alternate Complement System. The Alternate Complement System plays a crucial role in activating host inflammatory and memory responses when foreign material such as bacteria, viruses, cancer cells, allogenic and xenogenic somatic cells, biotherapeutics drugs or bioterrorism related organisms interact with host and its immune system. The potential of Factor H modulation to develop novel bio-pharmaceutical products to prevent, treat and control global diseases is detailed. Large drug companies are looking to developing countries such as India for cost-effective clinical development of novel biotherapeutic drugs such as vaccines for HIV/AIDS. India offers the necessary legal and scientific framework for multinational companies with product patents to develop novel biotherapeutic products cost-effectively.

About the Authors:

Kumar Shah, MD, President
Endocrine Technology, LLC
Brooklyn, NY 11217

Amit Shah, Scientific Officer Department of Research and Development
Endocrine Technology, LLC
Brooklyn, NY 11217

Kumar Shah , MD is a Founder and President of Endocrine Technology, LLC in NY, USA. He has over 20 publications and several patents related to the modulation of Factor H. He is a Diplomat in Internal medicine, Diabetes, Endocrinology and Metabolism. He is in active consulting practice. In India he served as clinical research physician for Roche Products and acted as a consultant to initiate “Cell Transplant Laboratory for the cure of diabetes” for the institute of kidney diseases, Ahmedabad, Gujarat State. He has presented paper in National HIV/AIDS conferences held in Mumbai (HIV Congress: 11-13th March, 2005).

Amit Shah is a scientific officer of Endocrine Technology, LLC. He is involved in developing immune modulation technology of the Company and in the management of information technology. He has a degree in computer sciences and research interests in biotechnology field.

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Eric Langer
BioPlan Associates, Inc.
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