Abstract: Indian Biopharmaceutical Industry Structure - Biotechnology-derived Pharmaceutical Products - Market Research and Pharmacoeconomic analysis - IPR considerations - TECHNICAL ASPECTS - R&D to Production, Product characterization, stability testing - Product evaluation for safety, tolerability and efficacy Product storage and handling - Regulatory considerations - Market Authorization - Global marketing.
Introduction
Biotechnology defined
The FDA defines biotechnological process (biotech) as “the use of cells or organisms that have been generated or modified by genetic engineering, hybridoma, or other technologies used to produce active Biologicals.”. Karl Ereky, the famous Hungarian agriculture economist, was the first to have coined the term, 'Biotechnology' in the year 1919. Modern Biotechnology began with the 1953 discovery of the structure of deoxyribonucleic acid (DNA) by Alfred Hershey and Martha Chase. A year later, James Watson and Francis Crick developed a structural model of DNA. After this discovery, research began on cell function and replication.
Biopharmaceuticals defined
The discovery of recombinant DNA and monoclonal antibody technologies in the 1970 marked the birth of biopharmaceutical industry. Biopharmaceuticals are complex macromolecules derived from recombinant DNA technology, cell fusion, processes involving genetic manipulation or gene cloning. They include recombinant proteins, genetically engineered vaccines, therapeutics monoclonal antibodies and nucleic acid based therapeutics ie Gene therapy vectors. The uses of biotech derived pharmaceuticals can be divided into two categories- therapeutics e.g. rDNA products, monoclonal antibodies, etc. and therapy through genetics. In this article the main focus will be on rDNA products. |
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