edited by June Grindley
and Jill Ogden

Understanding Biopharmaceuticals: Manufacturing and Regulatory Issues offers exceptionally broad coverage of the biopharmaceutical industry from the commercial, regulatory, clinical, and manufacturing points of view. It provides a detailed analysis of the market for biopharmaceuticals and reviews the activities required to take a biopharmaceutical product from the laboratory to the marketplace

Industry experts discuss the status of the biopharmaceutical market in terms of approved recombinant proteins, vaccines, and monoclonal antibodies. They also explore the impact that the human genome sequencing project and associated activities will have on the market and the prospects for "biogeneric" and second-generation versions of certain drugs. Numerous specific examples and case histories support the text.

Contents

1. The Status of the Industry
2. Issues Relating to the Host Expression System
3. Biopharmaceutical Product Development
4. Regulatory & Quality Considerations
5. Preclinical & Clinical Testing
6. Patent Protection of Biopharmaceutical Inventions
7. Future Promise

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