Understanding Biopharmaceuticals: Manufacturing and Regulatory Issues

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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,...

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More About This Book

Overview

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.

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Editorial Reviews

Booknews
Looks in depth at how biotechnology has affected drug discovery, development, production, and drug delivery, and how new technology has provided the world with new protein therapeutics. Discusses the current status of the biopharmaceutical market in terms of approved recombinant proteins, vaccines, and monoclonal antibodies, and overviews the process of taking a biopharmaceutical product from laboratory to marketplace. Examines regulatory and quality considerations from US, European, and Japanese perspectives, and discusses patentability issues, concluding with a look at the future of the industry. Grindley is a geneticist by training, and heads a consulting company that provides services to biopharmaceutical companies. Ogden lectures in biotechnology at various UK universities. Annotation c. Book News, Inc., Portland, OR (booknews.com)
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Product Details

  • ISBN-13: 9781574910834
  • Publisher: Taylor & Francis
  • Publication date: 12/31/1999
  • Pages: 342
  • Product dimensions: 6.40 (w) x 9.60 (h) x 1.01 (d)

Table of Contents

The Status of the Industry, J. Grindley & J. Ogden Issues Relating to the Host Expression System, J. Ogden Biopharmaceutical Product Development, K. Grant & B. Turner Regulatory & Quality Considerations, K. Lambert Preclinical & Clinical Testing, J. Steiner Patent Protection of Biopharmaceutical Inventions, J. Miles Future Promise, J. Grindley & J. Ogden

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