Handbook of Biogeneric Therapeutic Proteins: Regulatory, Manufacturing, Testing, and Patent Issues - Hardcover

9780849329913: Handbook of Biogeneric Therapeutic Proteins: Regulatory, Manufacturing, Testing, and Patent Issues
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More than 20 billion dollars worth of biopharmaceuticals are scheduled to go off-patent by 2006. Given the strong political impetus and the development of technological tools that can answer the questions regulatory authorities may raise, it is inevitable that the FDA and EMEA will allow biogeneric or biosimilar products. Even with all the regulatory wrinkles yet to be ironed out, generic or similar biological products are soon to become a reality.

Handbook of Biogeneric Therapeutic Proteins is the first book to review and analyze the status of biotechnology, regulatory environment, manufacturing methodologies, testing requirements and intellectual property issues. The book provides complete and thorough coverage of the regulatory and technological challenges of developing generic therapeutic proteins and how to prepare detailed regulatory and manufacturing plans and policies. The author includes information on establishing a manufacturing system, securing regulatory approval, and setting up facilities to manufacture raw materials and prepare finished products. He also supplies details about the Chemistry, Manufacturing, and Controls (CMC) section of the FDA's New Drug Application for Biological Products. In brief, the book supplies everything a manufacturer would need to plan the development of biogeneric products and complete the process of regulatory filing.

Waiting for the FDA to issue guidelines is a mistake. The scramble to catch up could leave your company way behind in the game. Your organization needs to begin developing and characterizing genetically modified cells now and to complete initial GMP production runs through a CRO to get ready for the newer testing the FDA might impose. Packed with tables and figures that provide speedy access to precise, timely data, including full formulation details on all FDA approved biological product, this book contains a broad range of resource materials about suppliers, manufacturers, and testing facilities. These features combined with the author's hands-on, practical approach give you the edge you need.

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About the Author:
Dr. Sarfaraz K. Niazi is the Chief Executive of Pharmaceutical Scientist, Inc., a consulting company for pharmaceutical and biotechnology industry. He has been involve in the licensing, technology transfer, process development, and turnkey therapeutic protein manufacturing operations worldwide. Dr. Niazi is also licensed to practice patent law before the US Patent and Trademark office and an inventor with scores of patents on new drugs and drug delivery systems.

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  • PublisherCRC Press
  • Publication date2002
  • ISBN 10 0849329914
  • ISBN 13 9780849329913
  • BindingHardcover
  • Edition number1
  • Number of pages584
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Niazi, S.K.
Published by Taylor & Francis Ltd. (2006)
ISBN 10: 0849329914 ISBN 13: 9780849329913
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Book Description Condition: Good. This is an ex-library book and may have the usual library/used-book markings inside.This book has hardback covers. In good all round condition. No dust jacket. Please note the Image in this listing is a stock photo and may not match the covers of the actual item,1250grams, ISBN:9780849329913. Seller Inventory # 9185741

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