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Regulatory practice for biopharmaceutical production

Author: Anthony S Lubiniecki; Susan A Vargo
Publisher: New York : Wiley-Liss, ©1994.
Edition/Format:   Print book : EnglishView all editions and formats
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Genre/Form: Legislation
Additional Physical Format: Online version:
Regulatory practice for biopharmaceutical production.
New York : Wiley-Liss, ©1994
(OCoLC)624065469
Material Type: Internet resource
Document Type: Book, Internet Resource
All Authors / Contributors: Anthony S Lubiniecki; Susan A Vargo
ISBN: 047104900X 9780471049005
OCLC Number: 29954408
Description: ix, 555 pages : illustrations ; 24 cm
Contents: 1. Introduction to Regulatory Practice in Novel Biotechnology / Anthony S. Lubiniecki and Susan A. Vargo --
2. A U.S. View of New Biotechnology Regulation / Henry I. Miller --
3. Genetic Stability of Host Cell and Product / Michael E. Wiebe and Norm S. Lin --
4. Continuous Cell Lines and Contaminant Testing / Carol J. Marcus-Sekura and Robert W. Kozak --
5. An Evaluation of the Methods and Approaches Used in the Characterization of Recombinant Polypeptides for Human Pharmaceutical Use / Gregory C. Davis, Henry A. Havel, Paul M. Kovach, Ralph M. Riggin, John K. Towns, David P. Allen and James J. L'Italien --
6. Quality Control Issues for the New Biotechnology / Susan A. Vargo --
7. Strategic Decisions in Process Design / Anthony S. Lubiniecki --
8. Regulatory Aspects of Protein Pharmaceutical Formulation / Por-Hsiung Lai --
9. Interferon [alpha]-2b: An Overview from a Regulatory Perspective / Tattanahalli L. Nagabhushan and Alexander Giaquinto. 10. Regulatory Issues Concerning Orthoclone OKT3 (Muromonab CD3) Monoclonal Antibody / Wendy W. Lime --
11. Experience in Manufacturing, Testing, and Licensing a Hepatitis B Vaccine Produced by Recombinant Technology / Arthur Y. Elliott, Wayne Morges and Margit G. Olson --
12. Monoclonal Antibody Purification of Factor VIII / William A. Fricke --
13. Tissue Plasminogen Activator: Regulatory Issues / Deborah Beebe and Genesio Murano --
14. Evaluation of Recombinant Human Erythropoietin as a Therapeutic Agent / Joseph C. Fratantoni and Kenneth B. Seamon --
15. Recombinant Coagulation Factors: New Products, New Problems, and New Solutions / David L. Aronson --
16. Recombinant Peptide Hormones / Yuan-yuan H. Chiu --
17. Cytokine and Growth Factor Products / Linda W. Dujack and Kathryn C. Zoon --
18. Licensing Biotechnology Facilities / Rebecca A. Devine --
19. Water Systems for Biotechnology Facilities / Nancy A. Roscioli, Amy M. Scott and Michael G. Beatrice. 20. Design Considerations for Fermentation and Harvest Equipment / Richard Wisniewski and Chris Burman --
21. Microheterogeneity of Biological Products / Malcolm Moos, Jr. and Kenneth B. Seamon --
22. Computerized Systems Validation / Ron Branning --
23. Regulatory Aspects of Contract Manufacturing / William R. Srigley --
24. The Approval Process within the European Economic Community for Drugs Derived from Biotechnology / John N. Gardner --
25. Regulation of Pharmaceuticals in Japan / Mark D. Dibner --
26. Unresolved Issues / Thomas L. Copmann and John C. Petricciani.
Responsibility: edited by Anthony S. Lubiniecki and Susan A. Vargo.
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