Biopharmaceuticals, an Industrial Perspective

1. Front Matter

   Pages N3-x

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2. Biopharmaceuticals, an overview

   • Gary Walsh

   Pages 1-34

3. Abciximab: The First Platelet Glycoprotein IIb/IIIa Receptor Antagonist

   • Robert E. Jordan, Marian T. Nakada, Harlan F. Weisman

   Pages 35-71

4. Recombinant Coagulation Factor IX (BeneFIX®)

   • John Edwards, Neil Kirby

   Pages 73-108

5. Biopharmaceutical Drug Development: A Case History

   • Mary Ann Foote, Thomas Boone

   Pages 109-123

6. Follitropin beta (Puregon)

   • Henk J. Out

   Pages 125-148

7. Insulin Lispro (Humalog)

   • Ronald E. Chance, N. Bradly Glazer, Kathleen L. Wishner

   Pages 149-171

8. Interferon beta-1b — the first long-term effective treatment of relapsing-remitting and secondary progressive multiple sclerosis (MS)

   • R. Horowski, J.-F. Kapp, M. Steinmayr, St. Stuerzebecher

   Pages 173-184

9. Reteplase, a recombinant plasminogen activator

   • Michael Waller, Ulrich Kohnert

   Pages 185-216

10. Stabilisation of biopharmaceutical products and finished product formulations

    • Maninder S. Hora, Bao-lu Chen

    Pages 217-248

11. Patent Law for Biopharmaceuticals

    • R. Stephen Crespi

    Pages 249-267

12. The development of new medicines: an overview

    • John C. Stinson

    Pages 269-287

13. The EMEA and regulatory control of (bio)pharmaceuticals within the European Union

    • Gary Walsh

    Pages 289-310

14. Biopharmaceutical Validation: an overview

    • Stephen Slater

    Pages 311-335

15. Validation of Biopharmaceutical Chromatography Systems

    • K. F. Williams, C. J. A. Davis

    Pages 337-362

16. Validation of Water for Injections (WFI) for Biopharmaceutical Manufacture

    • Paschal Baker, Wael Allan

    Pages 363-387

17. Information retrieval and the biopharmaceutical industry: an introductory overview

    • Patricia O’Donnell

    Pages 389-404

18. Information technology and the internet as a resource of biopharmaceutical information

    • J. P. Jenuth, D. Fieldhouse, J. C.-M. Yu

    Pages 405-419

19. Marketing Issues for the (Bio)pharmaceutical sector

    • Scott Spinka

    Pages 421-441

20. Viral mediated gene therapy

    • Brendan Murphy

    Pages 443-469

Biopharmaceuticals, an Industrial Perspective provides a unique and up-to-date insight into the biopharmaceutical industry. Largely written by industrial authors, its scope is multidisciplinary. Several chapters overview the production and medical applications of specific biopharmaceuticals. Other chapters detail additional relevant issues, including the stabilisation of biopharmaceutical products, EU biopharmaceutical regulatory affairs and biopharmaceutical patent law. A series of four chapters reviews important validation issues as applied to biopharmaceutical manufacturing. Additional issues considered include biopharmaceutical information technology as well as viral and non-viral gene therapy.
The book is of particular relevance to scientists and allied professionals already employed in the biopharmaceutical industry, or to those seeking employment within this industry. Its scope also renders it an ideal reference source for students undertaking advanced undergraduate or postgraduate courses in biotechnology, pharmaceutical science, biochemistry or medicine.

• biochemistry
• biotechnology
• chemistry
• chromatography
• gene therapy
• protein

• University of Limerick, Limerick, Ireland

  Gary Walsh

• Limerick Institute of Technology, Limerick, Ireland

  Brendan Murphy

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