The latest edition of this highly acclaimed textbook, provides a comprehensive and up-to-date overview of the science and medical applications of biopharmaceutical products. Biopharmaceuticals refers to pharmaceutical substances derived from biological sources, and increasingly, it is synonymous with ‘newer’ pharmaceutical substances derived from genetic engineering or hybridoma technology.
This superbly written review of the important areas of investigation in the field, covers drug production, plus the biochemical and molecular mechanisms of action together with the biotechnology of major biopharmaceutical types on the market or currently under development. There is also additional material reflecting both the technical advances in the area and detailed information on key topics such as the influence of genomics on drug discovery.
Cuprins
Preface.
Chapter 1. Pharmaceuticals, biologies andbiopharmaceuticals.
Chapter 2. The drug development process.
Chapter 3. The drug manufacturing process.
Chapter 4. The cytokines–the interferon family.
Chapter 5. Cytokines: interleukins and tumour necrosisfactor.
Chapter 6. Haemopoietic growth factors.
Chapter 7. Growth factors.
Chapter 8. Hormones of therapeutic interest.
Chapter 9. Blood products and therapeutic enzymes.
Chapter 10. Antibodies, vaccines and adjuvants.
Chapter 11. Nucleic acid therapeutics.
Appendix 1. Biopharmaceuticals thus far approved in the USA or European Union.
Appendix 2. Some Internet addresses relevant to thebiopharmaceutical sector.
Appendix 3. Two selected monographs reproduced from the European Pharmacopoeia with permission from the European Commission: I. Products of recombinant DNA Technology; II.Interferon a -2 concentrated solution.
Appendix 4. Manufacture of biological medicinal products forhuman use. (Annex 2 from The Rules Governing Medicinal Productsin the European Community, Vol. 4, Good Manufacturing Practices for Medicinal Products).
Index.
Despre autor
Gary Walsh is a senior lecturer in industrial biochemistry at the University of Limerick, Ireland. He combines industrial experience within the pharmaceutical industry with an extensive teaching and academic research background in pharmaceutical biotechnology. He has published half a dozen highly acclaimed books on various aspects of protein biotechnology. He is on the editorial board of several biopharmaceutical journals and is closely affiliated with the European Association of Pharma Biotechnology, serving as its scientific secretary.
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