Manufacturing of Pharmaceutical Proteins: From Technology to Economy / Edition 1

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Overview

This comprehensive introduction covers all aspects of biopharmaceutical manufacturing, including legal and regulatory issues as well as costing procedures. Written by a leading expert at one of the largest pharmaceutical companies worldwide, this practical text is aimed at a wide audience, ranging from libraries, via biotech companies to students and technicians planning to enter biopharmaceutical manufacturing. In addition, it is well suited for academic teaching as well as internal training within larger biotech or pharmaceutical companies.
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Editorial Reviews

From the Publisher
"It is unusual to find a book of such complexity and diversity written by a single author. Clearly Stefan Behme has been involved in all aspects of manufacture of pharmaceutical proteins whilst at Bayer and Bayer-Schering, and this experience shows in the depth of understanding of each topic, and the inter-relationship between the various sections on technology which includes chapters on the manufacturing process and on analytics, pharmacy, QA, pharmaceutical law, production facilities and economy...The author covers a vast amount of material in the almost 400 pages, and this is valuable, since there are few books on pharmaceutical manufacture. His industrial practice and understanding of the multi-disciplinary nature of modern manufacture shines through each chapter. As a result, a highly readable and comprehensive book has been produced. Highly recommended to those needing an appreciation of industrial manufacturing of biopharmaceuticals." (Organic Process Research and Development, January 2011)

"This volume will be an excellent introductory course for the subject matter." (New Biological Books, June 2010)

“A timely addition … [to] the field of protein production, analytics, biotechnology and regulatory affairs. The clear layout of figures and the use of color, when needed, help the reader to gain a quick understanding of topics such as production planning … .The large number of topics covered here turns this book into a rich source of information … .Students can benefit from this book by finding answers quickly and familiarizing themselves with topics usually not presented in one text book. Many others involved in the manufacturing and marketing process of biopharmaceuticals such as lawyers and business developers can learn more about technical aspects of protein production. The author contributes with this book to closing the ‘language gap’ between all disciplines involved in the highly complex manufacturing process of pharmaceutical proteins.” (ChemMedChem, October 2009)

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Product Details

  • ISBN-13: 9783527324446
  • Publisher: Wiley
  • Publication date: 2/24/2009
  • Edition description: New Edition
  • Edition number: 1
  • Pages: 404
  • Product dimensions: 6.90 (w) x 9.60 (h) x 1.00 (d)

Meet the Author

Dr. Stefan Behme has been working with biotech operations of Bayer Schering Pharma AG, Germany since 2002, taking care for external manufacturing cooperations for biotechnological production. Before that he spent three years with the Healthcare-Engineering department of Bayer AG, managing biotech investment projects in Germany and the U.S.
Stefan received his Master's degree in chemical engineering in 1994 and worked after that as assistant teacher in the field of macromolecular thermodynamics at the Technical University of Berlin where he also earned his PhD degree.
Since 2006 Stefan is a lecturer at the University of Dortmund (Germany) teaching GMP aspects of biopharmaceutical manufacturing.
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Table of Contents

INTRODUCTION
Biopharmaceutical Production: Value Creation, Product Types and Biological Basics
TECHNOLOGY
Manufacturing Process
Analytics
PHARMACY
Pharmacology and Drug Safety
QUALITY ASSURANCE
Fundamentals of Quality Assurance
Quality Assurance in Manufacturing
PHARMACEUTICAL LAW
Pharmaceutical Law and Regulatory Authorities
PRODUCTION FACILITIES
Facility Design
Planning, Construction and Commissioning of a Manufacturing Plant
ECONOMY
Product Sales and Manufacturing Costs
Investments
Production Concept
Appendix: Index of Abbreviations
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