Manufacturing of Pharmaceutical Proteins

From Technology to Economy

Stefan Behme (Autor)

Online Resource

404 Seiten

2009
Blackwell Verlag GmbH (Hersteller)
978-3-527-62769-1 (ISBN)

Infos

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.

Autor

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.

Inhalt

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

Produkt-Details

• Erscheint lt. Verlag: 18.6.2009
• Verlagsort: Berlin
• Sprache: englisch
• Themenwelt: Technik
• ISBN-10: 3-527-62769-3 / 3527627693
• ISBN-13: 978-3-527-62769-1 / 9783527627691
• Zustand: Neuware