This comprehensive introduction covers all aspects of biopharmaceutical manufacturing, including technology and facilities, GMP and regulatory issues, as well as costing and timeline aspects for supply chain implementation. 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, 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.
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
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.