Behme Manufacturing of Pharmaceutical Proteins

From Technology to Economy
1. Auflage 2009
ISBN: 978-3-527-62768-4
Verlag: Wiley-VCH
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 390 Seiten, E-Book

Alles über die Herstellung biopharmazeutischer Produkte -- von der Technologie über juristische Aspekte bis zu Fragen der Kostenrechnung -- erfahren Sie aus dieser umfassenden, von einem Experten eines der weltweit führenden Pharmaunternehmen verfassten Band. Durch seinen starken Bezug auf die Praxis eignet sich das Buch nicht nur für Studenten und Dozenten, sondern auch für technisches Personal in Biotech-Unternehmen.

Autoren/Hrsg.

Behme, Stefan

Inhaltsverzeichnis

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

Über Autor(innen)

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.