Short description This comprehensive introduction to all aspects of manufacturing biopharmaceuticals is a must-have for all biotech companies as well as being equally suitable for academic teaching and internal training in large pharmaceutical or biotech companies.
From the 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