Now in its third edition, the text covers all aspects of biopharmaceutical manufacturing. Structured like a textbook, it is aimed at a wide audience in industry and academia and can be used as a reference as well as for training purposes.

PART 1 INTRODUCTION
Biopharmaceutical Production: Value Creation, Product Types and Biological Basics
PART 2 TECHNOLOGY
Manufacturing Process
Analytics
PART 3 PHARMACY
Pharmacology and Drug Safety
PART 4 QUALITY ASSURANCE
Fundamentals of Quality Assurance
Quality Assurance in Manufacturing
Appendix A: Case Study Part IV: Warning Letters by FDA
PART 5 PHARMACEUTICAL LAW
Pharmaceutical Law and Regulatory Authorities
Appendix B: Case Study Part V: Clinical Trials for Protein Products
PART 6 PRODUCTION FACILITIES
Facility Design
Planning, Construction and Commissioning of a Manufacturing Plant
PART 7 ECONOMY
Production Costs
Investments
Production Concept
Appendix C: Examples Part VII: Manufacturing Cost
Part 8 PRODUCTION ORGANISATION AND DIGITALIZATION
13 Organisation and Core Processes of a Manufacturing Facility
14 Digitalization

Behme, Stefan

Publications by Behme, Stefan

ISBN	9783527349470
Article number	9783527349470
Media type	Book
Edition number	3. Aufl.
Copyright year	2022
Publisher	Wiley-VCH
Length	496 pages
Illustrations	100 SW-Abb., 50 Farbabb., 41 Tabellen
Language	English