Manufacturing of Pharmaceutical Proteins
From Technology to Economy
![Cover](https://www.wiley-vch.de/media/com_eshop/products/resized/no-image-150x150.png)
3. Auflage Januar 2022
496 Seiten, Hardcover
150 Abbildungen (50 Farbabbildungen)
41 Tabellen
Praktikerbuch
Kurzbeschreibung
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.
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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
In parallel he has been passing on his knowledge to students of the Universities of Dortmund (Germany) and Berlin as lecturer for GMP-aspects of biopharmaceutical manufacturing and general life science manufacturing processes. In 2009 he published his first edition of the book "Manufacturing of Pharmaceutical Proteins: from Technology to Economy", which has developed into a popular reference and was followed by a further expanded edition in 2015.