Manufacturing of Pharmaceutical Proteins
From Technology to Economy
Manufacturing of Pharmaceutical Proteins
From Technology to Economy
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
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
| ISBN | 9783527349470 |
|---|---|
| Artikelnummer | 9783527349470 |
| Medientyp | Buch |
| Auflage | 3. Aufl. |
| Copyrightjahr | 2022 |
| Verlag | Wiley-VCH |
| Umfang | 496 Seiten |
| Abbildungen | 100 SW-Abb., 50 Farbabb., 41 Tabellen |
| Sprache | Englisch |
