Manufacturing of Pharmaceutical Proteins - From Technology to Economy
Reduzierte Artikel in dieser Kategorie
| Verlag | Wiley-VCH |
| Auflage | 3. Auflage, Januar 2023 |
| Seiten | 496 |
| Format | 17,5 x 2,9 x 25,0 cm |
| Gewicht | 1108 g |
| Artikeltyp | Englisches Buch |
| ISBN-10 | 3527349472 |
| EAN | 9783527349470 |
| Bestell-Nr | 52734947A |
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.
Inhalt:
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
