Manufacturing of Pharmaceutical Proteins – From Technology to Economy 3e
Autor S Behmeen Limba Engleză Hardback – 18 ian 2022
The distinguished author provides readers with practical understanding of the terminology and principles driving the various fields involved with biotechnological production, including operations, legal, finance, and IT. He also offers:
- A thorough introduction to biopharmaceutical production, including value creation, product types, and biological basics
- Comprehensive explorations of the technology of the manufacturing process and analytics
- Practical discussions of pharmacology and drug safety, quality assurance, and pharmaceutical law
- In-depth examinations of pharmaceutical protein production facilities, including facility design and the planning, construction, and commissioning of a manufacturing plant
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Specificații
ISBN-13: 9783527349470
ISBN-10: 3527349472
Pagini: 496
Dimensiuni: 177 x 254 x 29 mm
Greutate: 1.1 kg
Ediția:3rd Edition
Editura: Wiley Vch
Locul publicării:Weinheim, Germany
ISBN-10: 3527349472
Pagini: 496
Dimensiuni: 177 x 254 x 29 mm
Greutate: 1.1 kg
Ediția:3rd Edition
Editura: Wiley Vch
Locul publicării:Weinheim, Germany
Cuprins
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