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Manufacturing of Pharmaceutical Proteins – From Technology to Economy 3e

Autor S Behme
en Limba Engleză Hardback – 18 ian 2022
An expert, single-volume overview of the core processes and disciplines of biopharmaceutical production In the newly revised Third Edition of Manufacturing of Pharmaceutical Proteins: From Technology to Economy, renowned chemical engineer Dr. Stefan Behme delivers a comprehensive text covering all aspects of biopharmaceutical manufacturing, including legal and regulatory considerations, production facility design, quality assurance, supply chain management, emerging market regulations, and cost control. Suitable as both a reference book and a training resource, this book extensively explores the impact of digital transformation on pharmaceutical protein manufacturers and includes a brand-new chapter dedicated to digitalization.
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
Perfect for biotechnologists working in the pharmaceutical industry, Manufacturing of Pharmaceutical Proteins: From Technology to Economy will also earn a place in the libraries of pharmaceutical engineers seeking a one-stop reference for all aspects of biopharmaceutical production.
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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

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