Manufacturing of Pharmaceutical Proteins

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.

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 INTRODUCTIONBiopharmaceutical Production: Value Creation, Product Types and Biological BasicsPART 2 TECHNOLOGYManufacturing ProcessAnalyticsPART 3 PHARMACYPharmacology and Drug SafetyPART 4 QUALITY ASSURANCEFundamentals of Quality AssuranceQuality Assurance in ManufacturingAppendix A: Case Study Part IV: Warning Letters by FDAPART 5 PHARMACEUTICAL LAWPharmaceutical Law and Regulatory AuthoritiesAppendix B: Case Study Part V: Clinical Trials for Protein ProductsPART 6 PRODUCTION FACILITIESFacility DesignPlanning, Construction and Commissioning of a Manufacturing PlantPART 7 ECONOMYProduction CostsInvestmentsProduction ConceptAppendix C: Examples Part VII: Manufacturing CostPart 8 PRODUCTION ORGANISATION AND DIGITALIZATION13 Organisation and Core Processes of a Manufacturing Facility14 Digitalization