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Structured like a textbook, the second edition of this reference covers all aspects of biopharmaceutical manufacturing, including legal and regulatory issues, production facility design, and quality assurance, with a focus on supply chain management and regulations in emerging markets and cost control.The author has longstanding industrial expertise in biopharmaceutical production and years of experience teaching at universities. As such, this practical book is ideal for use in academia as well as for internal training within companies.
Sommario
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 Cost CalculationReferencesIndex
Info autore
Dr. Stefan Behme is the department head of Strategic Sourcing Finished Products, Contract Manufacturing at Bayer Healthcare, Berlin. Before that he worked with biotech operations of Bayer, taking care for external manufacturing cooperations for biotechnological production. Stefan started his industrial career with Bayer in the engineering department, managing healthcare investment projects in Germany and the US. From 2006 through 2010 Stefan worked as lecturer at the Universitys of Dortmund (Germany) and Berlin teaching GMP aspects of biopharmaceutical manufacturing and production processes in life sciences. Stefan received his Master's degree in chemical engineering and worked after that as assistant teacher in the field of macromolecular thermodynamics at the Technical University of Berlin where he also earned his PhD degree.
Riassunto
Structured like a textbook, the second edition of this reference covers all aspects of biopharmaceutical manufacturing, including legal and regulatory issues, production facility design, and quality assurance, with a focus on supply chain management and regulations in emerging markets and cost control.
The author has longstanding industrial expertise in biopharmaceutical production and years of experience teaching at universities. As such, this practical book is ideal for use in academia as well as for internal training within companies.
