Bücher online kaufen
Manufacturing of Pharmaceutical Proteins
 |
| Der Artikel wird am Ende des Bestellprozesses zum Download zur Verfügung gestellt. |
Artikel-Nr:
9783527683093
Veröffentl:
2015
Einband:
E-Book
Seiten:
456
Autor:
Stefan Behme
eBook Typ:
PDF
eBook Format:
Reflowable E-Book
Kopierschutz:
Adobe DRM [Hard-DRM]
Sprache:
Englisch
Beschreibung:
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.
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.
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