Manufacturing of Pharmaceutical Proteins: From Technology to Economy

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. INDICE: 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 Calculation.References.Index.

• ISBN: 978-3-527-33766-8
• Editorial: Wiley VCH
• Encuadernacion: Cartoné
• Páginas: 424
• Fecha Publicación: 08/04/2015
• Nº Volúmenes: 1
• Idioma: Inglés