Sie sind bereits eingeloggt. Klicken Sie auf 2. tolino select Abo, um fortzufahren.
Bitte loggen Sie sich zunächst in Ihr Kundenkonto ein oder registrieren Sie sich bei bücher.de, um das eBook-Abo tolino select nutzen zu können.
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.
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. In 2009 he published the book "Manufacturing of Pharmaceutical Proteins - from Technology to Economy". 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.
Inhaltsangabe
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
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
Es gelten unsere Allgemeinen Geschäftsbedingungen: www.buecher.de/agb
Impressum
www.buecher.de ist ein Shop der buecher.de GmbH & Co. KG i.I. Bürgermeister-Wegele-Str. 12, 86167 Augsburg Amtsgericht Augsburg HRA 13309