Manufacturing of Pharmaceutical Proteins

From Technology to Economy
Third Auflage
ISBN: 978-3-527-34947-0
Verlag: Wiley-VCH GmbH

Buch, Englisch, 496 Seiten, Format (B × H): 174 mm x 250 mm, Gewicht: 1104 g

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.

Autoren/Hrsg.

Behme, Stefan

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Pharmazie
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Biotechnologie Medizinische Biotechnologie
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie
• Naturwissenschaften Biowissenschaften Proteinforschung
• Naturwissenschaften Chemie Chemie Allgemein Pharmazeutische Chemie, Medizinische Chemie
• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Pharmaindustrie

Inhaltsverzeichnis

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
Part 8 PRODUCTION ORGANISATION AND DIGITALIZATION
13 Organisation and Core Processes of a Manufacturing Facility
14 Digitalization
 

Über Autor(innen)

Dr. Stefan Behme has held several positions within the pharma and biotech industry over the last 20 years with Bayer AG and former Schering AG, Germany. Trained as chemical engineer, his industrial assignments included: managing healthcare investment projects in Germany and the US, biotech manufacturing operations, strategic sourcing of finished pharmaceuticals, and quality assurance in one of the world's largest drug manufacturing facilities.
In parallel he has been passing on his knowledge to students of the Universities of Dortmund (Germany) and Berlin as lecturer for GMP-aspects of biopharmaceutical manufacturing and general life science manufacturing processes. In 2009 he published his first edition of the book "Manufacturing of Pharmaceutical Proteins: from Technology to Economy", which has developed into a popular reference and was followed by a further expanded edition in 2015.