Manufacturing of pharmaceutical proteins : from technology to economy / Stefan Behme.

Includes bibliographical references and index.

Introduction. Biopharmaceutical Production: Value Creation, Product Types, and Biological Basics Introduction -- Technology -- Technology. Manufacturing Process -- Analytics -- Pharmacy -- Pharmacy. Pharmacology and Drug Safety -- Quality Assurance -- Quality Assurance. Fundamentals of Quality Assurance -- Quality Assurance in Manufacturing -- Pharmaceutical Law -- Pharmaceutical Law. Pharmaceutical Law and Regulatory Authorities -- Production Facilities -- Production Facilities. Facility Design -- Planning, Construction, and Commissioning of a Manufacturing Plant -- Economy -- Economy. Production Costs -- Investments -- Production Concept -- Production Organization and Digitalization -- Production Organization and Digitalization. Organization of a Manufacturing Facility -- Digitalization.

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.

About the Author
Stefan Behme, PhD, 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 the 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.