Manufacturing of Pharmaceutical Proteins

Dr. Stefan Behme has been working with biotech operations of Bayer Schering Pharma AG, Germany since 2002, taking care for external manufacturing cooperations for biotechnological production. Before that he spent three years with the Healthcare-Engineering department of Bayer AG, managing biotech investment projects in Germany and the U.S. Stefan received his Master's degree in chemical engineering in 1994 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. Since 2006 Stefan is a lecturer at the University of Dortmund (Germany) teaching GMP aspects of biopharmaceutical manufacturing.

INTRODUCTIONThe role of manufacturing in biotechnology / product classes / fundamentals of biology andbiochemistryTECHNOLOGYProcess: the role of the manufacturing process in biotechnology / process schematic andevaluation / cell bank / fermentation / purification / formulation / labeling and packagingAnalytics: the role of analytics in biotechnology / product analytics / process analytics /analytics of clean room- and sterile media / product comparability / analytical methodsPHARMACOLOGYDrug effects in humans / application routes and forms / drug study / the path of the drug fromthe manufacturer to the patient /drug safetyQUALITY ASSURANCEFundamentals of quality assurance: basic principles / benefit of QA-activities / qualitymanagement according to ISO 9000 / structure of QM-systems and their components in thepharma field / quality assurance during developmentQuality assurance in manufacturing: good manufacturing practice / typical operativeworkflows under GMP / production of investigational drugsPHARMACEUTICAL LAWPharmaceutical law and regulatory authorities / institutions and regulationsPRODUCTION FACILITIESFacility design: GMP-compatible plant design / basic concepts for manufacturing plants /clean- and plant-utilities / cleaning / clean rooms / automation / QC-laboratories / locationfactorsPlanning, construction and commissioning of a manufacturing plant: steps of aconstruction project / time schedules / cost estimates / organization and successful executionof a construction project / regulations for health, safety, environment and buildingsECONOMYSales and costs: drug life cycle / calculation of manufacturing costs and their position in theoverall cost frameworkInvestments: basic principles / investment planning and evaluationManufacturing concept: product demand and plant-capacity usage / the dilemma of internalmanufacturing / aspects of external manufacturing / make-or-buy analysis / processoptimization after market launch / supply-chain managementAPPENDICESLiterature / abbreviations / key words

"It is unusual to find a book of such complexity and diversity written by a single author. Clearly Stefan Behme has been involved in all aspects of manufacture of pharmaceutical proteins whilst at Bayer and Bayer-Schering, and this experience shows in the depth of understanding of each topic, and the inter-relationship between the various sections on technology which includes chapters on the manufacturing process and on analytics, pharmacy, QA, pharmaceutical law, production facilities and economy...The author covers a vast amount of material in the almost 400 pages, and this is valuable, since there are few books on pharmaceutical manufacture. His industrial practice and understanding of the multi-disciplinary nature of modern manufacture shines through each chapter. As a result, a highly readable and comprehensive book has been produced. Highly recommended to those needing an appreciation of industrial manufacturing of biopharmaceuticals." ( Organic Process Research and Development , January 2011)

"This volume will be an excellent introductory course for the subject matter." ( New Biological Books , June 2010)
"A timely addition ... [to] the field of protein production, analytics, biotechnology and regulatory affairs. The clear layout of figures and the use of color, when needed, help the reader to gain a quick understanding of topics such as production planning ... .The large number of topics covered here turns this book into a rich source of information ... .Students can benefit from this book by finding answers quickly and familiarizing themselves with topics usually not presented in one text book. Many others involved in the manufacturing and marketing process of biopharmaceuticals such as lawyers and business developers can learn more about technical aspects of protein production. The author contributes with this book to closing the 'language gap' between all disciplines involved in the highly complex manufacturing process of pharmaceutical proteins." ( ChemMedChem , October 2009)