Manufacturing of Pharmaceutical Proteins: From Technology to Economy

ISBN-13: 9783527349470 / Angielski / Twarda / 2022 / 496 str.

Stefan Behme

Spis treści

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

O autorze

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.