Manufacturing of pharmaceutical proteins

This comprehensive introduction to all aspects of biopharmaceutical manufacturing, including legal and regulatory issues as well as costing procedures. Written by a leading expert at one of the largest pharmaceutical companies worldwide, this practical text is aimed at a wide audience, ranging from libraries, via biotech companies to students and technicians planning to enter biopharmaceutical manufacturing. In addition, it is well suited for academic teaching as well as internal training within larger biotech or pharmaceutical companies.

INTRODUCTION. The role of manufacturing in biotechnology, product classes, fundamentals of biology and biochemistry. TECHNOLOGY. Process: the role of the manufacturing process in biotechnology, process schematic and evaluation, cell bank, fermentation, purification, formulation, labeling and packaging. Analytics: the role of analytics in biotechnology, product analytics, process analytics, analytics of clean room- and sterile media, product comparability, analytical methods. PHARMACY. Drug effects in humans, application routes and forms, drug study, the path of the drug from the manufacturer to the patient, drug safety. QUALITY ASSURANCE. Fundamentals of quality assurance: basic principles, benefit of QA-activities, quality management according to ISO 9000, structure of QM-systems and their components in the pharma field, quality assurance during development. Quality assurance in manufacturing: good manufacturing practice, typical operative. workflows under GMP, production of investigational drugs. PHARMACEUTICAL LAW. Pharmaceutical law and regulatory authorities, institutions and regulations. PRODUCTION FACILITIES. Facility design: GMP-compatible plant design, basic concepts for manufacturing plants, clean- and plant-utilities, cleaning, clean rooms, automation. QC-laboratories, location. factors. Planning, construction and commissioning of a manufacturing plant: steps of a construction project, time schedules, cost estimates, organization and successful execution of a construction project, regulations for health, safety, environment and buildings. ECONOMY. Sales and costs: drug life cycle, calculation of manufacturing costs and their position in the. overall cost framework. Investments: basic principles, investment planning and evaluation. Manufacturing concept: product demand and plant-capacity usage, the dilemma of internal manufacturing, aspects of external manufacturing, make-or-buy analysis, process. optimization after market launch, supply-chain management. APPENDICES.