Manufacturing of pharmaceutical proteins: from technology to economy

This comprehensive introduction to all aspects of manufacturing biopharmaceuticals is a must-have for all biotech companies as well as being equally suitable for academic teaching and internal training in large pharmaceutical or biotech companies. INDICE: 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 toISO 9000 / structure of QM-systems and their components in the pharma field /quality assurance during development Quality assurance in manufacturing: goodmanufacturing 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 Literature / abbreviations / key words

• ISBN: 978-3-527-32444-6
• Editorial: Wiley-VCH
• Encuadernacion: Cartoné
• Páginas: 404
• Fecha Publicación: 14/01/2009
• Nº Volúmenes: 1
• Idioma: Inglés