Biopharmaceutical Manufacturing, Volume 1
Regulatory processesThis two-volume set provides a comprehensive guide to the
essential aspects of commercial biopharmaceutical manufacturing. Covering the
planning, layout and operation of successful commercial manufacturing, the aim
of the books is to enable innovations, new drug development, and make
affordable biological drugs available to patients worldwide. This volume covers the
regulatory processes involved in producing a GMP (Good Manufacturing Practice) biopharmaceutical
product for commercial distribution, including areas of current GMP,
registration, and legal and ethical considerations. Emerging trends in the
technology and regulatory compliance are also discussed, with advice on
establishing efficient manufacturing facilities. Intended for practitioners in the commercial biopharmaceutical
manufacturing industry, the text is an ideal resource for practitioners looking
to develop their ability to manufacture biopharmaceutical products at a large
scale.Key Features:
Covers the essential aspects
of commercial biopharmaceutical manufacturing for industry practitioners,
including the planning, layout and operationProvides sufficient information for industry practitioners to
establish and operate GMP (Good Manufacturing Practice) compliant manufacturing
operationsIncludes case studies and step-by-step procedures for
manufacturing specific biopharmaceutical productsFocused exclusively on products intended for human useIncludes coverage of regulatory requirements, intellectual
property challenges, training of manufacturing teams and issues around cost
optimisation
ISBN: 9780750331739, 0750331739
