Biopharmaceutical Manufacturing, Volume 2

This 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 unit processes involved in producing a GMP (Good Manufacturing Practice) biopharmaceutical product, laid out in the order of operation, with complete details on equipment, compliance and yield improvement suggestions. The unit processes described include several emerging trends and advice on reducing the costs of the product and efficient scale up techniques. 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. Volume 1 is available here. Key features • Covers the essential aspects of commercial biopharmaceutical manufacturing for industry practitioners, including the planning, layout and operation. • Provides sufficient information for industry practitioners to establish and operate GMP (good manufacturing practice) compliant manufacturing operations. • Includes case studies and step-by-step procedures for manufacturing specific biopharmaceutical products. • Focused exclusively on products intended for human use. • Includes coverage of regulatory requirements, intellectual property challenges, training of manufacturing teams and issues around cost optimization.