Biopharmaceutical Manufacturing: Regulatory Processes (Volume 1) (Iop eBooks)

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 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 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 optimisation

Sunitha Lokesh is the director of biomanufacturing operations at Pharmaceutical Scientist Inc., where she leads the identification and technology development of biopharmaceutical products. She has over 10 years of experience in developing biopharmaceuticals, from the cell line to process validation.