This book provides a comprehensive guide to the design and operation of cGMP facilities for cell therapy manufacturing. It addresses practical day-to-day activities such as staff training, cleaning procedures, and environmental monitoring, alongside detailed reviews of quality systems, regulatory frameworks, and professional standards. The text aims to serve as a thorough, facility-focused resource for cell therapy professionals. It covers essential topics including standard operating procedures, supply management, facility equipment, product manufacturing, review, release, administration, and facility master files.

The book is positioned as a crucial resource for cell therapy professionals, meeting a previously unmet need for a dedicated facility-focused guide. Its detailed coverage of cGMP operations, regulatory standards, and practical day-to-day activities suggests it is intended for practitioners and those involved in the quality and compliance aspects of cell therapy manufacturing. The comprehensive nature of the topics covered indicates a valuable reference for establishing and maintaining compliant and efficient cell therapy production environments.