Cellular Therapy: Principles, Methods, and Regulations, 2nd edition (Original PDF from Publisher)

Cellular Therapy Products Manual

by AABB (Advancing Transfusion and Cellular Therapies Worldwide), Ellen M. Areman, SBB(ASCP), Kathy Loper, MHS, MT(ASCP)

Unlock the latest practices in cellular therapy with this comprehensive manual, a vital resource for developing and producing cellular therapy products and managing cutting-edge facilities. Designed for academia, government, and industry professionals, this guide supports laboratory technologists, managers, directors, physicians, scientists, and those in regulatory affairs and quality assurance.

This authoritative text details state-of-the-art cell processing and evaluation techniques, offering practical methodologies, templates, and examples to ensure compliance with regulations and standards. It covers regulatory considerations, including FDA insights, IND/BLA processes, and new international regulations. Key topics include quality assurance, facility management, preclinical testing, cell collection (marrow, apheresis, cord blood), advanced manufacturing methods (cell separation, expansion, graft engineering), and product handling. New additions explore biorepositories, regenerative therapies, and product characterization, including viability, potency, and cytotoxicity assessments.

Key Features

• Updated techniques for cell therapy production and facility operations
• New sections on international regulations, biorepositories, and preclinical testing
• Comprehensive guidance on quality assurance, regulatory compliance, and product characterization
• Practical templates and examples for laboratory documentation