Advancing Transfusion and Cellular Therapies Worldwide: A Comprehensive Guide

This authoritative manual, designed by AABB (Advancing Transfusion and Cellular Therapies Worldwide), is an indispensable resource for professionals involved in developing and producing cellular therapy products. Compiled by experts in the field, it provides a state-of-the-art overview of methods and practices for establishing and operating cellular therapy facilities, whether for research, translational, or clinical purposes.

As a valuable reference, this manual caters to academia, government, and industry professionals, including those in regulatory affairs, quality assurance, laboratory technologists, managers, directors, physicians, and scientists. It offers in-depth descriptions of cell processing and evaluation techniques, empowering laboratory staff to develop procedures that comply with applicable regulations and standards.

The manual is packed with practical tools, including numerous examples and templates for laboratory document preparation. Each section is meticulously crafted by a team of experts, with subchapters contributed by specialists in specific subject matter. The importance of regenerative therapies is acknowledged, and considerations for these therapies are thoughtfully integrated throughout the manual.

Comprehensive Coverage of Key Topics

• Regulatory Considerations: Updated FDA tips and perspectives, IND and BLA processes, sample outlines, and international regulation of cell therapy products.
• Quality Assurance: Process control, records, audits, equipment, personnel, validation, and more.
• Facilities: Aseptic processing, computer systems, safety, and procedures for facility control.
• Product and Process Development: Pre-clinical testing and early phase trial development.
• Collection of Cells: Marrow, apheresis, and cord blood techniques.
• Manufacturing Methods: Updated techniques for cell separation, cell expansion, and graft engineering, including production of dendritic, mesenchymal, pancreatic islet, iPS, and other therapeutic cells.
• Handling of Processed Products: Shipping and handling, product release, patient preparation, infusion, and reactions.
• Biorepositories: Operational, regulatory, and ethical considerations for storage of research samples.
• Product Characterization: Assessments of viability, potency, cytotoxicity, contamination, testing, and validation of test methods.

Publisher: American Association of Blood Banks (AABB)

Edition: 2nd edition, April 13, 2016

Language: English

Pages: 897

ISBN-10: 156395916X

ISBN-13: 978-1563959165