By AABB (Advancing Transfusion and Cellular Therapies Worldwide), Ellen M. Areman, SBB(ASCP), Kathy Loper, MHS, MT(ASCP)
This manual was designed as a compendium of state-of-the-art practices and methods for developing and producing cellular therapy products, and for development and operation of a cellular therapy facility, whether for research, translational or clinical. Applicable to academia, government and industry, it is also an essential reference for those in regulatory affairs and quality assurance as well as for laboratory technologists, managers, directors, physicians and scientists. Through descriptions of the rationale and methodology for a variety of cell processing and evaluation techniques, it will assist laboratory staff in developing procedures that comply with applicable regulations and standards. In addition to numerous examples and templates for laboratory document preparation, several methods are provided that include a general overview of the critical steps, materials and equipment used in each process. Each section has been compiled and edited by a team of experts in the field, with subchapters contributed by specialists in the specific subject matter. As regenerative medicine becomes more integrated into the field, considerations for regenerative therapies are also integrated within each section.Chapters cover:Regulatory considerations: Including updated FDA tips and perspectives, IND and BLA processes, sample outlines, etc. New in this edition: International regulation of cell therapy products.Quality assurance: Including process control, records, audits, equipment, personnel, validation, etc.Facilities: Aseptic processing, computer systems, safety and procedures for facility control.Product and Process development: New in this edition: Pre-clinical testing and early phase trial development.Collection of Cells: Marrow, apheresis and cord blood techniques.Manufacturing Methods: In this edition: 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: Including shipping and handling; product release; patient preparation, infusion, and reactions; etc.New in this edition: Biorepositories: Including operational, regulatory and ethical considerations for storage of research samples. Product characterization: Including assessments of viability, potency, cytotoxicity, contamination, testing, etc., as well as validation of test methods.
