This new edition presents a fully-updated and expanded look at current Good Manufacturing Practice (cGMP) for cell therapy products. It provides a complete discussion of facility design and operation including details specific to cord blood banking, cell processing, vector production and qualification of a new facility. Several chapters cover facility infrastructure including cleaning and maintenance, vendor qualification, writing a Standard Operating Procedure, staff training, and process validation. The detailed and invaluable product information covers topics like labelling, release and administration, transportation and shipment, et al. Further chapters cover relevant topics like writing and maintaining investigational new drug applications, support opportunities in North America and the European Union, commercial cell processing and quality testing services, and financial considerations for academic GMP facilities. A chapter on future directions rounds out Cell Therapy: cGMP Facilities and Manufacturing making it essential reading for any cell therapy professional involved in the development, use, or management of this type of facility.

Bone Marrow Processing and Purging: A Practical Guide provides an up-to-date practical guide to the major ex vivo procedures associated with bone marrow transplantation. Previously, this information was communicated primarily by word of mouth; now experts in the field present detailed descriptions and evaluations of methods for marrow harvesting, evaluation (including tumor infiltration, flow cytometric analysis, and colony assays), comparative methods for automated nucleated cell separation and enumeration, tumor cell purging, T cell depletion, stem cell selection, gene transfer, and cytopreservation. Special sections address quality control and FDA regulations.
The book provides a unique information source intended for clinicians, researchers, technical staff, transplant nurses, and medical students involved in this rapidly expanding area of medicine.