Production of stem-cell transplants according to good manufacturing practice

Peripheral blood stem cells (PBSCs) are used for transplantation to reconst itute the hematoporetic system after high-dose chemotherapy. They are harve sted from peripheral blood after mobilization by cytokines and/or chemother apy. Further ex vivo manipulation steps (e.g., selection of CD34(+) PBSCs, purging, expansion, and differentiation or gene transfer) can be performed. In 1997, more than 12,000 PBSC preparations were transplanted in Europe an d the total number is steadily increasing [1]. To ensure quality and safety of the final cell products intended for clinical use, national and interna tional guidelines and regulations have been issued. The implementation of a quality assurance (QA) program including the principles of good manufactur ing practice (GMP) and a quality control system is a major requirement. GMP regulations apply to all phases of cell collection, processing, and storag e, and to documentation, training of personnel, and equipment of the cell p rocessing laboratory. They have to be followed by pharmaceutical companies and medical doctors who are involved in PBSC processing at academic institu tions. The complicated regulatory net work for the manufacturing of cell pr oducts will help to standardize these procedures and ensure consistent qual ity and safety in the long term. This will be in the interest of patients a nd reduce risks of application of individual cell preparations.