title: Production of stem-cell transplants according to good manufacturing practice.
abstract: Peripheral blood stem cells (PBSCs) are used for transplantation to reconstitute the hematopoietic system after high-dose chemotherapy. They are harvested from peripheral blood after mobilization by cytokines and/or chemotherapy. 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 and the total number is steadily increasing [1]. To ensure quality and safety of the final cell products intended for clinical use, national and international guidelines and regulations have been issued. The implementation of a quality assurance (QA) program including the principles of good manufacturing practice (GMP) and a quality control system is a major requirement. GMP regulations apply to all phases of cell collection, processing, and storage, and to documentation, training of personnel, and equipment of the cell processing laboratory. They have to be followed by pharmaceutical companies and medical doctors who are involved in PBSC processing at academic institutions. The complicated regulatory network for the manufacturing of cell products will help to standardize these procedures and ensure consistent quality and safety in the long term. This will be in the interest of patients and reduce risks of application of individual cell preparations.
authors.affiliation: CellGenix Technologie Transfer GmbH, Freiburg, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Bosse
authors.forename: P
authors.initials: P
authors.lastname: Kulmburg
authors.forename: C
authors.initials: C
authors.lastname: von Kalle
authors.forename: M
authors.initials: M
authors.lastname: Engelhardt
authors.forename: A
authors.initials: A
authors.lastname: Dwenger
authors.forename: F
authors.initials: F
authors.lastname: Rosenthal
authors.forename: G
authors.initials: G
authors.lastname: Schulz
mesh_terms: D019411:Clinical Laboratory Techniques / Q000592:standards*; D005858:Germany; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D007883:Legislation, Medical; D011786:Quality Control; D014481:United States