Essential requirements for setting up a stem cell processing laboratory

• Published in: Bone marrow transplantation (Basingstoke) Vol. 49; no. 8; pp. 1098 - 1105
• Main Authors: Leemhuis, T, Padley, D, Keever-Taylor, C, Niederwieser, D, Teshima, T, Lanza, F, Chabannon, C, Szabolcs, P, Bazarbachi, A, Koh, M B C
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 01-08-2014; Nature Publishing Group
• Subjects: 631/532/1542; 631/61/2320; 692/700/565/545/576/1955; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Biological and medical sciences; Bone marrow; Bone marrow, stem cells transplantation. Graft versus host reaction; Buildings and facilities; Cell Biology; Hematology; Hematopoietic Stem Cell Transplantation; Hematopoietic Stem Cells; Humans; Internal Medicine; Laboratories; Laboratories, Hospital - organization & administration; Laboratories, Hospital - standards; Management; Medical laboratories; Medical Laboratory Personnel - organization & administration; Medical Laboratory Personnel - standards; Medical Laboratory Personnel - supply & distribution; Medical sciences; Medicine; Medicine & Public Health; Physicians; Practice Guidelines as Topic; Public Health; Quality management; Stem cell research; Stem cell transplantation; Stem Cells; technical-report; Technologists; Transfusions. Complications. Transfusion reactions. Cell and gene therapy; Transplantation; Transplants & implants; Hematology; Stem cell; Laboratory
• ISSN: 0268-3369; 1476-5365
• DOI: 10.1038/bmt.2014.104

The Graft Processing subcommittee of the Worldwide Network for Blood and Marrow Transplantation wrote this guideline to assist physicians and laboratory technologists with the setting up of a cell processing laboratory (CPL) to support a hematopoietic stem cell transplant program, thereby facilitating the start-up of a transplant program in a new location and improving patient access to transplantation worldwide. This guideline describes the minimal essential features of designing such a laboratory and provides a list of equipment and supply needs and staffing recommendations. It describes the typical scope of services that a CPL is expected to perform, including product testing services, and discusses the basic principles behind the most frequent procedures. Quality management (QM) principles specific to a CPL are also discussed. References to additional guidance documents that are available worldwide to assist with QM and regulatory compliance are also provided.