Variations in novel cellular therapy products manufacturing |
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| Affiliation: | 1. University of Maryland School of Medicine, Baltimore, Maryland, USA;2. Biomedical Excellence for Safer Transfusion (BEST);3. Center for Cellular Engineering, Department of Transfusion Medicine, Clinical Center, National Institutes of Health, Bethesda, Maryland, USA;4. Molecular and Cellular Therapeutics, University of Minnesota, Saint Paul, Minnesota, USA;5. Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA;6. Japanese Red Cross Society Blood Service Headquarters, Tokyo, Japan;7. Institut für Klinische Transfusionsmedizin, Städtisches Klinikum Braunschweig gGmbH, Braunschweig, Germany;8. NHS Blood and Transplant, The John Radcliffe Hospital, Oxford, UK;9. University of Utah, Salt Lake City, Utah, USA;1. Department of Joint Surgery, Hong Hui Hospital, Xi''an Jiaotong University, Xi''an, China;2. Department of Geriatrics, Xijing Hospital, the Fourth Military Medical University, Xi''an, China;3. Department of Anesthesiology, the Second Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine, Xianyang Shaanxi, China;4. Translational Medicine Center, Hong Hui Hospital, Xi''an Jiaotong University, Xi''an, China;5. Department of Spine Surgery, Hong Hui Hospital, Xi''an Jiaotong University, Xi''an, China;1. Seta Clinic Group, Tokyo, Japan;2. Department of Next-Generation Cell and Immune Therapy, Juntendo University School of Medicine, Tokyo, Japan;3. Kanazawa Advanced Medical Center, Kanazawa, Japan;4. Department of Gastroenterology, Graduate School of Medicine, Kanazawa University, Kanazawa, Japan |
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| Abstract: | Background aimsAt the frontier of transfusion medicine and transplantation, the field of cellular therapy is emerging. Most novel cellular therapy products are produced under investigational protocols with no clear standardization across cell processing centers. Thus, the purpose of this study was to uncover any variations in manufacturing practices for similar cellular therapy products across different cell processing laboratories worldwide.MethodsAn exploratory survey that was designed to identify variations in manufacturing practices in novel cellular therapy products was sent to cell processing laboratory directors worldwide. The questionnaire focused on the manufacturing life cycle of different cell therapies (i.e., collection, purification, in vitro expansion, freezing and storage, and thawing and washing), as well as the level of regulations followed to process each product type.ResultsThe majority of the centers processed hematopoietic progenitor cells (HPCs) from peripheral blood (n = 18), bone marrow (n = 16) or cord blood (n = 19), making HPCs the most commonly processed cells. The next most commonly produced cellular therapies were lymphocytes (n = 19) followed by mesenchymal stromal cells (n = 14), dendritic cells (n = 9) and natural killer (NK) cells (n = 9). A minority of centers (<5) processed pancreatic islet cells (n = 4), neural cells (n = 3) and induced-pluripotent stem cells (n = 3). Thirty-two laboratories processed products under an investigational status, for either phase I/II (n = 27) or phase III (n = 17) clinical trials. If purification methods were used, these varied for the type of product processed and by institution. Environmental monitoring methods also varied by product type and institution.ConclusionThis exploratory survey shows a wide variation in cellular therapy manufacturing practices across different cell processing laboratories. A better understanding of the effect of these variations on the quality of these cell-based therapies will be important to assess for further process evaluation and development. |
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