Introduction: During changeover in cell-product processing, it is essential to minimize cross-contamination risks. These risks differ depending on the patient from whom the cells were derived. Human error during manual cell-product processing increases the contamination risk in biosafety cabinets. Here, we evaluate the risk of cross-contamination during manual cell-processing to develop an evidence-based changeover method for biosafety cabinets.
Methods: Contaminant coverage was analyzed during simulated medium preparation, cell seeding, and waste liquid decanting by seven operators, classified by skill. Environmental bacteria were surveyed at four participating facilities. Finally, we assessed the effect of conventional UV irradiation in biosafety cabinets on bacteria and fungi that pose a cross-contamination risk.
Results: Under simulated conditions, scattered contamination occurred via droplets falling onto the surface from heights of 30 cm, and from bubbles rupturing at this height. Visible traces of contaminants were distributed up to 50 cm from the point of droplet impact, or from the location of the pipette tip when the bubble ruptured. In several facilities, we detected , of which the associated endospores are highly resistant to disinfection. Irradiation at 50 mJ/cm effectively eliminated vegetative cells and , which is highly resistant to UV. endospores were eliminated at 100 mJ/cm.
Conclusions: Under these simulated optimal conditions, UV irradiation successfully prevents cross-contamination. Therefore, following cell-product processing, monitoring the UV dose in the biosafety cabinet during cell changeover represents a promising method for reducing cross-contamination.
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http://dx.doi.org/10.1016/j.reth.2022.12.003 | DOI Listing |
Front Immunol
December 2024
Research and Development, Miltenyi Biotec, Bergisch Gladbach, Germany.
Recent studies have revealed the potential of tumor-infiltrating lymphocytes (TILs) to treat solid tumors effectively and safely. However, the translation of TIL therapy for patients is still hampered by non-standardized and laborious manufacturing procedures that are expensive and produce highly variable cellular products. To address these limitations, the CliniMACS Prodigy Tumor Reactive T cell (TRT) Process has been developed.
View Article and Find Full Text PDFRegen Ther
March 2025
Center for Stem Cell and Regenerative Medicine, Institute of Science Tokyo, 1-5-45, Bunkyo-ku, Yushima, Tokyo 113-8519, Japan.
Introduction: Cell-processing operations can potentially contaminate biosafety cabinets, which should be maintained sterile. However, unintended contamination can occur owing to the presence of viruses, mycoplasmas, and bacteria in the raw materials. Moreover, although several methods for expunging these contaminants have been proposed, an optimal method has not yet been determined.
View Article and Find Full Text PDFCell Syst
December 2024
George W. Woodruff School of Mechanical Engineering, Georgia Institute of Technology, Atlanta, GA 30332, USA; Parker H. Petit Institute for Bioengineering and Bioscience, Georgia Institute of Technology, Atlanta, GA 30332, USA; Wallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology and Emory University, Atlanta, GA 30332, USA; Winship Cancer Institute, Emory University, Atlanta, GA 30322, USA. Electronic address:
Established and emergent microengineered in vitro systems enable the evaluation of chimeric antigen receptor (CAR) T cell product purity, avidity, and functionality. Here, we describe such systems and how they have been used to optimize CAR T cell products by selecting highly viable cells, eliminating off-target cells, and tailoring avidity to balance efficacy and safety. The future of CAR T cell therapy development and manufacturing is expected to be anchored in a cyclical process that integrates multiple high-throughput and patient-centered techniques for identifying, enriching, and evaluating T cell subtypes.
View Article and Find Full Text PDFTransfusion
December 2024
Dipartimento di Scienze di Laboratorio ed Ematologiche, Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy.
Background: Extracorporeal photopheresis (ECP) has been demonstrated as an effective treatment for graft-versus-host disease (GvHD). The inline system was developed by Therakos in 1987. Recently, Fresenius Kabi implemented an integration of cell separator Amicus and a UVA photoactivation device (Phelix), realizing an inline photopheresis system.
View Article and Find Full Text PDFJ Clin Apher
December 2024
Division of Transfusion Medicine, Department of Pathology, City of Hope National Medical Center, Duarte, California, USA.
The majority of the time hematopoietic progenitor cells (HPC) are collected through leukapheresis, where anticoagulants are necessary to prevent clotting of the apheresis circuit and HPC product. Although clotting of the product is a possible rare complication surrounding the HPC cryopreservation process, there have been no reports of clotting of fresh HPC product after collection. We report a case of progressive clotting of a fresh matched unrelated donor HPC product.
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