Microbiological Contamination in Cell Therapy Manufacturing

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Microbiological Contamination in Cell Therapy Manufacturing


Cell therapy manufacturing is an area of interest for both the CAACB and BioMAN consortia, where we have often discussed the need for rapid microbiological detection methods. This is also a focus in our sponsored research activities, particularly through the Singapore-MIT Alliance for Research and Technology’s program on Critical Analytics for Manufacturing Personalized-Medicine (SMART CAMP). 

Through our work, we have identified the need for a comprehensive collection of information about microbiological contamination events experienced in cell therapy manufacturing (e.g. CAR-Ts, MSCs, and others), including academic and hospital laboratories as well as industrial facilities. This information would be valuable for assessing the risk in cell therapy manufacturing as well as for developing suitable detection methods. Our experience in the CAACB has shown this to be the case. 

The Biomanufacturing@MIT-CBI and SMART CAMP team has prepared a questionnaire about microbiological contamination events in cell therapy manufacturing which we will be using to collect this information. We will be following the CAACB model of anonymizing data and publishing our findings to serve as a useful resource for the wider ATMP manufacturing community. 


Dr. Paul W. Barone
(Center for Biomedical Innovation)

Dr. Cheryl Chan

Dr. Jessica McGrath
(Center for Biomedical Innovation

Dr. Stacy L. Springs
(Center for Biomedical Innovation)

Dr. Jackie Wolfrum
(Center for Biomedical Innovation

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