{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Sutherland V"],"funding":["NIDCR NIH HHS","NCI NIH HHS","National Institutes of Health"],"pagination":["32-36"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC8368080"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["24(1)"],"pubmed_abstract":["Immunotherapy of cancer and other diseases is often dependent on adoptive transfer to patients of cellular products generated in Current Good Manufacturing Practice (cGMP) facilities. With the availability and approval of various cellular products for therapy, cell production facilities are experiencing unprecedented growth in demand for services. Increasingly, these services involve processing of externally generated cells for transfer to the bedside. The arrival of cells from external manufacturing facilities for processing and eventual infusion of cell therapy products into patients creates a new layer of responsibility and adds to an already demanding list of the existing procedures in academic cGMP facilities. Sponsors introduce their own requirements for the handling of cells that th"],"journal":["Cytotherapy"],"pubmed_title":["Impact of contracted manufacturing organization protocols on operations in an aca demically based Current Good Manufacturing Practice facility."],"pmcid":["PMC8368080"],"funding_grant_id":["P30 CA047904","U01 DE029759"],"pubmed_authors":["Sutherland V","Whiteside TL","Buffo MJ"],"additional_accession":[]},"is_claimable":false,"name":"Impact of contracted manufacturing organization protocols on operations in an aca demically based Current Good Manufacturing Practice facility.","description":"Immunotherapy of cancer and other diseases is often dependent on adoptive transfer to patients of cellular products generated in Current Good Manufacturing Practice (cGMP) facilities. With the availability and approval of various cellular products for therapy, cell production facilities are experiencing unprecedented growth in demand for services. Increasingly, these services involve processing of externally generated cells for transfer to the bedside. The arrival of cells from external manufacturing facilities for processing and eventual infusion of cell therapy products into patients creates a new layer of responsibility and adds to an already demanding list of the existing procedures in academic cGMP facilities. Sponsors introduce their own requirements for the handling of cells that th","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Jan","modification":"2025-04-04T01:24:02.675Z","creation":"2025-04-04T01:24:02.675Z"},"accession":"S-EPMC8368080","cross_references":{"pubmed":["33610480"],"doi":["10.1016/j.jcyt.2020.12.015"]}}