{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["22"],"submitter":["Pasqua S"],"pubmed_abstract":["Endotoxin content is a critical factor that affects the safety of biological pharmaceutical products. International pharmacopoeias describe several reference methods to determine endotoxin levels in advanced therapy medicinal product (ATMP) preparations. Administration of ATMPs must be done as rapidly as possible to ensure complete viability and potency of the cellular product. To evaluate the endotoxin content in the shortest time possible, we chose to validate an alternative method based on the use of the Charles River Portable Testing System (PTS) and FDA-approved cartridges, compliant with the requirements of the European Pharmacopoeia and providing results in <20 min. Here, we describe a unique and complete validation approach for instrument, personnel, and analytical method for asses"],"journal":["Molecular therapy. Methods & clinical development"],"pagination":["320-329"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC8408548"],"repository":["biostudies-literature"],"pubmed_title":["Complete intra-laboratory validation of a LAL assay for bacterial endotoxin determination in EBV-specific cytotoxic T lymphocytes."],"pmcid":["PMC8408548"],"pubmed_authors":["Di Bartolo C","Miele M","Di Bella M","Niotta MC","Timoneri F","Di Martino G","Pasqua S","D'Apolito D","Conaldi PG","Sottile D","Douradinha B","Cuscino N"],"additional_accession":[]},"is_claimable":false,"name":"Complete intra-laboratory validation of a LAL assay for bacterial endotoxin determination in EBV-specific cytotoxic T lymphocytes.","description":"Endotoxin content is a critical factor that affects the safety of biological pharmaceutical products. International pharmacopoeias describe several reference methods to determine endotoxin levels in advanced therapy medicinal product (ATMP) preparations. Administration of ATMPs must be done as rapidly as possible to ensure complete viability and potency of the cellular product. To evaluate the endotoxin content in the shortest time possible, we chose to validate an alternative method based on the use of the Charles River Portable Testing System (PTS) and FDA-approved cartridges, compliant with the requirements of the European Pharmacopoeia and providing results in <20 min. Here, we describe a unique and complete validation approach for instrument, personnel, and analytical method for asses","dates":{"release":"2021-01-01T00:00:00Z","publication":"2021 Sep","modification":"2025-04-22T21:25:49.036Z","creation":"2022-02-11T13:25:45.722Z"},"accession":"S-EPMC8408548","cross_references":{"pubmed":["34514024"],"doi":["10.1016/j.omtm.2021.05.002"]}}