Journal of pharmaceutical and biomedical analysisDrug ContaminationReproducibility of ResultsRinger's LactateHumansSuspensions
Validation of the Bactec system for sterility testing of advanced therapy medicinal product suspensions in Ringer's Lactate.
Ilona Szabłowska-Gadomska, Marta Bochyńska-Czyż, Agnieszka Mroczko
Published: 202610.1016/j.jpba.2025.117283
Abstract
Ensuring sterility is a key quality requirement in the manufacturing of cell-based medicinal products. This study evaluated the capability of the BACTEC automated microbial detection system to identify viable microorganisms in adipose-derived stem ce…
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