US Approval of Three Rapid Microbiological Methods for MACI Product Release
Rapid detection of contaminants, especially those affecting critical quality attributes, is essential for cell therapy products with short shelf lives. Integrating quality into the process through lot segregation, raw material qualification, environmental control, personnel training, and detailed procedures is critical because final results for conventional microbiological tests may not be available prior to product release or patient administration.US FDA approval of the MACI BLA in 2016 included three RMM product release assays for sterility, endotoxin, and mycoplasma.
John Duguid -
Senior Director, Research & Development,
Michael Brewer -
Director, Head of Pharma Analytics,
Thermo Fisher Scientific