Addressing Product Release Challenges in Cell & Gene Therapies Through Rapid Microbiological Methods
bioMérieux has expanded its molecular diagnostics portfolio with BIOFIRE® SPOTFIRE®, a new generation platform for the pharmaceutical industry. The information and results presented on this page were generated using BIOFIRE® FILMARRAY® and remain relevant for the intended use of BIOFIRE® SPOTFIRE®.
Autologous Cell and Gene Therapies (C>) are increasingly being developed through accelerated manufacturing platforms and as fresh, non-cryopreserved products, placing growing pressure on vein-to-vein timelines. These advances challenge conventional microbiological Quality Control (QC) approaches, as compendial sterility and mycoplasma tests remain poorly aligned with the rapid release needs of these therapies. Rapid Microbiological Methods (RMMs) therefore represent a key enabler, offering faster results while supporting robust, GMP-compliant quality and patient safety.
This poster, co-developed by bioMérieux and CellforCure, demonstrates that RMMs offer significant advantages, including faster detection of contamination, improved sensitivity and specificity, automation, and enhanced data management.
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