Optimizing Automated Growth-Based Methods for Faster Sterility Release Testing of Cell & Gene Therapy Products

Automated Growth-based methods are used for rapid detection of microbial contamination in pharmaceutical products such as Cell and gene therapy (CGT). For therapies on the critical path to patient treatment, every day/hour gained on release testing is crucial to accelerate delivery to patients in need.

The BACT/ ALERT® 3D (BTA) Solution provides an automated non-destructive growth-based rapid microbial method and is considered a reference method by both European Pharmacopeia (EP) chapter 2.6.27 and United States (USP) chapter <72>. Although most relevant microorganisms are detected in less than 72h, the current practice is the release of product after 7 days incubation, mainly due to the risk of contamination with ‘slow growing’ microorganisms such as molds, Cutibacterium acnes or Micrococcus luteus. To improve the detection of such microorganisms, different culture media, growth factors and incubation conditions were evaluated. Applying USP <72> guidelines, the minimum incubation time was determined and compared to current practices..

PURPOSE OF THIS WORK

Present data demonstrating how optimizing incubation conditions and supplementing BACT/ALERT® media can significantly improve time to detection, in alignment with the new USP <72> chapter, thereby reducing detection of microbial contamination timelines and accelerating CGT product release.