Rapid Growth-Based Sterility Results in Hours, Not Weeks
Time: 11:45 am
day: Track B - Immunophenotype Assay (Day Two - Morning)
Details:
- Rapid sterility testing of cell and gene therapies (CGTs), using activated pan T-cells spiked with organisms with accurate results within 48 hours, improving batch release and patient safety.
- Mango technology detected colonies for six of seven organisms in under eight hours and identified Cutibacterium acnes within 30–40 hours—significantly faster than traditional methods. Its CFU counts were comparable to the compendial spread plate method.
- The Mango platform demonstrated potential as a rapid, accurate sterility test for CGTs, achieving results within 48 hours while maintaining precision.
