G-Rex bioreactors incubated in Heracell™ Vios™ CR CO₂ Incubators help prevent cross contamination and bacterial contamination in cell and gene modified cell therapy production

Abstract: for cell and gene modified cell therapy (GMCT) manufacturing, a robust contamination control strategy (CCS) is necessary to ensure compliance with current good manufacturing practices (cGMP). A successful CCS helps ensure safety, purity, efficacy, and quality of a cell therapy product. Cell therapy manufacturers should implement closed systems (CS) wherever possible and employ equipment that maintains a stable, clean environment with advanced monitoring. We show that CS G-Rex® bioreactors combined with Thermo Scientific™ Heracell™ Vios™ CR carbon dioxide (CO₂) incubators enable simplified parallel processing capabilities and significantly reduced contamination risks in a highly efficient production. Producing T cells, NK cells and others in a CS G-Rex bioreactor (Wilson Wolf Manufacturing, LLC) reduces the risk of contamination. The G-Rex approach eliminates most manual handling, a leading source of contamination. G-Rex bioreactors include weldable tubing for simple CS sterile connections and do not require interventions for feeding. Importantly, CS G-Rex bioreactors feature a validated sterile fluid path that reliably maintains integrity throughout manufacturing as shown by microbial ingress testing based on ASTM E-3251. The bioreactors withstand full immersion in a challenge media solution containing bacteria for at least 14 days. G-Rex bioreactors also passed Viral Penetration testing based on ASTM Method F1671, demonstrating suitability for use in CAR-T and other CGT applications requiring use of virus. Heracell Vios CR CO₂ Incubators provide recovery of all parameters in 10 minutes or less, and uniformity of ±0.3 ˚C per DIN 12880, which defines how incubators and other laboratory heating equipment should be measured. These parameters are maintained even when performing high volume production with ten G-Rex 500M-CS bioreactors simultaneously. Thermo Scientific™ CultiMaxx™ shelving maximizes production capacity per footprint. Incubating multiple G-Rex bioreactors in a single chamber means the incubator must offer proven contamination control features, to protect individual donor/patient product, if applicable. An on-demand cycle delivers 12-log sterility assurance level (SAL). In-chamber HEPA filtration generates air cleanliness in the chamber equal to ISO Class 5. Data show the Heracell Vios CR CO₂ incubators are certified for use in ISO Class 5, GMP Grade A/B cleanrooms. Together, G-Rex bioreactors incubated in Heracell Vios CR CO₂  incubators offer a high yield, parallel processing method with reduced contamination risk in a highly efficient footprint enabling robust CCS in a cGMP environment.

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