Release Testing

Streamlining Release Testing for Quality Control in Autologous CAR-T Cell Therapy

Before the release of CAR-T batches to the clinic for patient infusion, product QC and release testing must be conducted. Identity, potency, purity, dose and safety are all assessed and documented before release. Assays requiring imaging readouts, like sterility, microbial contamination or endotoxin testing can be measured on a Molecular Devices SpectraMax Multi-mode Reader with Softmax Pro GxP software. Identity can be confirmed using flow cytometry-based assays and prepared on a Beckman Coulter Life Sciences Biomek i-Series Automated Workstation that supports 21 CFR Part 11 and run on a Beckman Coulter Life Sciences CytoFLEX Flow Cytometer with Kaluza C analysis software. Viability can be measured on a Beckman Coulter Life Sciences Vi-CELL BLU Cell Viability Analyzer. Genetic stability tests requiring sample preparation on a liquid handler can leverage the Beckman Coulter Life Sciences Biomek i-Series Automated Workstation that supports 21 CFR Part 11.

To enhance GMP manufacturing, the IDBS Skyland PIMS platform can be used for a 21 CFR Part 11 compliant digital backbone and end-to-end analytics workspace. By doing so, it is possible to seamlessly combine product and process data, resulting in reduced production costs, fewer batch failures and easier regulatory reporting. In GMP-compliant environments, monitoring can be performed with a Beckman Coulter Life Sciences MET ONE 3400+ Series Portable Airborne Particle Counter and Beckman Coulter Life Sciences PAT700 Total Organic Carbon Analyzer.

To support release testing workflows, the Genedata Biopharma Platform streamlines and automates data capture, analysis and management. It integrates identity, purity, potency and safety assay results, supports genetic stability and biosafety assessments, and generates GMP-compliant batch release documentation to ensure product quality and regulatory readiness.