Cell Expansion Solutions for Autologous CAR-T Cell Therapy
CAR-T cells are expanded to increase numbers for characterization, formulation and fill-finish steps. While expanding cultures, track cell counts and viability using a Beckman Coulter Life Sciences Vi-CELL BLU Cell Viability Analyzer. Characterize metabolites with a Beckman Coulter Life Sciences Vi-CELL MetaFLEX Bioanalyte Analyzer that can support GMP compliance.
Functional assessment can be performed in parallel to expansion. CAR-T cytokine ELISAs can be measured on a Molecular Devices SpectraMax Multi-mode Reader with Softmax Pro GxP software. The Leica Microsystems STELLARIS Confocal Microscope Platforms enable live cell and time-lapse imaging experiments for cell-killing assays. Flow cytometry-based assays can be 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. Collect and track experiment and instrument data within discovery or development labs with the IDBS Polar Biopharma Lifecycle Management software.
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 Counterand Beckman Coulter Life Sciences Anatel PAT700 Total Organic Carbon Analyzer