Gene Modification and Analysis Solutions for Autologous CAR-T Cell Therapy
T cells are genetically modified to express the CAR (chimeric antigen receptor) construct. While modifying cells, track cell counts and viability using a Beckman Coulter Life Sciences Vi-CELL BLU Cell Viability Analyzer. The Beckman Coulter Life Sciences Multisizer 4e Coulter Size Analyzer can measure cell volume changes pre- and post-modification and supports GMP compliance.
Analyses of CAR-T cells can include functional assays requiring microplate imaging readouts performed 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 functional assays.
NGS library preparation for genomic analyses can be performed on a Beckman Coulter Life Sciences Echo Acoustic Liquid Handler. Flow cytometry-based assays to assess CAR expression 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. Liquid handling during sample preparation for assays to characterize transduction or transfection efficiency and vector copy number can also be conducted on a Beckman Coulter Life Sciences Biomek i-Series Automated Workstation. 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 Counter and Beckman Coulter Life Sciences Anatel PAT700 Total Organic Carbon Analyzer.