Harvest, Fill & Finish

Autologous CAR-T Cell Harvest, Fill & Finish Solutions

Once CAR-T cells have been expanded to desired quantities and passed necessary quality control tests, the Beckman Coulter Life Sciences Avanti JXN-26 Series High-Performance Centrifuges can help during harvesting and come with enhanced data management, which can support GMP processes. Track final cell counts and viability using a Beckman Coulter Life Sciences Vi-CELL BLU Cell Viability Analyzer.

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 CounterandBeckman Coulter Life Sciences PAT700 Total Organic Carbon Analyzer

To ensure a smooth transition from production to release, the Genedata Biopharma Platform streamlines and automates data capture, analysis and management. It tracks final cell product characteristics, integrates in-process control data and generates GMP-compliant batch documentation to support product handoff and manufacturing traceability.