Functionally Closed, Scalable Cell Expansion and Harvest System
The number of autologous and allogeneic CAR-T therapy candidates has been growing rapidly. To enable at-throughput production of CAR-T therapies of consistent quality, there is a growing need for robust protocols that decrease labor input and lower COGs. Most consistent results are obtained by:
- implementing process control through the use of functionally closed-system bioreactors, low E&L consumables, consistent T-cell media, gentle harvesting, and sterility testing;
- acquiring process knowledge through pH, DO, and viable biomass measurements.
Simplification, process control, and quality — a new level of T-cell expansion process development for today’s cutting-edge therapies.
Sartorius CAR T-Cell Expansion Solution
Application Note
CAR-T Expansion Using the Sartorius T-Cell Expansion Solution
Discover our GMP-qualified cell expansion system and consistent, specifically designed and optimized for T-cells medium.
Biostat® RM TX
Rocking motion bioreactor system for ex vivo expansion of high cell density patient T cell cultures with perfusion, fed-batch or both
- Complete qualification of the system for GMP use to support regulatory compliance
- Advanced control and monitoring of gas mixture and flow rate, filling volume and substrate addition; parallel activation of multiple controllers for flexibility
- On-line viable biomass analysis
Flexsafe® RM with BioPAT® Viamass
Single-use, lot-to-lot consistent, E&L-minimized bags (1, 2, or 10 L) with inline single-use cell growth, pH, and DO monitoring
- Single-use sensors for pH, DO, and viable biomass
- Fixed perfusion membrane (PES, 1.2 μm) forms a compartment for removal of cell-free media to minimize cell loss or damage
- 100% integrity-tested, gamma-irradiatable, and fully validated sterile filters
4Cell® Nutri-T
Developed on actual cancer patient cells, this media offers excellent growth results even with low initial seeding densities
- Serum-free and xeno-free
- Excellent performance with low initial seeding densities - no need to add serum
- Research use only
- Excellent performance for CAR-T, PBMC, and TIL
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FlexSafe® RM TX Harvesting Device
Reduced-shear, pump-free gravity harvesting for maximum viability and recovery and minimized contamination risk
Be on the Safe Side
Learn about a 3-hour, PCR-based sterility testing and process control for CAR-T therapies.
Microsart® ATMP
3-hour, GMP-compliant, highly specific and sensitive sterility testing for process control
