CAR-T Process Development: Expansion

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.

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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

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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

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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

cell based therapies: be on the safe side

Be on the Safe Side

Learn about a 3-hour, PCR-based sterility testing and process control for CAR-T therapies.

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Microsart® ATMP

3-hour, GMP-compliant, highly specific and sensitive sterility testing for process control

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CAR-T Process Development Resources


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