Sartorius T-Cell Pilot Solution
Scaled-up, semi-automated expansion and characterization solution to develop process insight through CPP and CQA correlation for a robust CAR-T manufacturing protocol
Process control: Determine optimal growth performance and identify critical process parameters with consistent, serum-free, xeno-free T-cell medium and rapid sterility testing in volumes from 100mL to 250mL
Automation: Rapid process development and process optimization with minimal manual handling and online automated monitoring as well as functional and phenotypic characterization of CAR-T cells
At-scale throughput: Optimize at throughput with 1-8 bioreactors operated in parallel and perform multiplex analysis in 96- and 384-well plates
Extensive characterization: Test CAR-T phenotype and function with multiplex analysis of cells in suspension and profiling in T-cell killing and T-cell health assays
Process insight: Gain rapid understanding of the optimal expansion protocol by analyzing process parameters and characterization data to correlate CPPs and CQAs
Process Control
Biostat® RM TX
Automated control unit and a rocking platform for ex vivo expansion of CAR-T cells with fed-batch, perfusion or a combination
Flexsafe® RM TX
Single-use, low-E&L, gamma-irradiated culture bag with single-use pH, DO and viable biomass sensors and seamless connection to up-and downstream processes
4Cell® Nutri-T
Xeno-free, serum-free medium specifically designed for the culture and expansion of lymphocytes
Flexsafe® RM TX Harvest Device
Hands-free gravity harvest of CAR-T cells with maximum recovery, cell integrity, and cell viability
Microsart® ATMP
3-hr PCR-based kit for the detection of mycoplasma, bacteria, and fungi for in-process and rapid release testing of cell-based therapeutics
Flexsafe® 2D
Single-use, low-E&L bags of superior strength and flexibility that meet the highest business continuity requirements and serve media and buffer storage and mixing needs
Biowelder® TC
Fully automated welder for sterile connection of dry or liquid-filled thermoplastic tubing to enable sterile, closed-system processing of CAR-T cell products
Biosealer® TC
Fully automated sterile disconnection device to produce permanent and consistent leak-free seals and enable sterile, closed-system processing of CAR-T cell products
Automation
Biostat® RM TX
Automated control unit and a rocking platform for ex vivo expansion of CAR-T cells with fed-batch, perfusion or a combination
Incucyte® SX5
Automated, real-time, quantitative, live-cell imaging and analysis platform for T-cell homing (chemotaxis), activation and function assays
iQue® 3
High-throughput, advanced flow cytometry platform for T-cell activation and cytokine profiling assays as well as multiplexed phenotypic analysis
Extensive Characterization
Incucyte® SX5
Automated, real-time, quantitative, live-cell imaging and analysis platform for T-cell homing (chemotaxis), activation and function assays
iQue® 3
High-throughput, advanced flow cytometry platform for T-cell activation and cytokine profiling assays as well as multiplexed phenotypic analysis
Process Insight
Powerful multivariate data analysis tool with interactive visualizations, an intuitive interface, and automatable workflows
