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 250mLAutomation: Rapid process development and process optimization with minimal manual handling and online automated monitoring as well as functional and phenotypic characterization of CAR-T cellsAt-scale throughput: Optimize at throughput with 1-8 bioreactors operated in parallel and perform multiplex analysis in 96- and 384-well platesExtensive 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
Automated control unit and a rocking platform for ex vivo expansion of CAR-T cells with fed-batch, perfusion or a combination
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
Xeno-free, serum-free medium specifically designed for the culture and expansion of lymphocytes
Hands-free gravity harvest of CAR-T cells with maximum recovery, cell integrity, and cell viability
3-hr PCR-based kit for the detection of mycoplasma, bacteria, and fungi for in-process and rapid release testing of cell-based therapeutics
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
Fully automated welder for sterile connection of dry or liquid-filled thermoplastic tubing to enable sterile, closed-system processing of CAR-T cell products
Fully automated sterile disconnection device to produce permanent and consistent leak-free seals and enable sterile, closed-system processing of CAR-T cell products
Automated, real-time, quantitative, live-cell imaging and analysis platform for T-cell homing (chemotaxis), activation and function assays
High-throughput, advanced flow cytometry platform for T-cell activation and cytokine profiling assays as well as multiplexed phenotypic analysis
Powerful multivariate data analysis tool with interactive visualizations, an intuitive interface, and automatable workflows
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