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
 

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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

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

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

Sartorius T-Cell Pilot Solution Data Sheet Collection

T-Cell-Pilot-Solution-Sartorius.pdf

PDF | 13.6 MB

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