Sartorius T-Cell Allogeneic Manufacturing Solution
Functionally closed, scalable solution to produce consistent, high-quality allogeneic CAR-T cells
Control strategy: Monitor processes and enact manufacturing control strategy through advanced, sensitive control, consistent serum-free, xeno-free T-cell medium, single-use fluidized bed counter-flow centrifugation platform, and 3-hour PCR-based sterility checkpointsAutomation: Streamline CAR-T production with integrated DCU for real-time monitoring of cell growth throughout expansion with substrate addition via multiple controllersRemote manufacturing: Gain real-time process insight for possible manufacturing trajectory correction with Sartorius multivariate prediction technologyAssured supply: Maintain consistently high CAR-T cell product quality with low-E&L consumables manufactured under complete control of single-use supply chain and with long-term business continuity
Automated, fully GMP-compliant, wave-mixed bioreactor for CAR-T cell expansion 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
Automated, single-use, closed-system centrifugation system with low-shear, gentle, harvesting for reliable, safe and robust downstream processing of allogeneic CAR-T therapies
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
Multivariate prediction technology for actionable insights into manufacturing trajectory correction to achieve consistent MSC cell quality
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