Sartorius T-Cell Autologous Manufacturing Solution
Functionally closed solution to manufacture and rapidly release consistent, high-quality autologous CAR-T cells
Control strategy: Develop and enact a manufacturing control strategy with advanced, sensitive expansion monitoring and control, consistent serum-free, xeno-free T-cell medium, gentle harvesting, and 3-hour PCR-based sterility testingAutomation: 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 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
Multivariate prediction technology for actionable insights into manufacturing trajectory correction to achieve consistent MSC cell quality
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