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 checkpoints
Automation: Streamline CAR-T production with integrated DCU for real-time monitoring of cell growth throughout expansion with substrate addition via multiple controllers
Remote manufacturing: Gain real-time process insight for possible manufacturing trajectory correction with Sartorius multivariate prediction technology
Assured 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
Control Strategy
Biostat® RM
Automated, fully GMP-compliant, wave-mixed bioreactor for CAR-T cell expansion with fed-batch, perfusion or a combination
Flexsafe® RM
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
Ksep® Centrifugation System
Automated, single-use, closed-system centrifugation system with low-shear, gentle, harvesting for reliable, safe and robust downstream processing of allogeneic CAR-T therapies
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
Automated, fully GMP-compliant, wave-mixed bioreactor for CAR-T cell expansion with fed-batch, perfusion or a combination
Remote Manufacturing
SIMCA®-online
Multivariate prediction technology for actionable insights into manufacturing trajectory correction to achieve consistent MSC cell quality
Assured Supply
Flexsafe® RM
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
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
