Sartorius T-Cell Autologous Manufacturing Solution

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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 testing
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
 

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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

SIMCA®-online

Multivariate prediction technology for actionable insights into manufacturing trajectory correction to achieve consistent MSC cell quality

Process Insight

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

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

Sartorius T-Cell Autologous Manufacturing Solution Data Sheet...

T-Cell-Autologous-Manufacturing-Solution-Sartorius.pdf

PDF | 11.1 MB

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