Sartorius Biostat® RM TX & Flexsafe® RM TX Bags

The Biostat® RM TX and Flexsafe® RM TX bags are specialized versions of the rocking-motion system, specifically engineered for the rigorous demands of Cell and Gene Therapy (CGT). While the standard RM system is a general-purpose lab tool, the "TX" (Therapy) designation indicates a system optimized for clinical manufacturing, focusing on closed-system safety, process automation, and regulatory compliance.

 

Applications

Regenerative Medicine

Regenerative Medicine therapeutics repair, replace and engineer human cells, tissues and organs to restore their normal function. The discipline has great potential to address clinical needs that are currently unmet by conventional pharma or biopharmaceutical products. Rocking motion bioreactors are widely used for the expansion step during stem and T-cell cultivation processes, incl. CAR-T. Companies are actively approaching us to work on the integration of our rocking motion bioreactors into their process environment and explore the PAT capabilities coming with our single-use systems. Tests that these customers perform with Flexsafe® RM bags continue to be successful, even for the most sensitive cells.   

 

Biostat® RM TX

The RM TX is a dedicated rocking controller designed to minimize manual intervention and human error during the production of sensitive patient-specific therapies.

• Automated Process Control: It features a specialized software interface that automates complex tasks like gravity-based harvesting and perfusion, which are common in T-cell and NK-cell workflows.

• Integrated Safety: The rocking platform includes safety interlocks and sensors to detect bag placement and ensure the rocking motion remains within calibrated limits for patient-scale batches.

• Compact Footprint: Designed to fit easily into cleanrooms or laminar flow hoods, where space is a premium in clinical manufacturing suites.

• Connectivity: Fully compatible with BioPAT® MFCS for data logging and batch reporting, providing the audit trails required for 21 CFR Part 11 and Eudralex Volume 4 Annex 11.

Flexsafe® RM TX

The Flexsafe® RM TX bags are the single-use bioreactors tailored for "Scale-Out" manufacturing (processing many individual patient batches simultaneously).

• Closed-System Architecture: All tubing is designed for sterile welding and sealing. The TX bags often feature specific connectors (like MPC or Luer) that match the sets used in clinical cell processing.

• Cell Therapy-Specific Porting:

  • Inoculation and Sampling: Dedicated lines for the sterile introduction of patient cells and frequent, needle-free sampling.

  • Media Exchange: Optimized for rapid, automated media exchange without removing the bag from the rocking platform.

  • Harvest Port: A specialized bottom-drain port for high-recovery harvesting of the final cell product.

• Film Consistency: Uses the same S80 polyethylene film as the standard Flexsafe® line, ensuring that results from early-stage research on a Biostat® RM can be directly translated to the RM TX for clinical trials without new leachables/extractables studies.

 

Key Features for CGT Workflows

• Low-Shear Environment: The rocking motion provides high gas transfer (kLa) without the mechanical stress of an impeller, which is critical for maintaining the phenotype and viability of primary human cells (e.g., CAR-T cells).

• Scale-Out Capability: Because these systems are compact and automated, a single facility can operate dozens of RM TX units in parallel to treat multiple patients at once.

• Pre-installed Sensors: Every TX bag comes with pre-calibrated, single-use optical sensors for pH and DO, enabling "plug-and-play" operation without manual probe calibration or sterilization.

 

Primary Applications

• CAR-T and TCR-T Cell Therapy: Expansion of modified T-cells from leukapheresis products.

• Natural Killer (NK) Cells: Large-scale expansion of NK cells for "off-the-shelf" allogeneic therapies.

• Stem Cell Expansion: Cultivation of mesenchymal stem cells (MSCs) for regenerative medicine.

• Viral Vector Production: Production of lentivirus or AAV in suspension-adapted HEK293 cells at the 10 L to 50 L scale.