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Single-use Bioreactor Expansion of Consistent Quality Cell Products

Editor: Doris Popp

The Biostat RM TX single-use bioreactor is a new wave mixed system developed by Sartorius Stedim Biotech (SSB) specifically for closed, automated expansion of consistent quality cell products such as ex vivo cellular immunotherapies.

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Biostat RM TX automated twin system for culturing of consistent quality cells.
Biostat RM TX automated twin system for culturing of consistent quality cells.
(Source: Sartorius AG)

This new GMP platform combines SSB’s established single-use Flexsafe bag technology with the company’s expertise in biopharmaceutical automation. It is designed for scale-out expansion of cells including patient-specific T cells. The closed system consists of an automated control unit and a up to two rocking platforms to gently agitate single-use Flexsafe RM TX bags (up to 5L working volume). The bag is the core of the system and built on SSB’s Flexsafe film, which is already well-established from clinical development to GMP manufacturing of vaccines and biologics. The film formulation is developed to minimize leachables and extractables, guaranteeing consistent batch-to-batch culture performance of even sensitive cell types. The proprietary Flexsafe RM TX bag is designed with a special port for hands-free gravity harvesting. In combination with the Flexsafe RM TX Harvest Device it reduces the contamination risks, maintaining cell integrity and cell viability.

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