Single-use Bioreactor Expansion of Consistent Quality Cell Products
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.
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.