Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry has announced the launch of the BIOSTAT RM TX single-use bioreactor, a new wave mixed system developed specifically for closed, automated expansion of consistent quality cell products such as ex vivo cellular immunotherapies.

This new GMP platform, which combines SSB’s established single-use Flexsafe bag technology with the company’s expertise in biopharmaceutical automation, will be introduced at Phacilitate Leaders World 2019 in Miami, USA (January 22-25 / Booth 410).

SSB’s new bioreactor is designed for scale-out expansion of cells including patient-specific T cells and is a closed system, consisting 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 by major global biopharma companies. The film formulation is developed to minimize leachables and extractables, guaranteeing consistent batch-to-batch culture performance of even sensitive cell types, such as genetically modified T cells.