Sartorius Stedim Biotech (SSB) has launched 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 combines SSB’s single-use Flexsafe bag technology with the company’s biopharmaceutical automation.

The 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. The film formulation is developed to minimize leachables and extractables for consistent batch-to-batch culture performance of even sensitive cell types, such as genetically modified T cells.

The Flexsafe RM TX bag is designed with a special port for hands-free gravity harvesting. In combination with the innovative Flexsafe RM TX Harvest Device it reduces the contamination risks from manual handling, maintaining cell integrity and cell viability, according to the company. The bags include single-use sensors for pH, DO and viable biomass. These sensors are integrated in the BIOSTAT B control unit, and the system’s software is set-up for fully automated process control of gases, flow rate, filling volume and substrate addition. With culture volumes greater than 500 mL, on-line analysis of viable biomass is also possible by connecting the single-use BioPAT ViaMass sensor. These sensors make the system suitable for running continuously in fed-batch or perfusion modes.

Utilizing this bioreactor system, manufacturers can attach a second rocking platform and Flexsafe RM TX bag to each BIOSTAT B control unit to scale-out their production. The system also provides a standard interface to common Supervisory Control and Data Acquisition as well as Distributed Control Systems such as BioPAT MFCS and DeltaV.