Sartorius Stedim Biotech introduces BIOSTAT^® RM TX with Flexsafe^® RM TX for producing consistent quality cellular products

• New rocking motion single-use bioreactor system to culture cell products in working volumes up to 5 L
• Flexsafe^® RM TX bags enable reliable process performance for optimal cell growth
• Premiers at Phacilitate Leaders World 2019 in Miami

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 minimise leachables and extractables, guaranteeing consistent batch-to-batch culture performance of even sensitive cell types, such as genetically modified T cells.

The proprietary 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. Unlike other cell therapy expansion systems which use pumps for cell recovery, this unique gravity harvest concept reduces the risk of shear stress on these delicate cells, to maximise cell number recovery.

A benefit of using the BIOSTAT^® RM TX bioreactor in combination with the Flexsafe^® RM TX bag for cell culture is the possibility for walk-away monitoring and culture control.  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 sophisticated 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, saving labour, time and effort with manual sampling and also minimising contamination risks to precious patient cells.

Utilising 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^™.

“Combining single-use technology with advanced automation for the expansion of cell products ensures control of process variability and enables safe, robust and affordable cell production,” explained Dr. Franziska Faulstich, Global Product Manager Regenerative Medicine and RM Bioreactors at Sartorius Stedim Biotech. “Working extensively with leaders in the cellular immunotherapy field, we have identified the right technologies and best practice workflows, which we have incorporated into our new BIOSTAT^® RM TX bioreactor,” she added.

Cell product developers visiting Booth 410 at Phacilitate World Leaders 2019 will discover how using this cleverly designed system can help improve their process performance, and as a result the integrity and consistency of their promising cell therapies in development.

BIOSTAT® RM TX and Flexsafe^® RM TX bags are for research and further manufacturing use only – not for use in therapeutic or diagnostic procedures. They are not CE marked for in vitro diagnostic use nor are they medical devices. Drug manufacturers and clinicians are responsible for obtaining the appropriate IND | BLA | NDA approvals for clinical applications.