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Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

Sartorius Stedim Biotech introduces a closed, automated platform for cell expansion

Sartorius Stedim Biotech (SSB), an international supplier for the biopharmaceutical industry introduced its BIOSTAT® RM TX single-use bioreactor at the Phacilitate Leaders World 2019 in Miami, USA last week. The newly designed platform is developed specifically for closed, automated expansion of consistent quality cell products such as ex vivo cellular immunotherapies.

The new GMP platform combines SSB’s established single-use Flexsafe® bag technology with automation. This, the company claims, could help improve process performance, and as a result the integrity and consistency of the cell therapies in development.

The system consists of single-use Flexsafe® RM TX bags, an automated control unit and up to two rocking platforms to agitate the bags (up to 5L working volume). The bag is the core of the system and is built on SSB’s Flexsafe® film, formulated to minimize leachables and extractables, guaranteeing 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. Gravity harvest is a unique feature and unlike other cell therapy expansion systems which use pumps for cell recovery, gravity harvest maximizes cell number recovery by reducing shear stress on delicate cells.

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 also 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 SSB’s single-use biomass sensor. These sensors make the system suitable for running continuously in fed-batch or perfusion modes, saving labor, time and effort with manual sampling and minimizing contamination risks to patient cells.

To scale-out production, users can attach a second rocking platform and Flexsafe® RM TX bag to each BIOSTAT® B control unit.

Dr Franziska Faulstich, Global Product Manager Regenerative Medicine and RM Bioreactors at Sartorius Stedim Biotech commented: “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. 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”.

Source: Sartorius Stedim Biotech Introduces BIOSTAT® RM TX with Flexsafe® RM TX for Producing Consistent Quality Cellular Products; Press Release

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