Biopharmaceutical Automation Producing Consistent Quality Cellular Products
Sartorius Stedim Biotech introduces Biostat RM TX with Flexsafe RM TX for developing consistent quality cellular products. The company showcased its innovations at the recently held Phacilitate Leaders World 2019 event in Miami, USA.
Sartorius Stedim Biotech (SSB) has recently 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, was introduced at Phacilitate Leaders World 2019 in Miami, USA.
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, 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, mentions the company.
The proprietary 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 firm, 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 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 Bio Pat Via Mass sensor. The firm adds that 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 Bio Pat MFCS and Delta V.
Cell product developers that visited Booth 410 at Phacilitate World Leaders 2019 discovered 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.