Sartorius launches GMP platform BIOSTAT RM TX single-use bioreactor

New cell therapy expansion system features a gravity harvest concept that reduces contamination risks and maximises cell number recovery

New BIOSTAT RM TX automated twin system for culturing of consistent quality cells

Sartorius Stedim Biotech has announced the launch of the BIOSTAT RM TX single-use bioreactor. The unit, the company said, is a new mixed system developed specifically for closed, automated expansion of consistent quality cell products such as ex vivo cellular immunotherapies.

The equipment will be introduced to the market at Phacilitate Leaders World 2019. he event takes place on 22-25 January
at the Hyatt Regency Miami

Designed as a new GMP platform, it combines Sartorius established single-use Flexsafe bag technology with the company’s expertise in biopharmaceutical automation.

The equipment will be introduced to the market at Phacilitate Leaders World 2019. The event takes place on 22-25 January at the Hyatt Regency Miami.

“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.

“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.

Key features

The BIOSTAT RM TX single-use bioreactor is designed for scale-out expansion of cells including patient-specific T cells. It is a closed system, consisting of an automated control unit and 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.

Reduced contamination risks

Sartorius said its 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," the company explained.

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.

"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," the company enthused.

BIOSTAT® RM TX and Flexsafe RM TX bags are for research and further manufacturing use only – not for use in therapeutic or diagnostic procedures.

Sartorius noted that both products "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".

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