Cell Therapies

Case Study

When producing Cell Therapies, cell viability and recovery are critical for product quality and economic feasibility. Additionally, maintaining sterility is a mandatory regulatory requirement since there is no option to perform terminal sterilization. The UniFuge® line is well suited for cell harvesting and washing, as it is both high performance and simple to keep sterile. The UniFuge products are closed systems that enable sterility with single-use modules that have an SAL level of 10–6.

The Challenge

A biotherapeutics company was using a bottle centrifuge to collect and concentrate viable T-cells and was obtaining unsatisfactory product recovery. Note that bottle centrifuges are not closed systems and are difficult to scale. And, due to the manual processing of the bottles in the biosafety cabinet, the variability run to run is higher than an automated system and the contamination risk is increased.

We Used

The UniFuge® Pilot. The UniFuge products enable low-shear cell harvesting and washing of the cells, resulting in high cell viability and recovery. In addition, they are closed systems that enable sterility with single-use modules that have a SAL level of 10–6. We also recommend the UFMini®, a tool that can be used to conduct Design of Experiments (DoE) and further characterize the process as a scale-down model.

The Outcome

CARR Biosystems achieved up to 98% recovery with 93.2% viability, in a closed, sterile environment with no cells detected in the centrate. The UniFuge ensures that the cultures are healthy and also facilitates future scaling-up and process consistency.

Additional Resources

View case studies about cell harvesting, cell washing and other cell therapy topics here.