Gene Therapies

Case Study

Gene Therapies benefit from systems that minimize contamination risks to the product as well as to the environment, enable high product recovery and fast processing times. The UniFuge® addresses those needs. The UniFuge is ideal for delicate cultures, such as lentiviruses, and replaces filtration during primary recovery, eliminating the issue of filter clogging and HCP going to downstream purification.

The Challenge

A company producing gene therapies using HEK293 cells was unsatisfied with the clarification performance of filtration as measured by NTU values. Their filtration process could not be efficiently scalable.

We Used

The UniFuge® Pilot. The UniFuge is ideal for delicate cultures and replaces filtration during primary recovery, eliminating the issue of filter clogging and increasing product recovery. We also recommend the UFMini® as a tool to conduct Design of Experiments (DoE) and further characterize the process as a scale-down model.

The Outcome

CARR Biosystems’ UniFuge demonstrated superior clarification performance to filtration in terms of greatly reduced NTU values, along with an increase in titer in the resulting centrate. The NTU values were reduced 80 to 90%. Processing time was also significantly reduced.