Implementing Automated, Scalable and Integrated Systems in Cell Therapy Manufacturing

Topic: Implementing Automated, Scalable and Integrated Systems in Cell Therapy Manufacturing

Synopsis:

The cell therapy field is experiencing rapid growth with several treatments receiving recent regulatory approval and several therapies currently in clinical testing. Manual processing during manufacturing can result in inconsistencies, contamination, and long throughput times. In addition, during manufacturing scale-up the maintenance of critical quality attributes of the product can be challenging. As a part of this workflow, the Gibco™ CTS™ DynaCellect™ Magnetic Separation System is designed for scalable and robust cell processing with the Gibco™ TS™ Dynabeads™ and Gibco™ CTS™ Detachable Dynabeads™ platforms. The instrument utilizes an integrated magnet-rocker and a fluidics panel for target cell separation and subsequent bead removal in a closed system. and consistently achieves >90% isolation efficiency of target cells with >95% purity with no effect on cell viability. Furthermore, automated Dynabead removal results in >85% target cell recovery. DynaCellect is highly scalable allowing up to 1 liter of reaction volume for cell isolation with throughput time of ~100 minutes. Similarly, Dynabead removal is achieved through a continuous flow over the rocker-magnet to ensure rapid processing of volumes suitable for autologous and allogenic workflows. Using CTS Detachable Dynabeads with the CTS DynaCellect Magnetic System prioritizes patient quality and safety while also creating greater workflow control.

Learnings from webinar:

The importance of a scalable and robust cell isolation and bead removal in a closed, automated instrument
How to achieve >90% isolation efficiency of target cells with >95% purity with no effect on cell viability
The benefit of avoiding manual processing during cell therapy manufacturing, which can result in inconsistencies, contamination, and long throughput times
How to maintain T cell central memory phenotype with CTS Detachable Dynabeads CD3/CD28 with an active release mechanism

Featured Speaker:

Alexandra Lisi

Senior Field Application Scientist,
Thermo Fisher Scientific

Alexandra Lisi is currently a senior field application scientist with Thermo Fisher Scientific. She has more than 10 years of industry experience in cell therapy, including process development and manufacturing of CAR-T, NK, HSC, and MSC therapies. She received her Masters of Engineering in Biomedical Engineering with a specialization in upstream cell therapy process development from Stevens Institute of Technology.

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