Key considerations for shortening your CAR-T manufacturing process

Wednesday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

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Key considerations for shortening your CAR-T manufacturing process

Live30 webinars are thirty-minute presentations designed to update you on the latest innovations, applications, and data in a fast yet interactive format.

Autologous CAR-T cell therapy has demonstrated clinical efficacy in the treatment of B-cell malignancies, with particular promise in relapsed and/or refractory patients. Given the critical condition of these patients, shortening the vein-to-vein time is expected to improve therapeutic outcomes. At the same time, shortening the production time of a CAR-T cell product has the advantage of increasing production capacity and reducing manufacturing costs.

In this webinar, we will discuss how to establish a robust and automated 1 week manufacturing process for fresh CAR-T cell products. Several key process development considerations will be discussed and evaluated, including shelf life of a fresh drug product and in-process controls using standard methods such as flow cytometry .

A robust and flexible 1 week process has been established on the CliniMACS Prodigy® Platform, including the possibility to extend the process duration to achieve higher cell yields if required. The process enables the production of highly potent CAR-T cells, as demonstrated by in vitro and in vivo efficacy studies. The 1 week process generates sufficient numbers of viable, CAR-T cells for autologous treatment of patients, as demonstrated for several CAR constructs.

Don't miss this opportunity to learn about:

Hurdles you may face in shortening your CAR-T cell manufacturing process
Overcoming these challenges by using a platform for automated CAR-T cell manufacturing
Tackling obstacles related to in-process monitoring and QC of CAR-T cells produced in an accelerated manufacturing process

Nadine Mockel-Tenbrinck

Manager for Process Engineering, CMC Research and NCD at Miltenyi Biotec

Nadine Mockel-Tenbrinck leads a research and development team for CAR-T cell process engineering and related non-clinical development in immunotherapy at Miltenyi Biotec in Bergisch Gladbach, Germany. She is responsible for overseeing process development activities for the automated production of CAR-T cells, related NCD activities and CMC research to enable clinical trials in the field of immunotherapy. Nadine joined Miltenyi Biotec in 2009. Since then, Nadine has contributed to more than a dozen programs and projects to develop and establish the automated manufacturing of CAR-T cells in a GMP environment.