Rapid microbial QC for closed CAR-T manufacturing: data from a simulated fill-finish study

Wednesday 08:00 PST / 11:00 EST / 16:00 GMT / 17:00 CET

Sponsor

Rapid microbial QC for closed CAR-T manufacturing: data from a simulated fill-finish study

Live30 webinars pack the latest innovations and applications into a data-rich 30-minute session.

Where should you sample within a closed CAR-T process, and how can you generate microbial results that keep pace with compressed manufacturing timelines? This webinar presents data from a simulated closed CAR-T fill-finish study evaluating rapid qPCR-based mycoplasma and sterility testing at four process stages, from post-expansion through final filled product.

By evaluating sampling location, cell density, and sample preparation, see how the speakers achieved robust method performance in a 5 hour workflow. You will take away practical considerations for evaluating rapid microbial methods within your own cell therapy workflows.

Attend this webinar to:

Review detection data for Mycoplasma orale at 10 genomic copies/mL, and for Pseudomonas aeruginosa and Candida albicans challenges at 99 CFU, in CAR-T matrices at 1 × 10⁶ and 1 × 10⁷ cells/mL
Compare results from a designated closed-system QC sampling port with final-product samples, and learn how to identify representative in-process sampling points that reduce use of final-product material
Learn how an adapted sample-preparation workflow incorporating CD45+ cell depletion can enable rapid sterility testing of high-cell-density matrices
Take away a framework for assessing sampling location, matrix characteristics, and time to result together, including how challenge studies and assay controls can be used to evaluate method performance in relevant CAR-T matrices

MinGin Kim, Product Manager, Thermo Fisher Scientific, will present the study findings.

Register now to learn how rapid molecular testing can complement your microbial control strategy and deliver results on timelines that match closed CAR-T manufacturing.