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

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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.

MinGin Kim, PhD

Product Manager at Thermo Fisher Scientific

Dr MinGin Kim is a scientist and innovator driven by a passion for bridging science and engineering to create impactful molecular diagnostics and analytical device technologies. She earned her Bachelor’s degree in Materials Science and Engineering from Yonsei University in Seoul, Korea, where she began developing miniaturized molecular analysis platforms and biomaterial-based technologies in both academic and industrial settings. Inspired by the growing need for accessible point-of-care diagnostics, she pursued her PhD in Medical Science at Texas A&M University, focusing on affordable microfluidic PCR platforms powered by Rayleigh–Bénard convection for portable molecular analysis.

Throughout her career, she has built deep expertise in microfluidics, molecular diagnostics, and analytical device development. Her research has spanned biosensors using E. coli outer membranes and nanowires, compact thermal cyclers, PCR chips, and advanced fabrication methods. She later joined Thermo Fisher Scientific as an R&D Scientist in the Genetic Sciences Division, where she led development efforts for multiplex assays across real-time and digital PCR systems while contributing to next-generation instrument and consumable technologies. Combining strong technical insight with a customer-centered mindset, she transitioned into product management to help shape strategic roadmaps and deliver innovative solutions aligned with emerging scientific and clinical needs.

In 1 Day

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