Flow Cytometric Assays For CAR-T Cell Manufacturing And Patient Monitoring, Involving Specific Car Detection Reagents, Stabilized Pre-formulated Cocktails, And Automated Data Acquisition And Analysis

By Marsilius Mues, Stefanie Biedermann, Monika Winkels, Katrin Lange, Laura Stiem, Eva Janz, Michaela Niemöller, Desiré Missing, Nadine Borgelt, Anja Brauchle, Tatjana Holzer, Christian Dose, Christiane Siewert, and Anne Richter

Unprecedented efficacy in targeting cancer has been demonstrated with CAR-T cell therapy. However, the CAR-T cell manufacturing process remains highly complex and demands extensive personnel and infrastructure resources. The CliniMACS Prodigy device, designed for automated cell processing, helps to overcome these hurdles by enabling the generation of CAR-T cells in a single, automated, and closed system.

Despite this advancement, robust and reliable assays are still required for necessary quality control (QC) procedures and accompanying CAR-T cell phenotyping efforts. To streamline the assessment of CAR-T cells during manufacturing and patient monitoring, we aimed to establish a set of flow cytometric assays prepared from recombinant antibodies along with CAR detection reagents. These assays were complemented by stabilized pre-formulated cocktails and additional tools for automated data acquisition and analysis, achieving the highest level of standardization, reproducibility, and convenience.

To further improve assay standardization, simplify and speed up the IPC/QC process, and reduce risks from manual handling, we developed stabilized pre-formulated antibody cocktails for these flow assays, featured in a single-tube format.

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