IsoPlexis, which recently received an NCI grant, reports that it has published a technology note with Miltenyi Biotec in a co-marketing agreement. The tech note (“Getting the most out of your CAR-T bioprocessing with the CliniMACS Prodigy and IsoCode Single-Cell Chip”) showcases how the companies’ respective technologies can be used synergistically to optimize CAR-T bioprocessing workflows, said Jon Chen, IsoPlexis’ senior director of marketing. In particular, IsoPlexis’ single-cell functional characterization was used to evaluate cell therapy process changes, downstream of Miltenyi’s CliniMACS Prodigy® system.
“The CliniMACS Prodigy offers advanced integrated solutions to streamline cell processing workflows—from cell separation through cell culture to formulation of the final product. These cells produced in an automated fashion can then be analyzed by customers on IsoPlexis’ single-cell polyfunctional analytics platform, which automates the cellular analysis and washing steps associated with ELISA platforms,” explained Chen. “Improved end-to-end automation minimizes the need for human involvement in numerous steps, reducing human resource utilization and the risk of cell contamination, and it eventually may be used to ensure successful translation in cell therapy development.
“By analyzing the polyfunctionality and Polyfunctional Strength Index (PSI), a measure of immune potency, IsoPlexis systems provide an objective functional readout to better characterize the cell therapy product from heterogenous CAR-T cells.”
IsoPlexis previously announced its goal of advancing the field of current and next-generation CAR-T therapies through precision analytics of cell therapies. In July, IsoPlexis announced NCI funding for further commercialization of the company’s systems for precision quality analytics of cell therapies for both development and bioprocessing purposes.
“The IsoPlexis platform is the first automated system for advanced functional single-cell analytics and mapping to reveal correlative insights into true functional immune biology. The IsoLight provides functional and direct proteomic profiling of single CAR-T cells to define the complex nature of each CAR-T cell and which cytokines each cell actually produces, with direct proteomic detection, to orchestrate the immune system,” noted Chen.
IsoPlexis’ ability to capture the range of relevant cytokines from each CAR-T cell represents a unique secreted protein multiplexing capability that defines how heterogeneous CAR-T cells work, he continued. The IsoPlexis system quantitates the potency of these CAR-T cells by measuring the intensity of the cytokines secreted by highly functional cell subsets, often missed by traditional bulk ELISA profiling technologies or systems like flow cytometry that do not measure the truly released cytokines per cell, pointed out Chen.
“By measuring the true function of single cells, IsoPlexis systems have helped capture the potency of important and highly functional T-cell and other immune cell subsets, which has correlated with in vivo response, as published in Blood in 2018 with pre-infusion CAR-T product samples. Additionally, this ability to precisely measure fitness and potency has recently been used in the development of novel CAR-Ts for solid tumor, preclinically,” he said.
Recent data sets made public at a variety of conferences, such as AACR and the CAR-TCR Summit, illustrate the ability for IsoPlexis’ systems to use its precision single-cell analytics to provide correlative insights and advance, according to Chen, including solid tumor pre-clinical cell therapy development (TCR-T, NK Cell, & CRISPR edited therapies) and precision bioprocessing in CAR-T and bi-specific CAR-T therapy.