Mission Bio, the pioneer in single-cell DNA and multi-omics analysis, announced the availability of the Tapestri VCN Assay, the first high-throughput commercial single-cell assay to simultaneously quantify VCN and transduction at the level of individual cells. For the first time, developers of cell therapies like CAR-T cells will be able to apply multi-omic analysis to assess the cell-to-cell variability of vector copies within a batch, rather than averages gleaned from bulk analysis that can hide potentially oncogenic cells.
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Most cell therapy developers recognize the limitations of their current analytical tools for characterizing CAR-T product quality. Due to the risk of insertional mutagenesis and oncogenesis, FDA has recommended VCN of less than five copies per genome, and FDA has stated in draft guidance that VCN should be determined for each CAR-T therapy lot. Today’s marketed PCR-based approaches may be inadequate for full characterization of cell therapies, as they may underestimate the presence of dangerous cell clones within a cell population and obscure variability in manufacturing, either from scale-up or between batches.
Single-cell multi-omics with Tapestri is working to expand possibilities for the development of CAR-T and other cell therapies, where engineering is becoming increasingly complex and therapies in development contain multiple modifications. The new assay consolidates VCN with transduction measurements – reducing time, labor, and sample material required while eliminating variability due to different instruments. Because Tapestri® can measure VCN and transduction in the same cells together, the VCN Assay alone has the potential to accurately and comprehensively assess the vector dosage using a single sample. Adding on cell-surface proteins enables developers to assess the subclonal cell subpopulations that have been modified without the need for flow cytometry.
Mission Bio‘s Pharma Assay Development (PAD) group can facilitate the technology transfer of the VCN Assay, streamlining deployment to one’s institution, contract research organization, or contract development and manufacturing organization, of choice.