Mission Bio launches assay to meet FDA CAR-T safety standards
Mission Bio has launched an assay that it claims will prepare makers of cell therapies for new safety and regulatory standards.
The developer said its new VCN Assay, its latest CGT assay for the Tapestri single-cell multi-omics platform, is both simplifying a complex process and vastly improving the sensitivity of batch measurement.
"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."
The explosive growth in cell therapy development over the past few years has put regulators on the spot, and FDA has raised the bar for drugmakers to prove their cell therapies are safe, commented Mission Bio.
That means demonstrating modifications and edits to cells are happening as intended. “The VCN Assay improves on today’s complex, multi-tool approach that can miss potentially oncogenic outliers within a cell batch. It does this by simultaneously measuring vector copy number and transduction down to single cells.”
Photo credit: GettyImages/artisteer
