Mission Bio has announced the availability of the Tapestri VCN Assay, the first high-throughput commercial single-cell assay to simultaneously quantify vector copy number (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.
The company said 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mutagenesis and oncogenesis, the FDA has recommended VCN of less than five copies per genome, and FDA has stated in draft guidance that VCN should be determined for each CAR-T therapy lot.
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.
“We’re continuing to lead the pack in cell and gene therapy analytics with the Tapestri VCN Assay, which we believe to be the next big step in measuring critical quality attributes with single-cell sequencing,” said Yan Zhang, CEO of Mission Bio.
“Our biopharma customers have begun using this assay for data-driven decisions regarding the quality and safety of cell-based therapies through development. And we’ve only just begun.”
“In many regards, therapeutic opportunities in the cell therapy space have grown faster than the capacity to match them,” said Todd Druley, chief medical officer of Mission Bio.
“With the Tapestri VCN Assay and Mission Bio’s growing suite of single-cell multi-omics solutions for cell and gene therapy, the right analytical tools are becoming available to reassure drugmakers, regulators, and patients of their safety.”