Mission Bio launches first commercial high-throughput cell therapy assay for measuring vector copy number
- High-throughput, multi-omic single-cell Tapestri® VCN Assay quantifies vector copy number (VCN) and transduction in individual engineered cells in a single assay — saving precious time and sample while working to ensure safety and potentially reducing the risk of clinical holds.
- Increasingly stringent U.S. Food and Drug Administration (FDA) guidelines highlight the need to quantify VCN at higher resolution in chimeric antigen receptor (CAR)-T lots, recommending fewer than five copies per genome to minimize oncogenic risk
SOUTH SAN FRANCISCO, Calif., Oct. 6, 2022 /PRNewswire/ -- 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.
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mutagenesis and oncogenesis, FDA has recommended VCN of less than five copies per genome, and FDA has stated in draft guidance that VCN should be determined for each CAR-T therapy lot.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.
"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, MD, PhD, 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."
Zhang will share new insights on the cell and gene therapy market, as well as Mission Bio's advances to provide end-to-end support for drug developers through PAD, in a presentation at 1:30 p.m. PT on Oct. 11, 2022 at Cell & Gene Meeting on the Mesa in Carlsbad, CA.
To learn more about Mission Bio and the Tapestri® Platform, please visit www.missionbio.com.
About Mission Bio
Mission Bio is a life sciences company that accelerates discoveries and cures for a wide range of diseases by equipping researchers with the tools they need to better measure and predict our resistance and response to new therapies. Mission Bio's multi-omics approach improves time-to-market for new therapeutics, including innovative cell and gene therapies that provide new pathways to health. Founded in 2014, Mission Bio has secured investment from Novo Growth, Cota Capital, Agilent Technologies, Mayfield Fund, and others.
The company's Tapestri® platform gives researchers around the globe the power to interrogate every molecule in a cell together, providing a comprehensive understanding of activity from a single sample. Tapestri® is the only commercialized multi-omics research platform capable of analyzing DNA and protein simultaneously from the same sample at single-cell resolution. The Tapestri® Platform is being utilized by customers at leading research centers, pharmaceutical, and diagnostics companies worldwide to develop treatments and eventually cures for cancer.
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