Investing In The NGS Rapid Analytics That Cell Therapy Needs

Manufacturing cell therapies has gotten faster, but release testing hasn't. Compendial sterility testing requires up to 14 days, mycoplasma testing can take up to 28, and adventitious agent testing is often outsourced. Together, these assays can consume roughly 12 mL of drug product per cycle, a serious burden in small autologous runs. This CDMO is investing in a dedicated next-generation sequencing program to address the problem.

The NGS core is integrated directly with manufacturing and process development rather than operating as an external vendor. It supports amplicon, whole genome and exome, RNA (including single-cell), complete plasmid, and methylation sequencing across Illumina, Oxford Nanopore, and 10x Genomics platforms. Applications include vector genome characterization, insertion site mapping, and CRISPR on/off-target assessment. Amplicon turnaround is under one week, advanced assays run 2 to 4 weeks faster than the industry standard, and the lab is the only Twist NGS Pro Lab in New England.

Building on that foundation, the rapid analytics program aims to replace the sterility, mycoplasma, and adventitious agent tests with a single multiplexed, automation-ready NGS assay. Early data show detection of five bacterial and fungal species and six viral species at 1 to 10 CFU or genome copies per sample. Targets include release turnaround of 6 days instead of 8, sample volume in microliters rather than milliliters, and a projected 65% reduction in COGS, with species-level contaminant identification in the same run. Longer term, the company plans to extend NGS to vector copy number, identity, and potency testing.