PALO ALTO, Calif. — Countable Labs has launched specialized assay services designed to help cell and gene therapy developers and manufacturers evaluate and adopt its Countable PCR technology.
The company announced the services during the American Society of Gene + Cell Therapy meeting, which is being held May 11-15 in Boston. Countable Labs and its collaborators are presenting data at the conference on the use of Countable PCR for single-molecule counting in cell and gene therapy workflows.
Countable Labs said the new proof-of-concept assay services are intended to help developers measure and validate critical quality attributes more precisely as they move from early development into manufacturing.
Cell and gene therapy manufacturing requires high levels of accuracy and reproducibility because product quality and regulatory requirements are central to development. Countable Labs said its PCR technology is designed to minimize variability and improve precision through single-molecule quantification.
The company said Countable PCR can combine multiple assays for critical-quality-attribute-focused analytical development and produce reproducible data without requiring Poisson statistics or manual thresholding. The platform also includes DNA linkage analysis, which Countable Labs said can simplify genome integrity analysis.
“Cell and gene therapy applications require complete, unambiguous answers,” said Giovanna Prout, Chief Executive Officer at Countable Labs. “Countable PCR is the ideal technology for true single molecule counting, delivering highly reproducible results. Our assay services are designed for proof-of-concept studies, leveraging purpose-built assays to measure critical metrics for cell and gene therapy quality control enabling faster implementation into routine, high volume workflows.”
Countable Labs said its assay services can measure genome integrity and titer, detect residual DNA and quantify plasmid-derived impurities while producing audit-ready data. A new linkage visualization tool is designed to show these data in a single view, giving scientists a clearer picture of vector or cell line composition.
The services are intended as a rapid entry point for cell and gene therapy teams to test Countable PCR with their own samples and workflows. Countable Labs said the approach can support adoption either in-house or through a contract development and manufacturing organization partner.
The company said Countable PCR is built to process thousands of samples with consistent results, supporting high-throughput quality control across development and manufacturing pipelines.
“Countable PCR proved invaluable for quantifying sequence integrity of low-level impurities even against a dominant background of the AAV capsids and genomes,” said David Dobnik, Ph.D., Assistant Professor, National Institute of Biology. “The platform reliably resolved and quantified minor impurity species, providing critical information needed to meet the quality standards required in gene therapy applications.”
