Evox Therapeutics has developed a potency assay for extracellular vesicle (EV)-based products, which can be adapted for future products in their pipeline. The assay has been pre-qualified and transferred into a quality control (QC) laboratory, with plans for full qualification during a first-in-human study next year.
The assay measures potency by dosing EV products at different concentrations onto an immortalized adherent cell line. After allowing the cells to grow, the cell lysates are tested on a Jess Simple Western system, providing a quantitative readout that determines a dose-response curve.
This approach aims to simplify the batch release process, avoiding the need for extensive testing that could consume significant product yield. The company anticipates that this potency assay will facilitate commercial production and support multiple products in their pipeline.
Source: genengnews.com · Image: lab technician checks blood sample (CC0)
Get started today with Solo access →
