Watch That Car-go! Acceleration Towards MSC-EV Characterization

By Stephen Lenzini and Elie Zakhem

Translating extracellular vesicles (EVs) from MSCs into clinically viable therapies depends on more than scale—it hinges on consistency, characterization, and control. RoosterBio’s latest work puts MSC-EV production under the microscope, evaluating how variables like donor origin, tissue source, and culture format impact key product attributes. Using a standardized upstream workflow and robust analytical assays, we’ve examined critical factors such as particle count, protein content, RNA cargo, and CD73 activity across conditions.

The results provide a roadmap for biomanufacturers developing scalable, fit-for-purpose EV therapies—and point toward best practices in aligning EV production with CMC expectations for regulatory success.

Dive into the full article to see what it takes to characterize MSC-EVs for the clinic—and what it means for the future of regenerative medicine.