A GMP-Compatible Reagent Enables Ten-Fold Improvement In MSC-EV Recovery During Scalable Downstream Processing

By Ramon Castellanos-Sanchez, PhD, Stephen Lenzini, PhD, Jae Jung, Madeline Cramer, PhD, Elie Zakhem, PhD, and Jon Rowley, PhD

Filter fouling during mesenchymal stromal cell-derived extracellular vesicle (MSC-EV) manufacturing is one of the most consequential sources of yield loss in your downstream processing workflow. Without intervention, cumulative particle recovery through a full DSP sequence can fall below 5% of harvest, raising cost of goods and constraining lot sizes for clinical programs. This poster presents systematic optimization data for Agent V-DSP, a GMP-compatible reagent applied to conditioned medium prior to filtration. At 1X concentration for 30 minutes, Agent V-DSP reduced membrane fouling pressure across both 2D and 3D microcarrier bioreactor-derived material, improving cumulative particle recovery to more than 50%. Tetraspanin marker profiles (CD63, CD9, CD81) and CD73 enzymatic activity were preserved, confirming that critical quality attributes remain intact.

If you are scaling MSC-EV production and facing yield constraints that limit your clinical or commercial path forward, access the poster now to review the full treatment optimization dataset and end-to-end DSP comparability results.