An Improved Manufacturing Method for Infusible Extracellular Matrix Materials to Enable Efficient Scale-Up, Improved Efficacy, and Clinical Translation

Depth filtration plus tangential flow filtration (DF-TFF) produces infusible extracellular matrix (iECM) comparable to centrifugation–dialysis/lyophilization–filtration (C-D-F) while enabling higher iECM concentration.

• Why it matters: Manufacturing bottlenecks in C-D-F limit iECM output, concentration, and human handling, threatening compliance with cGMP and slowing clinical translation.
• What they did: The team replaced C-D-F with DF-TFF, then used multiple material characterization methods to compare DF-TFF iECM to C-D-F iECM and tested higher concentrations in acute myocardial infarction (MI) porcine and mouse multiple organ dysfunction syndrome (MODS) models.
• The result: Increasing iECM concentration via DF-TFF showed a dose-dependent response in acute MI porcine and mouse MODS, and enabled timely production from alternative tissue sources for scalable, cGMP-aligned translation.

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