Enabling Mesenchymal Stromal Cells and Their Extracellular Vesicles Clinical Availability-A Technological and Economical Evaluation.

ABSTRACT: Mesenchymal stromal cell-derived extracellular vesicles (MSC-EVs) have shown significant therapeutic potential across a wide range of clinical conditions, complementing the progress of MSC-based therapies, some of which have already received regulatory approval. However, the high cost of these therapies has limited their accessibility, creating an urgent need to explore manufacturing strategies that reduce the cost of goods and selling prices. This study presents the design and simulation of a scalable manufacturing platform for the co-production of clinical-grade MSC and MSC-EVs using SuperPro Designer. Various production scenarios were evaluated to maximise manufacturing capacity while analysing their impact on economic performance. Our findings demonstrate that for MSC-EVs doses contain

SUBMITTER: Silva RM 

PROVIDER: S-EPMC11913891 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature