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Methodological framework demonstrates an attribute-driven characterization approach for extracellular vesicle manufacturing, highlighting pathways for reproducible scale-up.
As extracellular vesicle (EV)-based therapeutics move closer to clinical and commercial reality, the field faces a defining challenge: translating biological complexity into reproducible, regulatorily defensible products. This article presents a structured characterization and process development framework, drawing on analytical and manufacturing data to illustrate how a disciplined, attribute‑driven approach supports EV programs from early development through to scale‑up.
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Davide Zocco (2026) studied this question.
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