Characterizing extracellular vesicles across analytical and process development

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.

What you will learn

01

How a three-tier framework of primary, secondary, and tertiary attributes structures EV characterization from early development through scale-up

02

Why purpose-built single-particle analysis platforms are essential for accurate EV quantification, given the swarm effect seen in conventional flow cytometry

03

How molecular assays, including surface marker expression and omics-based profiling, distinguish true EV populations from co-purified impurities

Key interests

Extracellular vesicles EV characterization Analytical development Process development Nanoflow cytometry Perfusion bioprocessing EV purification Potency assays Scale-up manufacturing

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