Extracellular vesicles: setting your path to IND with advanced characterization packages

Extracellular vesicles (EVs) are an increasingly promising modality in the cell and gene therapy (CGT) field due to their ability to leverage the body’s natural delivery mechanisms. EVs exhibit several unique advantages, such as being immune-silent, having a broad delivery potential for diverse drug molecules, and the ability to cross the blood-brain barrier. Additionally, engineered EVs can carry therapeutic payloads, as demonstrated by successful clinical trials such as exoIL-12™ for treating cutaneous T cell lymphoma (CTCL). However, several challenges remain, particularly in characterization, scalable GMP manufacturing, and establishing functional assays. Advanced characterization techniques such as nano-flow cytometry and omics approaches enable a quantitative assessment of an EV sample at a single particle level, which can help to ensure product quality, streamlining clinical and commercial development.

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