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Extracellular vesicles (EVs) are secreted from all prokaryotic and eukaryotic cells. The application of EVs in therapeutics, clinical diagnostics, and drug delivery is expanding rapidly and the EV field is set to capitalize on this expansion through the development of next-generation therapies for regenerative medicine and cell-free therapies. The relevant critical quality attributes (CQAs) for EV therapeutics have not been defined, yet there is a clear need to develop EV-specific characterization methods based on the experiences gained from the manufacturing of liposome- and lipid nanoparticle-based therapeutics. This chapter discusses potential EV CQAs and describes analytical methods and tools that could potentially be utilized to quantitatively characterize the selected attributes. We focus mainly on methods and tools for characterizing/measuring EV particle size and particle size distributions (PSDs), particle number concentrations (PNCs), surface charge/zeta potentials (ZPs), protein cargo and nucleic acid cargo.

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The Need for Standardization of Extracellular Vesicle Characterization Methods

  • 章节

  • 发表日期：

    2025年

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  • Bryant C. Nelson,
  • Molly E. Wintenberg,
  • Samuel W. Schaffter,
  • Wyatt N. Vreeland

摘要

Extracellular vesicles (EVs) are secreted from all prokaryotic and eukaryotic cells. The application of EVs in therapeutics, clinical diagnostics, and drug delivery is expanding rapidly and the EV field is set to capitalize on this expansion through the development of next-generation therapies for regenerative medicine and cell-free therapies. The relevant critical quality attributes (CQAs) for EV therapeutics have not been defined, yet there is a clear need to develop EV-specific characterization methods based on the experiences gained from the manufacturing of liposome- and lipid nanoparticle-based therapeutics. This chapter discusses potential EV CQAs and describes analytical methods and tools that could potentially be utilized to quantitatively characterize the selected attributes. We focus mainly on methods and tools for characterizing/measuring EV particle size and particle size distributions (PSDs), particle number concentrations (PNCs), surface charge/zeta potentials (ZPs), protein cargo and nucleic acid cargo.