Engineering and loading therapeutic extracellular vesicles for clinical translation: A data reporting frame for...

Area of Science:

• Biotechnology
• Regenerative Medicine
• Nanomedicine

Background:

• Extracellular vesicles (EVs) are gaining traction as drug delivery vehicles and for regenerative therapies.
• Their inherent biocompatibility, targeting ability, and biological activities are key advantages.
• Current limitations include challenges in scalable, efficient, and cGMP-compliant production and loading methods for clinical translation.

Purpose of the Study:

• To critically review EV engineering strategies for therapeutic applications.
• To focus on technologies suitable for clinical translation of EVs.
• To propose a data reporting framework for standardization in the EV field.

Main Methods:

• Literature review of EV engineering techniques.
• Analysis of methods for loading EVs with therapeutic payloads (drugs, nanoparticles, biologics).
• Discussion of technologies applicable to large-scale, cGMP-compliant EV production.

Main Results:

• EVs can be engineered to carry various therapeutic agents and imaging tracers.
• Significant hurdles remain in achieving clinical-scale production and loading of EVs.
• Existing methods require critical evaluation for their suitability in clinical settings.

Conclusions:

• EV engineering holds significant potential for advancing drug delivery and regenerative medicine.
• Overcoming production and loading challenges is crucial for clinical translation.
• Standardization through data reporting frameworks is essential for field progression.