Large-scale production of extracellular vesicles: Report on the “massivEVs” ISEV workshop

Journal of Extracellular Biology, 2022 · DOI: 10.1002/jex2.63 · Published: September 14, 2022

Simple Explanation

Extracellular vesicles (EVs) are crucial for translating research discoveries into EV-based products. The “massivEVs” workshop discussed challenges in this translation. The workshop addressed technologies for EV manufacturing, upscaling, GMP compliance, validation, and regulatory issues. Academia and industry collaboration is important for validating EV manufacturing, scalability, efficacy, reproducibility, safety, and regulatory compliance.

Study Duration

Not specified

Participants

∼50 attendees selected on the basis of research area, expertise, abstracts outlining key interests, motivation statements.

Evidence Level

Level 5: Expert Opinion

Key Findings

1
EV purity may not always correlate with functionality, and co-isolates could contribute to function and stability.
2
Quality metrics tailored to specific EV products and their intended use are necessary.
3
There is significant potential in non-human EV sources, which are more easily tunable compared to human sources.

Research Summary

The “massivEVs” workshop focused on the challenges and potential solutions for large-scale EV production, bringing together experts from academia and industry. Key areas discussed included manufacturing technologies, upscaling, regulatory issues, and the importance of collaboration between academia and industry. The workshop highlighted the need for standardized quality metrics, consideration of EV stability, and exploration of non-human EV sources.

Practical Implications

Prioritize Functionality over Purity

Focus on potency and efficacy first, then assess safety and the influence of purity on both.

Develop Multi-Modal Test Matrices

Use defined assays to establish quality control for EV products.

Explore Non-Human EV Sources

Recognize the potential of sources like bacteria and microalgae.

Study Limitations

1
Regulatory guidance for EV-based products is not yet well developed or standardized.
2
Public opinion may impact acceptance of non-human EV-based products.
3
Lack of a gold standard separation process.

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