MISEV2023, in plain working language — from a named contributor.
The Minimal Information for Studies of Extracellular Vesicles 2023 update (MISEV2023) is the international consensus standard for EV research, published by the International Society for Extracellular Vesicles. BioThera's founder is a named contributor to the 2023 consortium. This is what the guideline asks of a defensible EV product.
Frédéric St-Denis-Bissonnette, PhD
Founder & CEO, BioThera Solutions. Named contributor, MISEV2023.
The field's quality framework, not a marketing badge
MISEV stands for Minimal Information for Studies of Extracellular Vesicles. First published by the International Society for Extracellular Vesicles in 2014, updated in 2018, and substantially rewritten as MISEV2023 with a multi-year consortium of EV researchers across academia and industry — BioThera's founder among them — the document defines the minimum characterization, reporting, and quality controls a study or product needs to defensibly claim it works with extracellular vesicles.
The guideline is deliberately framed as a floor, not a ceiling. A preparation that meets MISEV2023 has demonstrated, on a per-batch basis, that it contains particles of the expected size, that those particles carry markers of EV origin, that they are not contaminated with non-vesicular material that would confound interpretation, and that the isolation method behind the preparation has been disclosed in enough detail to be meaningful.
Most commercial exosome skincare products do not meet this floor. That is not a marketing slight; it is a working observation about an industry that grew faster than the characterization infrastructure under it. MISEV2023 is the field's collective answer to that gap.
Five working requirements that MISEV2023 imposes
The 2023 update is long. These five anchor what an EV product has to demonstrate to be defensible.
- 01
Multiple, complementary characterization methods
No single measurement is sufficient. EV characterization requires orthogonal methods — at minimum, a single-particle counting method (typically NTA), a marker panel covering transmembrane and cytosolic EV-associated proteins, an absence-of-contaminants screen, and morphology confirmation (TEM).
- 02
Method-level transparency
Isolation method must be named and characterized for its impact on the final preparation. "Proprietary isolation" without method-of-action disclosure to qualified partners is not MISEV2023-compliant.
- 03
Batch-specific reporting
Particle concentration, marker panel data, and contamination screen results must be reported per production batch — not as a generic product specification. A Certificate of Analysis describes the batch in the box, not the platform in the abstract.
- 04
Source-appropriate marker selection
Mammalian tetraspanin markers (CD9, CD63, CD81) and ESCRT-associated cytosolic markers (TSG101, Alix) were defined for mammalian EV systems. Plant-derived EVs require markers appropriate to plant biology and a contamination screen attentive to plant-specific co-purifying material.
- 05
Honest reporting of limits
Where measurements have known biases (NTA under-counting at very small sizes, marker enrichment that overlaps with non-EV particles), MISEV2023 expects acknowledgement of those limits rather than over-interpretation. The guideline is a quality framework, not a marketing one.
The cluster — three working articles on the load-bearing variables
Three deeper pieces working through the variables that MISEV2023 treats as non-negotiable, each written to the same editorial voice as the broader site: field-precise, conservative on claims, honest about limits.
Isolation
Why isolation method matters under MISEV2023
MISEV2023 does not endorse a single isolation method. It requires that whichever method is used be disclosed, characterized, and accounted for in the product specification. Three working consequences for EV product evaluation.
Counting
NTA versus other particle-counting methods under MISEV2023
Why Nanoparticle Tracking Analysis became the field standard, what it does well, where it fails, and which orthogonal methods MISEV2023 expects alongside it.
Markers
EV marker panels explained — CD9, CD63, CD81, TSG101, Alix, and the absence-of-contaminants requirement
What each marker actually tells you about an EV preparation, why no single marker is sufficient, and the contamination screen MISEV2023 expects alongside positive markers.
For clinicians, partners, and investors
MISEV2023 is the closest thing the EV field has to a quality contract. A manufacturer that operates inside it has, by construction, a defensible story to tell when a clinician asks what is in the bottle, when a procurement team asks what the CoA actually proves, or when a regulator asks what the basis is for a particular claim. A manufacturer that operates outside it does not have that story, regardless of marketing copy.
This pillar and the three supporting articles exist because we think every clinician evaluating an EV product should be able to ask MISEV2023-grade questions of their suppliers, including us, and get answers. The framework on this page is also the framework BioThera operates against internally — every mPDEV batch ships with characterization that maps to it.
Use this when evaluating any EV product
The clinician-facing evaluation guide turns these requirements into a five-question checklist for product selection. The For Clinicians hub walks through procurement, CoA workflow, and cold-chain logistics.