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How to Read a Certificate of Analysis (CoA) for MSC Exosomes

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A Certificate of Analysis (CoA) is the document that tells you what is actually in a given lot of mesenchymal stem cell (MSC) exosomes. For physicians and researchers sourcing research-grade material, the CoA is the single most important piece of paper in the transaction. Here is how to read one critically.

1. Identity

A credible CoA confirms that the vesicles are exosome-derived, typically by reporting characteristic surface markers such as CD9, CD63, and CD81. Identity data distinguishes genuine extracellular vesicles from generic protein or debris.

2. Particle concentration and size

Look for particle concentration (particles/mL) and a size distribution — usually from Nanoparticle Tracking Analysis (NTA) — with a mean diameter in the expected exosome range. For more on these methods, see the published work collected in our Exosome Research Library.

3. Purity

Purity is often expressed as a particle-to-protein ratio. This helps distinguish vesicles from co-isolated contaminants. A CoA that reports only total protein, with no particle count or purity ratio, tells an incomplete story.

4. Sterility and endotoxin

Research-grade preparations should be screened for sterility and endotoxin (for example, by LAL testing). These safety-relevant parameters are essential parts of a complete CoA.

5. Source and lot traceability

The CoA should identify the tissue source (for example, Wharton’s jelly umbilical cord MSCs) and a unique lot number that ties the documentation to the specific vial. Traceability from donor to delivery is a hallmark of a serious supplier.

Common red flags

  • No identity markers reported
  • Protein content given, but no particle count or purity ratio
  • Missing sterility or endotoxin results
  • No lot number or source tissue listed

Licensed professionals can request per-lot CoAs through the Physician Portal or contact our team.

Research-use-only. This article is provided for educational purposes and is not intended to diagnose, treat, cure, or prevent any disease.

Important Information

These statements have not been evaluated by the U.S. Food and Drug Administration. BioRegenEx products are not intended to diagnose, treat, cure, or prevent any disease.

Exosome therapy is an emerging regenerative approach. It is investigational, outcomes vary, and individual results cannot be guaranteed. Patient testimonials reflect individual experiences and are not representative of typical results.

References to regulatory standards — including Section 351(a) of the Public Health Service Act — describe the company’s stated quality and compliance approach and should not be interpreted as FDA approval or endorsement of any product.

This presentation is provided for educational and informational purposes only and does not constitute medical advice. Treatment decisions should always be made in consultation with a qualified, licensed healthcare provider.