What the characterization data scientifically proves
A supplier’s documentation is only as good as the assays behind it, and an attribute nobody measured looks identical to a clean result on the page. These references explain what each test establishes, what it cannot, and how to compare numbers across methods.
Written for licensed practitioners evaluating a preparation, and for anyone reconciling two certificates that disagree.
References
7 of 7 published. The remainder are in review and will appear as they are completed.
Reading an Exosome Certificate of Analysis
Three passes over a certificate, and where each assay is covered.
CD9, CD63, and CD81 Marker Panels
What tetraspanin panels establish, and what they do not.
NTA vs MRPS Particle Counting
Why two particle counts of the same material disagree.
MISEV2023 and Supplier Documentation
What MISEV is, what it is not, and which parts a supplier can be held to.
Sterility, Endotoxin, and Mycoplasma Testing
Three tests, three different questions, three blind spots.
How Exosomes Are Tested: Questions to Ask
The lab analysis behind a lot, and the questions worth asking.
Cold Chain Validation and Storage
Storage, excursion tolerance, and receiving checks.
These references explain analytical methods and documentation for licensed practitioner education. They are not legal advice, medical advice, or regulatory guidance, and they do not establish that any particular product or practice is compliant. There are no FDA-approved exosome products. Biomolecular signaling vesicle products distributed by ExaVeyra Sciences are supplied for topical aesthetic use by licensed practitioners and for laboratory and IND-authorized clinical research, and are not tissue products as defined by FDA guidelines.