Exosome Documentation Standards Every US Clinic Should Know
When you order exosome material, the documentation is your only independent proof of what's in the vial. Here's what to look for.
As the exosome supply market matures, documentation standards are becoming the primary differentiator between suppliers. Clinics that understand what to look for — and what to demand — get better products and stronger liability protection.
The Minimum Documentation Package
- Certificate of Analysis (COA): Lot-specific, with sterility (USP <71>), endotoxin (USP <85>), and identity testing from an accredited lab
- Specification Sheet: Describes the current batch: exosome count, growth factor panel, particle size, source, processing parameters
- Batch Traceability: Documentation tying the vial to a specific donor, production run, and lot number
- Donor Screening Records: Tests per FDA 21 CFR 1271 — HIV, HBV, HCV, CMV, HTLV, syphilis, West Nile, Zika, SARS-CoV-2
COA Issuer Comparison
The entity that issues the COA matters as much as the tests themselves. An independent third-party lab (Eurofins, Nelson Labs) provides unbiased verification. A manufacturer-issued COA means the same organization that produced the material also tested it — creating a structural conflict of interest.
How B&H Bio Compares
B&H Bio is the only US wholesale exosome supplier currently providing a CLIA-certified, independent third-party COA (Eurofins) as standard documentation on every batch — available for review before purchase. Most competitors use in-house or manufacturer-issued COAs that aren't independently verified.