01
Identity
Does the record identify the material and the method used to characterize it?
For research, professional, and investigational evaluation only. No exosome product is FDA-approved for therapeutic use in humans.
Testing and traceability
Quality evidence should survive the handoff.
We organize evaluation around the product, lot, method, result and release decision—not around unqualified quality language.
02
Safety criteria
Do sterility and endotoxin entries show the named method, criterion and result?
03
Traceability
Can the product, lot, donor eligibility record and release document be reconciled?
04
Release
Is there an explicit decision that the reported results met the stated criteria?
Review framework
Five questions for every file.
| Question | What to verify | Why it matters |
|---|---|---|
| What is it? | Product name, form and identifier | Prevents document/product mismatch |
| Which lot? | Lot or batch number on the report | Connects the result to supplied material |
| How tested? | Named method and acceptance criterion | Makes the result interpretable |
| What result? | Actual value, conforming result or no-growth finding | Separates evidence from marketing |
| Who released it? | Issuer, reviewer and release decision | Clarifies accountability and document status |
Document hierarchy
Know what kind of record you are reading.
- Issuing laboratory reportThe original analytical record from the laboratory that performed the test.
- Manufacturer release recordA lot release decision that may incorporate multiple source records.
- Private-label summaryA compiled summary that should disclose that it does not replace the original record unless verified.
Issuer
Who signs the record.
A report is only as strong as the party that issued it. When the seller's own laboratory signs the certificate, the document is a manufacturer's self assessment. A report signed by two of the seller's benches is stronger, but it is still the seller. An independent, accredited laboratory with no commercial interest in the sale is a different category of evidence.
B&H Bio releases a report from an independent, accredited laboratory that is named on the document, alongside the lot release record and the identification of the material. Ask any supplier three questions: which laboratory signs, whether that laboratory is independent of the seller, and whether its name appears on the document you are handed.
State requirements
Where a state asks for the record.
Tennessee Public Chapter 1016, effective 1 July 2026, is the first state law to name exosome-based regenerative products. It sets a supplier documentation standard: particle counts for exosome products, a lot-specific sterility report, and a certificate of analysis for every product before it is used on a patient, from a facility registered with the FDA or accredited by a listed body.
That is the same record set B&H Bio releases with a lot: an issuing laboratory report, a lot release record, and identification of the material. It is a state filing standard, not FDA approval of any product, and requirements differ by state. Ask us for the current documentation on the lot you are evaluating.
Documentation available
Start with the records.
Tell us what you are evaluating. We will match the request to the relevant current-batch documentation.