How to Source Exosomes and
Mesenchymal Stem Cells
The documentation, characterization, and logistics questions that separate one supplier from another — and how Akira Biotech answers each of them.
Buyer GuidecGMP & ISO AlignedResearch Use Only
Ten questions to ask a supplier before you buy
If a supplier cannot answer all ten in writing, the material is not characterized well enough to specify in a protocol.
- 1.Does every batch ship with a certificate of analysis, and can you see a sample before you order?
- 2.What is the source tissue, and how old is the donor?
- 3.What donor screening was performed — pathogen testing, karyotyping, family history?
- 4.Which identity markers are confirmed, and are the absence markers reported?
- 5.What post-thaw viability is the batch released against?
- 6.For exosomes: what is the particle count per mL, and by what method was it measured?
- 7.What cryoprotectant is used, and is the culture medium animal-product-free?
- 8.Are the manufacturing partners cGMP- and ISO-aligned, and can that be evidenced?
- 9.How is the cold chain maintained from the laboratory to the receiving dock?
- 10.What are the minimum order quantity, the lead time, and the documentation supplied for import?
What a certificate of analysis must state
A COA is the per-batch document recording identity, purity, potency, and safety testing. Every Akira Biotech batch ships with one.
| Category | What is recorded |
|---|---|
| Identity | Immunophenotype for cell products; CD9⁺/CD63⁺/CD81⁺ vesicle markers for exosomes |
| Purity | Absence markers CD34−, CD45−, and HLA-DR− confirmed on every MSC batch |
| Potency | Post-thaw viability for cells; NTA-validated particle count for exosomes |
| Genomic stability | Karyotyping confirming chromosomal normality |
| Safety | Sterility and pathogen testing |
| Provenance | Source tissue, donor screening record, and batch number |
A COA that reports only a product name and a lot number is not a certificate of analysis. Ask for a redacted sample before placing a first order.
Donor screening and source tissue
For an allogeneic product, the donor is part of the specification. Ask how the donor was selected and what was tested.
- Source tissue: Wharton's Jelly in donated umbilical cord tissue — a perinatal source, biologically younger than any adult-derived alternative.
- Donors are healthy, first-pregnancy, and deliver by scheduled cesarean section.
- Multi-generation donor screening, karyotyping, and pathogen testing precede release.
- Preference for pre-pandemic birth tissue where safety demands it.
- The cord is recovered after delivery from material that is otherwise discarded — no procedure is performed on the donor to obtain it.
Identity and purity: the ISCT criteria
A population is only an MSC population if it carries the right markers and lacks the wrong ones.
- CD34−, CD45−, HLA-DR− confirmed on every batch. These absence markers are what demonstrate the population is not contaminated with haematopoietic or antigen-presenting cells.
- Karyotyping. Chromosomal analysis confirming genomic stability after culture and expansion.
- Exosome identity. CD9⁺, CD63⁺, and CD81⁺ tetraspanin markers, with the particle size distribution reported.
Potency: viability and particle count
Potency has to be a measured number on the batch record, not an adjective in a brochure.
- 98%+ post-thaw viability on the strongest-potency MSC products. Post-thaw viability — the percentage of cells alive after cryopreservation and thawing — is the key quality metric for any shipped cell product, and it is the number most often left unstated.
- 400 billion+ exosomes per mL as the standard concentration, rising to 1.2 trillion+ per 3 mL vial on the high-dose SKUs, validated by nanoparticle tracking analysis per batch.
- Ask what the measurement method was. A particle count without a stated method is not comparable between suppliers.
Cryopreservation and media
What the cells were frozen in determines what arrives, and what has to be washed out before use.
- DMSO-free, glucose-based cryopreservation. DMSO is the conventional cryoprotectant; a glucose-based method avoids it.
- Animal-product-free culture media throughout.
- Cryopreservation method is a legitimate question to put to any supplier, and the answer belongs on the COA.
Manufacturing standard
cGMP — current Good Manufacturing Practice — is the regulatory quality framework a manufacturing partner operates under.
- Akira Biotech is a distributor, not a manufacturer: material is produced by vetted laboratory partners operating under cGMP- and ISO-aligned standards.
- "cGMP-aligned" describes the manufacturing standard the partner laboratory works to. It is not a regulatory approval of the product, and no product described on this site is approved by the FDA or any other authority.
- Ask any supplier to distinguish between the two. A supplier that presents cGMP as an approval is describing something that does not exist.
Cold chain, MOQ, and lead time
The best-characterized material in the world is worthless if it arrives warm.
- Temperature-controlled cold chain from the partner laboratory to the receiving dock.
- Confirm the receiving site can accept and store cryopreserved material before the first order ships.
- Minimum order quantity and lead time are quoted per product and per destination.
- Import documentation is prepared for international destinations.
How pricing and quoting work here
No prices are published anywhere on this site, by design.
- Pricing is quoted per inquiry, against your requirements and order volume.
- Portal access is free and is approved in two to three business days.
- Every product page carries a direct inquiry link that names the product.
- Quotes cover the material, the documentation supplied, and the shipping method.
Research use only
Everything Akira Biotech supplies is supplied to licensed researchers, scientific professionals, and qualified institutions for legitimate research purposes.
These are experimental use cases, provided as a scientific reference for researchers. Except where noted, they did not use Akira Biotech materials, and results may not be reproducible with ours. Akira Biotech supplies laboratory reagents for research use only. Our products are NOT approved by FDA or any regulatory authority and are not for use in or on humans.
Need Access to Full Product Information?
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