Two materials. Both documented.

B&H Bio supplies two MSC exosome material product lines, both characterized using cytokine array analysis, mass spectrometry proteomics, and MLR assays. Every batch is independently tested by Eurofins.

Regulatory notice: No exosome product is FDA-approved for therapeutic use in humans. Material is supplied for research, professional, and investigational use only.

Matrix

Amniotic fluid-derived MSC exosome material.

Matrix is derived from amniotic fluid obtained from full-term planned cesarean sections. At this stage of fetal development, amniotic fluid consists of water (98–99%), salts, proteins, and enzymes. The product is unadulterated — following procurement, the amniotic fluid is not mixed or diluted with any additional components.

Protein composition has been evaluated using array-scan analysis with a Human Cytokine Array (RayBiotech AAH-CYT-5-8) detecting 80 different cytokines. Composition and characteristics have been confirmed against original unprocessed amniotic fluid using both proteomics (Mass Spec) and the same cytokine array.

Mixed lymphocyte reaction (MLR) testing demonstrates that Matrix decreases secretion of inflammatory cytokines, supporting characterization of the material's properties.

Testing performed

  • Cytokine Array (RayBiotech AAH-CYT-5-8)80 targets
  • Mass Spectrometry ProteomicsComplete panel
  • Mixed Lymphocyte Reaction (MLR)72hr assay
  • Sterility (USP <71>)14-day, Eurofins
  • Endotoxin (USP <85>)<5 EU/mL
Request Matrix batch COA →
Matrix Specs Current batch
MaterialAmniotic fluid MSC exosome
Exosomes~1 trillion
Growth factors234
Particle size50–100 nm
SourceFull-term planned C-section
AdulterationNone (unadulterated)
FormatNon-lyophilized
CleanroomISO-5
Donor screening21 CFR 1271
COA issuerEurofins (3rd party)
Alocyte Specs Current batch
MaterialUCB-PM (cord blood)
Exosomes~4 trillion
Growth factors175
Stem cellsup to 100 million
SourceAllogeneic cord blood
ManipulationMinimally manipulated
CryopreservationDMSO
CleanroomISO-5
Donor screening21 CFR 1271
COA issuerEurofins (3rd party)
Alocyte

Allogeneic umbilical cord blood plasma combined with mononuclear cells.

Alocyte (UCB-PM) is an allogeneic, minimally manipulated product derived from umbilical cord blood collected from normal, healthy, planned cesarean section donors. The manufacturing methodology is designed to preserve naturally-occurring soluble proteins and nanoparticles, including exosomes present in full-term cord blood.

There is no addition or combination of any other substance or diluent during production besides the cryopreservation solution (DMSO). Two distinct and therapeutically important components — soluble proteins and exosome nanoparticles — have been extensively characterized.

Testing performed

  • Exosome characterizationComplete panel
  • Soluble protein analysisPreserved profile
  • Stem cell countUp to 100M
  • Sterility (USP <71>)14-day, Eurofins
  • Endotoxin (USP <85>)<5 EU/mL
Request Alocyte batch COA →

Donor qualification per FDA 21 CFR 1271.

All donors are consented and screened following FDA guidelines. Contract tissue recovery organizations hold approved IRB protocols. Tissue is obtained solely through voluntary donation using an IRB-approved informed consent form.

Donor eligibility: age 18–45, tested negative for communicable diseases, passed social/health history screening.

Hepatitis B (HBsAg)
Hepatitis C (HCV Ab)
HIV 1/2
CMV
HTLV I/II
Syphilis
West Nile Virus (NAT)
Zika Virus (NAT)
SARS-CoV-2
Chagas disease (T. cruzi)
HIV/HCV/HBV NAT
CLIA-certified lab

Evaluate the material on your own terms.

Request the current-batch Eurofins COA and specification sheet.

Request documentation →