// PRODUCT LINES
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.
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.
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.
// DONOR SCREENING
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.
Request the current-batch Eurofins COA and specification sheet.
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