What are Exosomes?
Exosomes are extracellular vesicles, discovered ~30 years ago. A subset of these extracellular vesicles in the 30–150 nm size range, known as exosomes, has gained extreme importance in recent times.
Exosomes were previously considered the ‘dust’ or ‘garbage bags’ of cells but have recently stolen the limelight as an agent mediating intercellular contacts by virtue of their small size, ubiquitous secretion, omnipresence, and ease of their migration in vivo.
Exosomes are nano particles that release naturally from a cells and mesenchymal stem cells. These particles are responsible for cell-to-cell communication. These messenger cells could release growth factors and other beneficial processes.
Exosomes are derived from all different types of MSCs.
ExoQure Exosomes (hWJ-MSC-EXO) are harvested from the hWJ-MSC growth media, filtered, and then concentrated.
Clinical-grade product manufactured in cMP approved process with confirmed particle size, identity, and count at customer-specified concentrations; MSC source used to derive exosomes FDA approved (EA-IND approval for Traumatic Brain Injury)
Low-passage umbilical cord Wharton's Jelly MSCs (most potent source of MSCs) grown in proprietary xeno-free, serum-free media and conditions ensures unprecedentedly efficient and specific exosome creation of unrivaled potency.
Pure cultures of zero-aged MSCs with no contaminating cell types, tested for sterility, endotoxins, bioburden, mycoplasma and a range of relevant pathogens certified by 3m party CLIA Lab (Certificate of Analysis provided for every lot)
EXOQURE PRODUCT QUALITY TESTING: CERTIFICATE OF CONFORMITY FDA Donor Screening and Donor Tissue Testing 21 CFR 1271 Requirements:
- Donor Tissue Screeningand Testingfor 13 infectiousdiseases by CLIALab
Final Product Safety Testing (FDA IND Somatic Cell Mfg Quality Guidelines)
- Final MSC Testing - Sterility by CLIA Lab
- Final MSC Testing - Endotoxin by CLIA Lab
- Final MSC Testing - Bioburden by CLIA Lab
- Final MSC Testing - Mycoplasma by CLIA Lab
- Final MSC Testing for 13 infectious diseases by CLIA Lab
Exosome Measurement & Characterization
- Final Exosome Measure
- Final Exosome Characterization
