OUR PROCESS and TESTING
Our product is a cell‐free exosome formulation derived from Wharton’s Jelly mesenchymal stem cells. We offer two variants, including one sterile, aseptically filled saline product containing 20 billion exosomes per cc.
Fresh Tissue Processing and Cell Harvesting
Our process begins immediately upon receipt of a fresh umbilical cord, which is transferred into our ISO-5 Clean Room. We exclusively use fresh, never-frozen, umbilical cord tissue because freezing can damage cells, altering their behavior and reducing overall efficacy. The mesenchymal stem cells (MSCs) harvested from the cord are then subjected to rigorous characterization and performance testing to confirm their identity and assess their responsiveness—the key factor driving our exosome’s mechanism of action.
Optimized Cell Passage and Master Cell Bank
Our objective is not merely to produce exosomes, but to generate exosomes that are highly enriched with essential growth factors and anti-inflammatory agents, and structured to specifically target damaged or inflamed tissue. We conduct preliminary testing on the harvested cells to determine their responsiveness and decide whether to use the first, second, or third passage. As cells expand, their potency and responsiveness diminish; therefore, we limit production to cells up to the third passage, based entirely on their performance. Once the optimal passage is selected, we establish a master cell bank that undergoes comprehensive third-party testing before production begins.
To ensure batch-to-batch consistency, we stimulate the MSCs daily with a specialized, in-house developed xeno-free culture medium—free of animal products or foreign substances. This medium supports the cells without inducing unwanted proliferation, division, or differentiation in the bioreactors. Daily monitoring of cell activity allows us to adjust nutrient sources and stimulatory factors, ensuring that each batch adheres to stringent 351(a) consistency standards. This rigorous control enables us to produce a product of identical potency today, tomorrow, and decades into the future—even when using different tissue sources.
Controlled Production for Consistent Potency
Final Product Manufacturing and Quality Assurance
Once the cells have produced exosomes, the solution is concentrated 1,000-fold and sent for batch virology testing. After confirming the absence of contaminants, the concentrate is blended with standard 0.9% saline to achieve the desired formulation of 20 billion exosomes per cc. As a final quality assurance measure, 25% of every finished lot is analyzed by a third-party laboratory. This analysis includes sterility, endotoxin, and mycoplasma testing, as well as advanced proteomics, mRNA sequencing, and lipid profiling. These tests evaluate both the overall vial contents and the specific concentrations within each exosome, ensuring that every batch meets the highest standards of quality and functionality.
Our meticulous process guarantees that our exosome product delivers unparalleled potency and therapeutic efficacy, setting a new benchmark in stem cell-derived regenerative medicine.
Applications of Exosome Therapy
Due to their ability to modulate the immune system, promote regeneration, and reduce inflammation, exosomes are being explored for a wide range of medical and aesthetic applications, including:
-
Orthopedics & Sports Medicine: Cartilage regeneration, tendon repair, and treatment of osteoarthritis
-
Neurology: Neurodegenerative disease treatment (e.g., Parkinson’s, Alzheimer’s), stroke recovery, and traumatic brain injury repair
-
Aesthetic Medicine: Anti-aging, skin rejuvenation, hair restoration
-
Autoimmune Disorders: Modulation of overactive immune responses in conditions like rheumatoid arthritis and lupus
-
Cardiovascular Health: Repair of ischemic heart tissue and improved vascular function
-
Lung Diseases: Potential therapy for conditions like chronic obstructive pulmonary disease (COPD) and pulmonary fibrosis