MSC-Derived Exosome Product
Synergy Biotech Exosomes is an allogeneic Wharton's Jelly MSC-derived exosome product. Synergy Biotech Exosomes is manufactured using our proprietary isolation and purification technologies. The natural cell origin of exosomes enables improved efficacy, biocompatibility, and reduced immunogenicity. Synergy Biotech Exosomes extensive characterizations such consistency and potency assays provide assurance of quality throughout the production process.
Quality Assurance
Synergy Biotech Exosomes is manufactured from
umbilical cords from full term deliveries. All donors
are pre-screened and undergo comprehensive
testing which includes the following:
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Behavioral Risk assessment
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Physical Assessment
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Donor Medical History
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Communicable Disease Testing
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Infectious disease testing is performed at a certified
laboratory in accordance with the clinical laboratory
improvement amendments of 1988 (CLIA) and
42 CFR part 493.
Our Process & Procurement
Prescreening
Synergy Biotech products are obtained from healthy, carefully screened mothers at the time of normal delivery. In addition to a stringent social screening interview, all mothers undergo serology testing to ensure there is no risk for a communicable disease. No harm is brought to the mother or her newborn and parents still have the option of storing the cord blood if desired.
Processing
Recovery of tissue is performed at the time of delivery by trained technicians in a sterile environment. All processing is done in a cGMP facility following the regulations of the FDA and the guidelines of the American Association of Tissue Banks (AATB) and the American Association of Blood Banks (AABB).
Distribution
All Synergy Biotech products are shipped on dry ice in validated shipping containers to ensure appropriate temperature is maintained.
Dedication to Excellence
Synergy Biotech is headquartered in San Antonio Texas is an international biotechnology company with over 15 years of experience in the development of clinical products. Synergy Biotech was established in 2003 and it has been a pioneer in regenerative stem cell therapies.
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