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Sourcing & quality

Product sourcing process

The field of natural biologics spans decades and comes in many different forms. New providers often ask us where our products come from and how we qualify donors before continuing with the natural biologic process. Our products are donated from consenting mothers at the time of delivery. Our products are safely cultivated and meet the highest quality assurance standards to be utilized in your clinical program.

Step

Prescreening

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.

Step

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).

Step

Distribution

All products are shipped on dry ice in validated shipping containers to ensure appropriate temperature is maintained.

From donation to delivery

  1. Donors are healthy women who are thoroughly screened for any communicable diseases. A medical and social history is collected and reviewed by our Medical Director to ensure that the mother meets all the eligibility requirements.
  2. Tissues are collected after full term live births by c-section and conducted only by licensed professionals.
  3. There is a 48 hour window to process the fresh tissue after collection.
  4. All tissues are cleaned and decontaminated during processing. We follow strict protocols to make sure our tissue is free of pathogens.
  5. Each tissue is uniquely identified by lot. Each lot is processed and is adherent to all applicable regulations.
  6. Preservation of product viability is ensured by a slow rate freezing process and storage at -80°C.
  7. To ensure sterility, samples from each lot are sent off to a third party testing facility. Each lot undergoes quarantine until the testing has been completed.
  8. When testing is complete, if the lot passes the rigorous testing phase and meets our internal release criteria, it moves from the quarantine stage and is eligible for sale.
  9. Sales are completed and shipped overnight to doctors and hospitals on dry ice to ensure preservation of the product.
  10. Individual product use is tracked internally by patient.

Important: This content is provided for educational purposes and research use only (RUO). It reflects the professional experience and academic perspectives of credentialed providers and is not intended to diagnose, treat, cure, or prevent any disease. Clinical application and regulatory compliance remain the responsibility of the licensed provider.

products are intended for cosmetic, research and/or homologous use products used and/or distributed by practitioner.The products are supplied aseptically and intended for single use. This product is intended for use by professionals only.

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