Our Sourcing Process
The field of natural biologics has evolved significantly over decades and encompasses many forms of regenerative medicine. One of the most common questions we receive is where our biologics come from and how donors are qualified before the process begins. All products used in our clinical programs are donated by consenting mothers at the time of delivery. Every product is safely cultivated and held to the highest quality assurance standards before it ever reaches a patient.
Step 1 — Donor Screening
Donors are healthy women who are thoroughly screened for communicable diseases. A full medical and social history is collected and reviewed by our lab partner's Medical Director to confirm that each donor meets all eligibility requirements before participation.
Step 2 — Tissue Collection
Tissues are collected following full term live births by cesarean section and conducted exclusively by licensed medical professionals.
Step 3 — Processing Window
All collected tissue enters a 48 hour processing window to ensure freshness and biological integrity from the point of collection.
Step 4 — Cleaning and Decontamination
Every tissue undergoes thorough cleaning and decontamination during processing. Strict protocols are followed to ensure all tissue is completely free of pathogens before moving forward.
Step 5 — Lot Identification and Compliance
Each tissue is uniquely identified by lot number. Every lot is processed in full adherence to all applicable regulatory requirements, ensuring complete traceability from source to patient.
Step 6 — Preservation
Product viability is protected through a controlled slow rate freezing process and storage at negative 80 degrees Celsius, maintaining biological integrity throughout the supply chain.
Step 7 — Third Party Sterility Testing
Samples from every lot are sent to an independent third party testing facility. Each lot remains in quarantine until testing is fully completed and results are reviewed.
Step 8 — Release Criteria
Once testing is complete, any lot that passes the rigorous testing phase and meets internal release criteria is cleared from quarantine and approved for use. If a lot does not meet standards it is not released.
Step 9 — Delivery
Approved products are shipped overnight on dry ice directly to our clinical locations to ensure preservation from lab to treatment. Every individual product use is tracked internally by patient for full accountability.
Disclaimer
Our biologic products are not FDA approved or licensed for the prevention, treatment, diagnosis, or cure of any disease or condition. All information provided is for educational and informational purposes only and does not constitute medical or legal advice. Individuals considering natural biologics therapy are encouraged to review all relevant information and conduct their own research before participating. All products are intended for cosmetic, topical, research, and homologous use only.