Product Sourcing at Keystone Biologics
Natural biologics have been around for decades in many different forms. New providers often have questions about our process and how we screen donors before continuing.
Keystone Biologics products are donated from consenting mothers at the time of delivery. We cultivate the product safely, meeting the highest quality assurance standards to be utilized in clinical programs.
01
Step 1
Donors are put through a detailed screening process to check for any communicable diseases. A medical and social history is also collected and reviewed to ensure the mother meets the eligibility requirements.
02
Step 2
Tissue is collected after full term live births by c-section and conducted by licensed professionals.
03
Step 3
Tissue is processed during a 48 period after collection.
04
Step 4
We follow strict protocols to clean and decontaminate tissues during the processing period. This ensures the tissue is free of pathogens and other contaminants.
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Step 5
Each tissue is uniquely identified and processed in a manner that is adherent to all applicable regulations.
06
Step 6
The products is preserved in a slow rate freezing process and stored at -80°C.
07
Step 7
Samples undergo a quarantine process until testing is complete to ensure sterility.
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Step 8
Once testing is complete, the sample has passed all tests, and met the internal release criteria, it moves from quarantine and is ready for purchase.
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Step 9
Sales are completed and shipped to doctors and hospitals on dry ice to ensure preservation.
