Unique Product Processing & Safety

Carmell’s production process utilizes allogenic pooled plasma that has been screened and processed by an FDA registered and AABB (American Association of Blood Banks) accredited U.S. blood bank and is therefore considered free of known blood-borne pathogens. We then rescreen the pooled plasma as a safety precaution using sensitive nucleic acid amplification technology (NAT), and use the steps of pasteurization and irradiation to remove any new viral contaminants that conventional screening may miss.

After screening, pooled allogenic plasma is clotted, lyophilized (freeze-dried) and ground into a powder. The powdered material is mixed with glycerol (plasticizer) and other components, such as crosslinking agents and fillers, as needed. These steps allows us to fine-tune the degradation of the final product and control the release of regenerative factors. The resultant mixture forms a dough-like material that can be formed into numerous forms and is shelf-stable retaining native plasma biological activity.

The final product is additionally terminally sterilized after packaging, meeting FDA’s and EMA’s (Europe) stringent requirements for pooled blood products to ensure safety.

Manufacturing REPAIR Putty

Manufacturing REPAIR Putty