Carmell’s production process utilizes allogeneic pooled platelet enriched plasma that has been screened and processed by an FDA registered and AABB (American Association of Blood Banks) accredited U.S. blood bank and each unit is individually tested to ensure that it is free from infectious viruses. As an additional safety precaution, the pooled plasma undergoes two orthogonal viral inactivation steps prior to processing into final product. The viral inactivation steps have been validated per FDA requirements by an independent laboratory.
Our patented manufacturing process allows us to fine-tune the in vivo degradation of the implanted product and control the release of regenerative factors. The final product is additional terminally sterilized after packaging, meeting FDA’s and European authority's stringent requirements to ensure safety.