Closed-Herd Technology and Processes
A bovine closed-herd has an advantage in that the animals within the herd are not exposed to potential carriers of diseases or parasites brought in from outside the herd. In fact, each ASM can be traced back to a specific certified animal, its parents, its health, its food supply and more. Each animal will receive a USDA inspection and full veterinary exam prior to slaughter and a UDSA inspection of its organs and flesh, plus a full necropsy by an onsite veterinarian before moving the ASM or xenotransplant material from the surgical suite to the ASM and xenotransplant processing and labeling area before releasing any animal parts by quality control. In broad terms, closed herd animal products ensure that controls have been put into place to prevent exposure of the parents and grandparents of the closed herd animal for it's entire lifecycle all the way beyond harvesting and through to patient care. PureMedFarma has the expertise and resources needed to satisfy the regulatory requirements and controls to meet the demand for safe, viral and disease free life saving components. Pure Med Farma is the first company to register with the FDA as a source of closed-herd materials.
- Animals are Raised in a Closed-Herd Environment Following All Quality Controls Put Forth by Regulatory Bodies
- Animals are Harvested in a Clean Room Facility with a Pre-Op Area Adjacent to the Surgical Room
- Corium, Tissue and Glands are Extracted in cGMP Certified Manufacturing Facility
All of our products have traceability to donor animal, parents and grandparents, assuring only the highest-integrity animals. All ASMs are shipped upon PA Approval to our (CPMG) manufacturing facilities for further processing into finished pharmaceuticals, devices and biologics.