Quality Assurance & Safety

Direct Biologics is committed to quality and patient safety. We have robust cGxP quality systems in place for every stage of our products. Our facilities are environmentally controlled and monitored for temperature and humidity with all freezers and storage equipment being monitored and maintained and our tissue is processed in an FDA inspected ISO:9001certified facility with cGMP equipment in ISO 7 and ISO 5 cleanrooms. 

Tissue tracking and traceability is a requirement of the FDA. Every tissue that we deliver to our customers is traceable back to the tissue donor and our strict donor acceptance criteria. Our donor screening includes the highly sensitive nucleic acid testing (NAT) for Hepatitis B virus (HBV), Hepatitis C virus (HCV) and HIV. Our products are tested for sterility, post-packaging, to meet USP<71> requirements.

The extensive intellectual property surrounding our proprietary methods for isolating allograft extracellular vesicles from human bone marrow MSCs and their utility have made Direct Biologics a leader in therapeutic innovation and this groundbreaking new technology.