Regulatory and Safety
Direct Biologics is committed to quality and patient safety. We have robust cGMP/cGTP quality systems in place for every aspect of manufacturing, storage and distribution 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:9001/13485 certified facility with cGMP equipment in ISO 7 and ISO 5 cleanrooms. Part of our quality system includes document control, record control and process deviation control with a robust quarantine system that manages inventory only be released with approval by our Quality and Engineering teams.
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.
Our tissue processing and manufacturing occurs in a 30,000 square foot advanced cGTP processing and manufacturing facility in Florida, a state-of-the-art research and development facility in the Center for Novel Therapeutics in La Jolla, California, a tissue storage and distribution facility in Missouri, as well as offices in California and Texas. Our product packaging has been created and validated in accordance with ISO 11607 and have been tested for sealing parameters in line with ISO 16775 Annex Q, Transportation Feasibility testing to ASTM D42169 DC13 AL1 with Climate Conditioning to ASTM D4332 and Package Integrity testing and inspections to ASTM F1886, ASTM F88 and ASTM F2096.
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.
ExoFlo is an exosome allograft product isolated from human bone marrow MSCs. ExoFlo exosomes provide signaling proteins that modulate inflammation.
Exosomes are known to stimulate bioactivity and direct cellular communication. In topical applications, ExoFlo can help in the repair and reconstruction of tissue.
Contact your local representative for ordering information.
Articles & Education
1. Vizoso, F.J.; Eiro, N.; Cid, S.; Schneider, J.; Perez-Fernandez, R. Mesenchymal Stem CellSecretome: Toward Cell-Free Therapeutic Strategies in Regenerative Medicine.Int. J. Mol. Sci.2017,18, 1852.
2. Phinney, G.; Pittenger, M. Concise Review: MSC-Derived Exosomes for Cell-Free Therapy. Stem Cells 2017;35:851–858.