About Us
Direct Biologics is a market leading innovator and science-based manufacturer of regenerative products.
Innovative
Direct Biologics was created to expand the science of cutting-edge human cell and tissue technologies through research and has built extensive intellectual property surrounding exosomes and their utility.
Safety
Direct Biologics is committed to patient safety. The ExoFlo™ manufacturing process is performed under controlled, specified and validated current Good Manufacturing Practice (cGMP) conditions that are compliant with the highest quality standards.
Quality
Direct Biologics’ provides quality products for healthcare providers and patients. All processes are performed in conformance with current Good Documentation Practices (cGDP), and exceptional quality standards are maintained to provide for the safety and effectiveness of our products.
Technologies
Exosomes – A New Frontier in Regenerative Medicine
Exosomes are extracellular micro-vesicles (30-150nm) that are involved in direct cell to cell communication. Direct Biologics’ ExoFlo™ exosomes are isolated from human bone marrow mesenchymal stem/ stromal cells (MSCs). They are purified using proprietary cGMP processing and are sterile filtered and tested per USP<71> sterility testing. The unique benefit to Direct Biologics exosomes is they provide a wide array of regulatory proteins to stimulate and modulate many processes within the normal healing cascade.
Exosomes are not cells. Exosomes are tiny lipid vesicles that are secreted from a cell and are about 1/1,000th the size of a cell.
Exosomes are regarded as the purest form of cellular signaling available because their function is to direct tissue and wound healing by activating cell responses. This is the newest generation of naturally bioactive products for regenerative therapies.
The exosomes in ExoFlo are paracrine signals that assist with local cell-to-cell communication. Exosomes induce changes in nearby cells that create the appropriate healing environment and aid in tissue repair. As the technology and discovery of new methods of treating patients has evolved, scientific evidence shows that the optimal way to provide true regenerative therapy is to directly provide the signals as its own therapy and avoid potential issues with delivering and keeping transplanted cells alive.1,2
Stem and progenitor cells by nature work to heal, repair, and restore the body. But, in some cases where there is a chronic abnormality, these cells are inhibited by an inflammatory state, work in an unregulated capacity and fail to replace lost cells. The 1,000+ regulatory proteins, RNAs and other biomolecules found to naturally occur in healthy tissue and in ExoFlo have been shown preclinically to help modulate inflammatory healing processes.2 This is accomplished by activating and recruiting local cells to revascularize the area and reduce the inflammatory response to allow natural healing.
Resources
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.
Our Products
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
Direct Biologics Announces New Advanced Tool in Regenerative Medicine with Launch of AmnioWrap™ Placental Allograft
AUSTIN, Texas, January 12, 2021 (Newswire.com)
https://www.newswire.com/news/direct-biologics-announces-first-patient-treated-under-phase-ii-21286954
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References
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.