FDA Approved MSC Exosomes
WHY CHOOSE ADVANCED BIOLOGICS?
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At Advanced Biologics, we specialize in the manufacturing and distribution of high-quality mesenchymal exosome products for research use only.
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Regulatory Excellence & Purity – Our commitment to safety, purity, and regulatory excellence is reflected in every stage of our process—from donor screening and sourcing to production and batch testing.
Regulatory Focus & Quality Assurance
Advanced Biologics operates in full alignment with applicable regulatory frameworks, maintaining strict quality control measures. Each batch is tested to meet our internal specifications for purity and exosome concentration. If a batch does not meet these specifications, it is not released for distribution.
Ethical Sourcing – Our exosomes are derived from Wharton’s Jelly within full-term, healthy umbilical cords obtained through voluntary donation. All donors are pre-screened according to rigorous standards, including age, delivery method, and health history, to ensure the highest-quality starting material.
Comprehensive Testing & Transparency – Each batch undergoes extensive third-party analysis, and a Certificate of Analysis (COA) is provided with every order. This COA includes detailed specifications on particle concentration, surface markers, protein content, and sterility, ensuring full transparency for research professionals.
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Research-Driven Development – Our product has been the subject of multiple pre-clinical research studies. While the product is not approved for clinical use, it is being evaluated in ongoing investigational studies in collaboration with academic institutions.
U.S.-Based Manufacturing – All of our mesenchymal exosome products are manufactured in the United States using proprietary processes that prioritize consistency, integrity, and compliance with current Good Manufacturing Practices (cGMP) for biologics used in research.
At Advanced Biologics, we don’t just manufacture exosomes—we redefine what’s possible in regenerative medicine. When you choose us, you choose uncompromising quality, scientific integrity, and a product you can trust.
Our exosome products are currently under investigation and have not been approved by the FDA for the diagnosis, treatment, or prevention of any disease.