Manufacturing & Quality Assurance
Industry Leadership and Compliance
StemRegenex Bio is an industry-leading manufacturer of advanced human and plant cellular and tissue-based products, including high-purity stem cells and exosomes. Our commitment is to provide our partners with biologics of unmatched quality, manufactured under the most stringent regulatory oversight.
Our entire production platform adheres to current Good Manufacturing Practices (cGMP). This foundation of quality ensures consistency, purity, and potency in every product lot we deliver.
99% Client Satisfaction
75% Returned Client
20+ Years of Experience
Manufacturing with
StemRegenex Bio
Our proprietary disruptive 3D technology with cellular activation and induction of endocytosis
Testing & Guidelines: Every lot manufactured is sent for sterility, endotoxin, screening infectious diseases and mycoplasma
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• Full Panel | Pathogen Screening
Viruses, blood, and tissue borne pathogens in accordance with AATB and FDA guidelines including HIV, HBsAg, HCV, HBc Total, HTLV I/II, RPR, HIV/HCV/HBV Ultrio, WNV NAT, CMV Ab, Zika NAT, Lyme Disease, Epstein-Barr Virus, E.coli, Candida, and COVID-19.
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• Animal studies
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• Toxicity screening
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• Purity & Environment
Endotoxin guidelines and USP 1116 Environmental Controls, both in accordance with AATB and FDA guidelines.