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

  • Ethical Tissue Banking

We view tissue banking as more than a process—it’s about building a community of trust. As a responsible tissue bank, we fulfill the expectations of recipients and donors through strong ethical and regulatory practice.

The safety of transplant recipients, donors, medical practitioners, and hospital staff is our paramount concern. We work exclusively with certified tissue procurement partners who meet our strict criteria:

Donor Selection:

We only accept bio-ethically donated human birth tissue from healthy, consenting mothers in the United States. Donors must pass a comprehensive medical background check, detailed blood screenings, and deliver via full-term, live, C-section births.

AATB Prioritization:

Collection techniques strictly follow AATB guidelines, prioritizing the health and safety of the mother and baby above procurement. We are committed to maintaining an FDA and AATB compliant supply chain and the highest quality procurement.

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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