DuxCord™
DUXCORD™ CB-MNC
30M
CB-MNC
>90%
POST-THAW
Viability
99%
RBC
Non
DMSO
PRODUCT OVERVIEW
A cleaner cord blood cell product
TECHNICAL SPECIFICATIONS
Dux Cord is a cryopreserved umbilical cord blood mononuclear cell (CB-MNC) preparation sourced from full-term, consented donations and processed under cGMP conditions. With a proprietary non-DMSO cryoprotectant and >90% post-thaw viability, Dux Cord delivers a potent, ready-to-use biologic for qualified clinical and research applications.
Mononuclear cells (CB-MNC)
Human umbilical cord blood
30 × 10⁶ per vial
>90%
≥99%
Non-DMSO proprietary formulation
Vapor-phase liquid nitrogen
cGMP · 21 CFR Part 1271
Sterility, viability, identity
FDA-compliant HCT/P panel
WHY DUXCORD™
99% RBC-depleted
No-wash DMSO-free formulation
>90% post-thaw viability
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REGULATORY FRAMEWORK
Manufactured under 361 HCT/P standards
Processing does not alter the relevant biological characteristics of cord blood mononuclear cells. Density-gradient separation and RBC depletion meet the FDA's minimal manipulation standard.
Cord blood MNCs perform the same basic functions — hematopoietic reconstitution and immune support — in recipient as in the donor, satisfying the homologous use requirement.
DuxCord™ is available for qualified research institutions and investigators. COAs, cell characterization data, and regulatory documentation provided upon request.
Each vial carries a unique lot identifier with complete donor screening records, processing batch documentation, and QC release data maintained to 21 CFR Part 1271 standards.
APPLICATIONS
Where DuxCord™ is used
CLINICAL · HOMOLOGOUS USE
Regenerative Medicine
Procedures
Qualified HCT/P establishments may use DuxCord™ for homologous allogeneic procedures consistent with cord blood's basic functions. Appropriate for licensed practitioners operating within the 361 HCT/P framework.
TRANSLATIONAL · PRECLINICAL
Research &
Development
High-viability CB-MNC at a defined dose are well-suited for in vitro studies, co-culture experiments, immunological assays, and preclinical models investigating hematopoietic and immune cell biology.
ACADEMIC · INSTITUTIONAL
Cell Biology &
Immunology Labs
The non-DMSO formulation simplifies laboratory handling and removes wash steps that can introduce variability. Ideal for standardized protocols requiring consistent, reproducible mononuclear cell populations.
CLINICAL
TRIALS
Investigational
Applications
For IND-supported studies, DuxCord™ can serve as a starting material or study product with full lot documentation. Dux Bio supports trial sponsors with regulatory documentation and custom batch requests.
CORD BLOOD MONONUCLEAR CELL
Interested In Dux Cord
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Ready to order DuxCord™?
Contact the Dux Bio team to request a sample, obtain pricing, or discuss custom batch volumes. COA and full product documentation available to qualified purchasers.
DuxCord™ CB-MNC is regulated as a human cell and tissue product (HCT/P) under Section 361 of the PHS Act and 21 CFR Part 1271. It is not approved as a biological drug under 21 CFR Part 600, and no claims are made regarding its safety or efficacy for the treatment, cure, or prevention of any disease or condition. This product is intended for homologous use by licensed practitioners or for research use by qualified institutions. It is not for resale or further manufacture into a regulated biological. Practitioners are responsible for assessing applicable federal, state, and local requirements prior to use.