Compliant with FDA Current Good Manufacturing Practice (cGMP) and FDA Good Tissue Practice (GTP).
Quality first
Regulatory & Safety
Choose responsibly sourced regenerative products supported by documented safeguards, consistent processing, and careful handling.
Our commitment
Safety is built into every stage
Quality begins before donated tissue reaches the laboratory and continues through processing, preservation, documentation, and delivery.
BioGenix works with qualified partners and controlled facilities committed to responsible sourcing, informed consent, donor screening, standardized handling, and traceability.
Quality frameworkSource
to shipment
to shipment
One connected process with documented controls at every transition.
Our commitment to safety
The complete quality framework
The specific safeguards used from voluntary donation through final shipment.
Produced in a sterile, FDA-compliant laboratory.
Processed with rigorous safety, testing, and quality-control procedures.
Participating hospitals invite mothers expecting normal, healthy births to donate the resulting umbilical cord. Tissue once discarded after delivery can become a valuable source of regenerative biological material.
At the time of birth, a specialized nurse enters the delivery room to carry out the collection procedure.
With the mother’s informed consent, the umbilical cord is clamped after the baby is born.
The donated material is collected from the cord and taken to a sterile laboratory, where the cell allograft is processed for its intended use.
Laboratory specialists screen donated cords under AATB standards and process the cord material according to documented procedures.
Units are prepared in standardized concentrations to support accurate and consistent treatment doses.
Single-dose preparations are shipped on dry ice for maximum preservation.
Controlled laboratory handling
Screened. Processed. Documented.
Laboratory specialists evaluate donated cord tissue using established procedures intended to support sterility, quality control, standardized preparation, and accurate documentation.
Why these standards matter
Potential patient benefits being studied
Umbilical cord-derived cells, signaling proteins, and growth factors are studied for their restorative and tissue-supporting properties.
Regenerative approaches are being evaluated as less-invasive options that may help appropriately selected patients avoid more invasive procedures.
Clinical research continues across areas that include joint injury, arthritis, cardiovascular conditions, and immune-related disease.
For healthcare professionals
Information that supports responsible decisions
Qualified providers need clear information about sourcing, handling, storage, documentation, permitted use, and applicable requirements. BioGenix is committed to making product and quality information available so providers can evaluate options using their independent clinical judgment.
Let’s connect
Talk with our team