FDA-registered facility
Manufactured by Re-Gen Active Lab in Irving, Texas.
QBio · Manufacturing
QBio is manufactured by our parent company, Re-Gen Active Lab, in our own FDA-registered facility in Irving, Texas.

The distinction
Many brands rely on an outside contract manufacturer. QBio is manufactured by Re-Gen Active Lab, giving our team direct visibility into sourcing, processing, testing, and release documentation.
That is what makes public characterization and lot-level traceability possible.
The facility
The Irving facility combines an ISO Class 3 cleanroom with ISO Class 7 support space and a monitored environment for professional manufacturing operations.
Manufactured by Re-Gen Active Lab in Irving, Texas.
Supported by ISO Class 7 space and documented environmental controls.
Air, pressure, and particulate conditions are monitored according to validated processes.
Process
Each stage is documented so that the release decision rests on identity, process control, and third-party results — not on a marketing promise.
Qualified U.S. cord-bank partners.
Eligibility review before release.
Controlled transfer into processing.
Documented manufacturing steps.
A stable, logistics-friendly format.
Third-party bioburden and endotoxin.
Lot-level documentation.
Batch consistency
Key components are quantitatively assessed, release testing is performed by third parties, and the resulting documentation follows the lot.
See the quality frameworkWhy lyophilized
The lyophilized format is designed for room-temperature storage and eliminates the need for cold-chain or dry-ice shipping. Each vial is reconstituted in the professional setting with QBio Gel.