01Registration
FDA-registered facility
Manufactured by Re-Gen Active Lab in Irving, Texas.
QBio · Manufacturing
We do not buy exosomes.
We make them.
QBio is manufactured by our sister company, Re-Gen Active Lab, in our own FDA-registered facility in Irving, Texas.
MANUFACTURED INIRVING
TEXAS
TEXAS
The distinction
Most exosome brands are marketing companies with a contract manufacturer somewhere.
It is worth being precise about what that means in practice. If a brand does not own its manufacturing, it is dependent on a third party for donor screening decisions, cleanroom standards, batch consistency and release testing — and it often cannot tell you much about any of them.
We can answer those questions because we make the decisions. Sourcing, screening, processing, lyophilization, testing and release all happen under one roof, with our name on the outcome.
The facility
Built for controlled, documented work.
The Irving facility combines an ISO Class 3 cleanroom with ISO Class 7 support space and a monitored environment for professional manufacturing operations.
02Environment
ISO Class 3 cleanroom
Supported by ISO Class 7 space and documented environmental controls.
03Documentation
Monitored environment
Air, pressure, and particulate conditions are monitored according to validated processes.
Process
Seven connected stages.
Each stage is documented so that the release decision rests on identity, process control, and third-party results — not on a marketing promise.
- 01Sourcing
Qualified U.S. cord-bank partners.
- 02Donor screening
Eligibility review before release.
- 03Recovery
Controlled transfer into processing.
- 04Processing
Documented manufacturing steps.
- 05Lyophilization
A stable, logistics-friendly format.
- 06Testing
Third-party bioburden and endotoxin.
- 07Release
Lot-level documentation.
CONTROLLED INPUTSReproducible protocolsQUANTITATIVE REVIEWBatch-to-batch assessmentEVERY BATCH · INDEPENDENT LABUSP <61> + USP <62>
USP <85>
USP <85>
Batch consistency
Consistency is a process, not a label.
Key components are quantitatively assessed, release testing is performed by third parties, and the resulting documentation follows the lot.
See the quality frameworkWhy lyophilized
Stability first. Simpler logistics by design.
Lyophilization supports stability in a dry format while simplifying storage and shipping. Unopened vials can be stored at room temperature without cold-chain or dry-ice shipping. After reconstitution with QBio Gel in the professional setting, use immediately or refrigerate and use within 72 hours.
Unopened storageRoom temperature
ShippingNo cold chain or dry ice
After reconstitutionUse immediately or refrigerate for up to 72 hours.