The Auragens Standard

A Higher Standard for Regenerative Medicine 

At Auragens, quality is not limited to the biologic itself. It extends to every system, process, and safeguard surrounding patient care.

That commitment is one of the reasons Auragens pursued and achieved AABB accreditation—an independent recognition of adherence to rigorous standards for cellular therapy and biologic quality systems.

A Standard Built Around Quality

AABB accreditation evaluates far more than a product. It examines the systems an organization has established to support quality, consistency, traceability, and patient protection.

From how materials are handled and documented to how teams are trained and quality events are addressed, accreditation provides an independent assessment of whether established standards are consistently followed.

For Auragens, accreditation isn't simply a credential. It reflects how we choose to operate.

Quality at Every Step

Achieving and maintaining accreditation requires a comprehensive approach to quality management. Areas evaluated can include:

Documentation & Traceability
Maintaining detailed records and traceability throughout relevant processes.

Personnel Training
Establishing training and competency systems for personnel involved in critical processes.

Quality Management
Implementing structured systems designed to maintain consistent standards across operations.

Deviation Management
Documenting, investigating, and appropriately addressing deviations when they occur.

Corrective Actions
Identifying root causes and implementing measures designed to prevent recurrence.

Continuous Improvement
Regularly evaluating systems and processes to strengthen quality over time.

Systems Designed to Protect Patients

In regenerative medicine, what happens behind the scenes matters.

Patients should be able to expect more than an advanced therapy. They should be able to expect disciplined processes, documented quality systems, traceability, trained personnel, and an organization committed to continually evaluating how it operates.

AABB accreditation provides an additional layer of independent oversight—helping demonstrate that Auragens' quality systems are evaluated against established standards.