Quality & Regulatory
Our standard is the regulatory standard
Many biologics on the market are lightly characterized. XytriX is made to a defined specification and documented to the standard the FDA requires for clinical study.
What that means
AABB-accredited facility
Our manufacturing facility in Frisco, Texas, holds AABB accreditation for cell therapy (somatic cells: MSC, umbilical cord), covering processing, storage and distribution under AABB Standards for Cellular Therapy Services, 12th edition. Manufacturing takes place in ISO 7 classified cleanrooms under cGMP.
Characterized and potency-tested
Every lot is tested for identity, purity, viability, sterility and potency before release.
FDA-engaged
Our programs proceed under Investigational New Drug applications reviewed by FDA's Center for Biologics Evaluation and Research, including review of our chemistry, manufacturing and controls.
Documented chain of custody
From donor screening to cryostorage to delivery.
Manufacturing in-house
Our Frisco facility handles processing, testing, cryostorage and release in-house, so every step from donor to dose is controlled and documented by TriCelX.
Our evidence standard