FRISCO, Texas, Oct. 6, 2025 /PRNewswire-PRWeb/ -- TriCelX, Inc. ("TriCelX"), a global translational leader in evidence-based biologics, announced FDA registration of its ISO Level 7 (FED 209E class 10,000 classification) cleanroom and FDA-compliant cell processing facility at The Baylor Scott & White Sports Therapy and Research Center at The Star in Frisco, Texas.
TriCelX, Inc. Announces FDA Registration of its Cell Manufacturing Platform at The Baylor Scott & White Sports Therapy and Research Center at The Star in Frisco, Texas
TriCelX, Inc. ("TriCelX"), a global translational leader in evidence-based biologics, announced FDA registration of its ISO Level 7 (FED 209E class 10,000 classification) cleanroom and FDA compliant cell processing facility at The Baylor Scott & White Sports Therapy and Research Center at The Star in Frisco, Texas.
TricelX's CEO, Jakes Jordaan, stated, "Stringent compliance with all FDA regulations ensures the safety, identity, fidelity, potency, and purity of our biologics. Our FDA-registered facility offers a globally harmonized, FDA-compliant cell therapy manufacturing platform, providing treatment options for patients worldwide."
Jakes Jordaan continued, "Powered by ACE, a comprehensive, AI-powered electronic Quality Management System (eQMS), we connect automated workflows across our enterprise in strict compliance with FDA regulations and guidance for ensuring the safety and quality of human cells, tissues, and cellular and tissue-based products."
About TriCelX
Led by renowned scientists and surgeons, we translate cutting-edge science into evidence-based personalized solutions. With locations in Texas, Utah, and Antigua, TriCelX offers patients globally harmonized cell therapy options. A galaxy of intercellular signals from umbilical cord-derived Mesenchymal Signaling Cells (UC-MSCs) allows MSCs to differentiate into connective tissue, regenerate neurons, reduce neuro-inflammation, and modulate the immune system. Additionally, TriCelX is pursuing a novel approach to deliver biological medical countermeasures to our military that address some of the unique challenges facing our warriors on the battlefield.
About the Baylor Scott & White Sports Therapy & Research Center at The Star
A game-changing sports performance and healthcare destination focused on safety and research in Frisco, Texas, at The Star, a sports and entertainment district that is home to the Dallas Cowboys World Headquarters.
Additional Information
For additional information, please visit https://tricelx.com/
Media
Kathryn Dziedzic
TriCelX Inc.
(855) 874-2359
SOURCE TriCelX
Share this article