TriCelX has announced that its cell manufacturing facility in Frisco, Texas is now officially registered with the US FDA.
“The FDA registration signals that TriCelX has built the infrastructure to operate in a highly controlled, compliant environment—an essential foundation for scaling cell therapy production beyond research settings,” said TricelX’s CEO, Jakes Jordaan.
The new facility includes an ISO Class 7 cleanroom designed to support production under FDA oversight.
The company has also embedded an electronic Quality Management System, known as ACE, to provide real-time traceability and auditability across its operations.
The location of the facility also positions TriCelX to perform in a unique way. The facility is located within Baylor Scott & White’s sports therapy and research campus. The integration of manufacturing alongside rehabilitation and sports-medicine research may help accelerate collaboration and application in orthopaedics and broader regenerative medicine programmes.
While FDA registration is a crucial step, it is not a guarantee of success. TriCelX will still need to sustain GMP-level standards, maintain supply chain consistency and meet evolving regulatory expectations for cell and gene therapies.
Still, FDA registration represents an important step forward for TriCelX as it looks to strengthen its capabilities in advanced cell manufacturing and position itself within a growing network of regulated facilities supporting the next generation of regenerative therapies.
"Stringent compliance with all FDA regulations ensures the safety, identity, fidelity, potency, and purity of our biologics,” said Jordaan.
TriCelX has announced that its cell manufacturing facility in Frisco, Texas is now officially registered with the US FDA.
“The FDA registration signals that TriCelX has built the infrastructure to operate in a highly controlled, compliant environment—an essential foundation for scaling cell therapy production beyond research settings,” said TricelX’s CEO, Jakes Jordaan.
The new facility includes an ISO Class 7 cleanroom designed to support production under FDA oversight.
The company has also embedded an electronic Quality Management System, known as ACE, to provide real-time traceability and auditability across its operations.
The location of the facility also positions TriCelX to perform in a unique way. The facility is located within Baylor Scott & White’s sports therapy and research campus. The integration of manufacturing alongside rehabilitation and sports-medicine research may help accelerate collaboration and application in orthopaedics and broader regenerative medicine programmes.
While FDA registration is a crucial step, it is not a guarantee of success. TriCelX will still need to sustain GMP-level standards, maintain supply chain consistency and meet evolving regulatory expectations for cell and gene therapies.
Still, FDA registration represents an important step forward for TriCelX as it looks to strengthen its capabilities in advanced cell manufacturing and position itself within a growing network of regulated facilities supporting the next generation of regenerative therapies.
"Stringent compliance with all FDA regulations ensures the safety, identity, fidelity, potency, and purity of our biologics,” said Jordaan.