Vitrafy Life Sciences has secured its first foothold in the United States cell and gene therapy market through an agreement with Charter Medical to install its cryopreservation technology in the North Carolina company’s Innovation Hub.
The Melbourne-based company will install a Guardion cryopreservation freezing unit and its LifeChain cloud software platform at Charter Medical’s Winston-Salem facility, where the system will support studies for cell and gene therapy customers.
The deployment is an important strategic step for Vitrafy, extending its technology beyond its existing blood-market focus and placing it before a US customer base of therapy developers, biopharmaceutical companies and contract development and manufacturing organisations.
The arrangement is initially a six-month, non-revenue agreement. Deployment is expected in the second half of the 2027 financial year, with its immediate value lying in validation, customer access and the prospect of later commercial relationships rather than near-term sales.
Charter Medical will use Vitrafy’s platform to support cryopreservation and freeze-curve optimisation studies for its customers. This process is central to preserving cells used in advanced therapies, where differences in freezing conditions can affect cell recovery and, ultimately, manufacturing efficiency and clinical outcomes.
Vitrafy says its Guardion unit is designed to produce controlled and repeatable freeze profiles across a broad range of cell lines. Its LifeChain platform captures processing data, providing the information needed to refine cryopreservation protocols and assess outcomes.
Charter Medical has supplied single-use technologies and packaging consumables to advanced therapy, bioprocessing, and blood-management markets for more than three decades. The company is FDA-registered and ISO 13485 certified, and its customers include biopharmaceutical companies, contract manufacturers, and cell therapy developers.
Its Innovation Hub was established in 2024 in Winston-Salem’s Innovation Quarter, an innovation precinct associated with Wake Forest University School of Medicine and the RegenMed Hub. The site includes laboratory capacity for studies involving freezing, transport and protection technologies used in biopharmaceutical cold chains.
Vitrafy managing director and chief executive Brent Owens said the agreement represented the company’s first product deployment in cell and gene therapy and its first commercial engagement in North America.
He said freeze-curve optimisation across different cell lines remained an unresolved manufacturing challenge for many cell and gene therapy companies, making it a natural application for Vitrafy’s integrated system.
“Charter Medical has supplied the advanced therapy sector for more than 30 years and works with the CDMOs and therapy developers we are targeting, so this deployment puts our technology directly in front of those customers with a trusted market leader,” Owens said.
