Vitrafy Signs First U.S. Cell and Gene Therapy Deal

Vitrafy Life Sciences Ltd (ASX:VFY) announced an agreement with Charter Medical, LLC to install its cryopreservation ecosystem, comprising one Guardion cryopreservation freezing unit and the LifeChain software platform, at Charter Medical's Innovation Hub in North Carolina. The company said the agreement is its first in cell and gene therapy and its first in North America. Charter Medical will use the technology to support cryopreservation and freeze-curve optimisation studies for its cell and gene therapy customers.

The agreement will span an initial six-month term with deployment to occur in 2H FY2027, and Vitrafy stated that no revenue will be generated across the initial term agreed between the partners. The company said the deployment could open a pathway to further pipeline development and longer-term commercial relationships across the U.S. cell and gene therapy market, and noted in a footnote that therapy developers incorporate the ecosystem into their own FDA submissions, including to CBER, ahead of any human use. Managing Director and Chief Executive Officer Brent Owens said the agreement is Vitrafy's first product deployment in cell and gene therapy, incorporating both the hardware and the LifeChain software platform from the outset, and described freeze-curve optimisation across different cell lines as a real and unresolved problem for cell and gene therapy manufacturers. Charter Medical, part of the Solesis family of companies, is described in the announcement as an established supplier of consumables, bags and services to the Contract Development and Manufacturing Organisation and cell and gene therapy manufacturing sectors, with more than 30 years' experience, and as an ISO 13485/NSAI certified and FDA registered company.