Vitrafy Life Sciences Enters US Cell and Gene Therapy Space with Cryopreservation Agreement

Vitrafy Life Sciences (ASX: VFY) has made its entry into the US cell and gene therapy market by securing an agreement with North Carolina-based Charter Medical to deploy its cryopreservation ecosystem into Charter’s Innovation Hub focused on single-use biopharma cold chain logistics and cell therapy development.

Under the terms of the initial six-month agreement, Vitrafy will install the next-generation ecosystem at the Innovation Hub, supporting cryopreservation and freeze curve optimisation for Charter’s cell and gene therapy customers.

Vitrafy's system consists of its precision-engineered, liquid nitrogen-free Guardion mobile freezing units, as well as its LifeChain cloud-based software platform.

The Guardion unit delivers controlled reproducible freeze profiles across a wide range of cell lines, while LifeChain captures processing data to deliver improved cryopreservation protocols and outcomes for Charter’s operations.

The agreement is Vitrafy's first in the North American cell and gene therapy space, which comprises thousands of participants and registered contract manufacturers across the pharmaceutical sector.

High-Value Segment

The new agreement demonstrates the applicability of Vitrafy’s ecosystem beyond blood market activities, in a segment where the value of preserved biomaterial is high and cryopreservation performance is a recognised critical requirement for many manufacturers.

Charter is focused on offering improved outcomes for its single-use products, while Vitrafy’s ecosystem provides the freeze performance and data required to evidence them.

The combination is expected to open a pathway to further pipeline development and longer-term commercial relationships across the US cell and gene therapy market.

Vitrafy will commence deployment of its ecosystem in the second half of the 2027 financial year and no revenue will be generated across the initial term.

Ongoing Process Challenge

Vitrafy managing director Brent Owens said freeze curve optimisation was an ongoing challenge in the cell and gene therapy process which could be addressed by the company’s ecosystem.

"This agreement is a significant milestone as our first product deployment in cell and gene therapy, incorporating Vitrafy’s cryopreservation hardware and LifeChain software platform from the outset,” he said.

“Charter Medical has supplied the advanced therapy sector for more than 30 years and works with the CDMOs and therapy developers we are targeting.”

“This deployment puts our technology directly in front of those customers with a trusted market leader.”