SAN CARLOS & EMERYVILLE, Calif. — Elegen and Nutcracker Therapeutics have announced a pilot program to test what they describe as the industry’s first fully synthetic, cell-free manufacturing platform for RNA-based personalized cancer therapeutics (PCTs). The collaboration aims to streamline and scale up the production of individualized RNA treatments, cutting manufacturing times and reducing contamination risks.
The two companies are combining their technologies to address longstanding bottlenecks in the production of personalized RNA-based cancer therapies. Traditional methods rely on bacterial cells to produce DNA templates and require dedicated GMP (Good Manufacturing Practice) suites to produce RNA—processes that are slow, expensive, and difficult to scale.
Nutcracker Therapeutics’ updated NMU-Symphony™ system is designed to produce clinical-grade RNA therapies within three weeks from design to drug product release. The platform uses microfluidics and automated biochip technology to reduce production timelines by half compared to current standards.
By integrating Elegen’s ENFINIA™ DNA technology—which produces cell-free, GMP-ready DNA templates—with Nutcracker’s system, the pilot seeks to accelerate synthesis of complex RNA sequences used in cancer vaccines and other therapies. The fully cell-free process also reduces the risk of bioburden and endotoxin contamination, which are common concerns with cell-based systems.
“Integrating cell-free DNA with cell-free biochip-based RNA production gives researchers and partners worldwide access to a more reliable, streamlined, and cost-effective platform to rapidly test and advance new therapies,” said Matthew Hill, founder and CEO of Elegen.
Nutcracker Therapeutics CTO and co-founder Benjamin Eldridge added, “We’re not just improving our manufacturing process, we’re laying the foundation to democratize PCTs with truly scalable solutions. Achieving that vision means giving developers the ability to produce clinical-grade RNA without investing hundreds of millions in infrastructure.”
The companies aim to demonstrate that fully cell-free manufacturing can make personalized RNA cancer therapies more accessible to developers and reduce turnaround times—potentially giving patients faster access to treatments where timing can be critical.
Elegen’s ENFINIA DNA technology supports synthesis of longer and more complex DNA sequences, while Nutcracker’s platform integrates AI-driven RNA design tools, real-time monitoring via ProcessVision™, and biochip-based manufacturing in a compact system. Together, the technologies offer a scalable, flexible, and GMP-ready approach to individualized RNA-based cancer treatment.
