Collaboration targets faster, lower-cost production of RNA-based therapies with reduced contamination risk

Elegen and Nutcracker Therapeutics have announced a pilot program to demonstrate what they call the industry’s first fully synthetic, cell-free manufacturing platform for RNA-based personalized cancer therapeutics (PCTs). The collaboration aims to streamline production, reduce contamination risk, and improve turnaround times, offering a scalable and more accessible solution for individualized cancer treatments.

Traditional manufacturing of PCTs is limited by complex, multi-step processes. The initial production of DNA templates often relies on bacterial systems, which can introduce endotoxins and require additional purification steps. Subsequent RNA synthesis typically occurs in single-use GMP suites, adding time, cost, and capacity constraints. These challenges contribute to long lead times and high development costs, creating barriers for broader adoption of PCTs.

Nutcracker’s NMU-Symphony system, the second generation of its microfluidics-based Nutcracker Manufacturing Unit, is designed to address these inefficiencies. It can produce clinical-grade RNA therapies within three weeks, from sequence design to formulated drug product. The system integrates AI-based design tools and in-line quality monitoring, offering a closed, automated approach to personalized RNA drug production.

The pilot program incorporates Elegen’s ENFINIA DNA technology, which enables rapid, cell-free synthesis of GMP-ready DNA templates. By eliminating cells from both DNA and RNA production steps, the collaboration seeks to remove a major source of variability and contamination, while also supporting the production of longer, more complex RNA sequences for individualized therapies.

“By integrating cell-free DNA with cell-free biochip-based RNA production, we’re providing a more reliable, scalable, and cost-effective platform to accelerate development of new therapies,” said Matthew Hill, founder and CEO of Elegen.

Nutcracker Therapeutics CTO Benjamin Eldridge added: “We’re laying the foundation to democratize PCTs. Our goal is to make high-quality RNA manufacturing accessible without massive infrastructure investments.”

The combined platform is being positioned as a plug-and-play solution for developers of personalized RNA therapeutics, particularly those focused on cancer immunotherapy. While still in early stages, the companies say this cell-free model could significantly reduce both development timelines and the infrastructure burden typically required to support individualized therapies.