Elegen and Nutcracker Therapeutics have launched a pilot programme to showcase a fully cell-free manufacturing platform for RNA-based personalised cancer therapeutics (PCTs).
The initiative aims to enhance the accessibility and scalability of PCTs by reducing turnaround times and bioburden and endotoxin risks, advancing the production process.
Nutcracker’s NMU-Symphony system, the second generation of its Nutcracker Manufacturing Unit, offers a faster and more scalable GMP RNA manufacturing platform.
It is expected to address the current challenges in PCT production, including speed, reliability, and cost, and production of GMP-grade RNA, which is slow and inefficient.
The system reduces the turnaround time to three weeks, from RNA sequence design to drug product release, effectively halving traditional timelines.
By integrating Elegen’s cell-free GMP-ready DNA template production, it supports the synthesis of longer, complex neo-antigen sequences while mitigating contamination risks.
Nutcracker Therapeutics co-founder and chief technology officer Benjamin Eldridge said: “We’re not just improving our manufacturing process, we’re laying the foundation to democratise 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.
“This is a key step toward our mission of delivering scalable, low-cost, and rapid formulated RNA manufacturing for individualised therapies.”
The collaboration aims to democratise PCTs, making them more accessible and affordable for developers, which can significantly impact cancer patients by saving critical time.
Elegen’s ENFINIA DNA technology complements Nutcracker Therapeutics’ RNA-based PCT development process, which utilises artificial intelligence and machine learning.
Nutcracker uses its CodonCracker RNA design software, NMU-Symphony microfluidics biochip-based system, and ProcessVision technology for real-time monitoring.
Together, the technologies facilitate the efficient, flexible, and GMP-ready production of individualised nanoparticle-formulated RNA therapeutics.
Elegen founder and CEO Matthew Hill said: “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.
“By eliminating cells from the process, we can accelerate the development and evaluation of new therapeutic modalities, helping patients receive treatment as quickly as possible.”
