Elegen and Nutcracker Therapeutics launched a pilot program to demonstrate what they label the industry’s first fully synthetic, cell-free manufacturing platform for RNA-based personalized cancer therapeutics (PCTs). The pilot marks another step toward making PCTs more accessible, timely, and scalable, according to officials at both companies.
As late-stage PCT clinical trials progress and therapy developers work to create the next generation of PCTs, the speed, reliability, scaling, and cost of traditional production methods pose a major challenge. Specifically, the first step of DNA template production is hindered by the use of bacterial cells in the process, which can be unreliable and introduce contamination that must be removed, noted a Nutcracker statement, which also stated that the second step of GMP-grade RNA production from the template is impeded by a slow, unreliable, and inefficient process in which only one therapy can be made per GMP suite.
Consequently, PCT production can be slow, costly, and does not scale for individualized therapies, pointed out a Nutcracker Therapeutics spokesperson.
Manufacturing paradigm needed
Nutcracker’s NMU-Symphony
system, the second generation of its Nutcracker® Manufacturing Unit (NMU), brings the fastest, most scalable, and cost-efficient GMP RNA manufacturing platform available today, claimed Benjamin Eldridge, co-founder and CTO of Nutcracker Therapeutics. Fully enclosed and built for speed, it delivers clinical-grade PCTs consistent with just a three-week overall turnaround time, from RNA sequence design to released nanoparticle formulated drug product—cutting traditional timelines in half, he continued.
By incorporating Elegen’s cell-free GMP-ready DNA template production, the combination of the two platforms will enable an even faster and more scalable synthesis of longer, more complex neo-antigen sequences, while eliminating risks of bioburden and endotoxin contamination, as maintained by Matthew Hill, founder and CEO of Elegen.
With a faster, more dependable, and lower-cost solution, Elegen and Nutcracker Therapeutics aim to democratize PCTs, making them accessible to more developers and saving critical time for cancer patients, where even days can make a meaningful impact, explained Hill.
“Integrating cell-free DNA with cell-free biochip-based RNA production gives researchers and partners worldwide access to a more streamlined and cost-effective platform to rapidly test and advance new therapies,” he said. “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.”
“We’re not just improving our manufacturing process, we’re laying the foundation to democratize PCTs with truly scalable solutions,” added Eldridge. “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 individualized therapies.”
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