Elegen , a leading next-generation DNA manufacturer, and Nutcracker Therapeutics , a global leader in next-generation RNA design and manufacturing, today announced the launch of a pilot program to demonstrate the industry’s first fully synthetic, cell-free manufacturing platform for RNA-based personalized cancer therapeutics (PCTs). The pilot program represents another step toward greater accessibility, faster availability, and greater scalability of PCTs.
As late-stage clinical trials for PCTs progress and therapy developers work on the next generation of PCTs, the speed, reliability, scalability, and cost of conventional manufacturing methods pose significant challenges. In particular, the first step of DNA template production is hampered by the use of bacterial cells, as this process can be unreliable and introduce contamination that must be subsequently remediated. The second step of producing GMP-grade RNA from a template is hampered by a slow, unreliable, and inefficient process that can produce only one therapy per GMP suite. Consequently, PCT manufacturing is slow, very costly, and cannot be scaled for personalized therapies. Therefore, a new manufacturing model is needed.
Nutcracker Therapeutics’ NMU-Symphony™ system, the second generation of the Nutcracker® Manufacturing Unit (NMU), offers the fastest, most scalable, and most cost-effective GMP-grade RNA manufacturing platform currently available on the market. Designed for speed, the fully enclosed platform reliably produces clinical-grade PCTs with a total turnaround time of three weeks from RNA sequence design to released nanoparticle drug product, half the traditional production time. By integrating cell-free, GMP-grade DNA template production, the two platforms are combined, enabling even faster and more scalable synthesis of long, more complex neoantigen sequences while eliminating the risks of bioburden and endotoxin contamination.
With the faster, more reliable and more cost-effective solution, Elegen and Nutcracker Therapeutics aim to democratize PCTs by enabling more developers to use them and achieve important time savings in cancer therapy, where a few days can make a difference.
“By integrating cell-free DNA with cell-free biochip-based RNA production, researchers and partners worldwide gain access to a more reliable, optimized, and cost-effective platform to rapidly test and advance new therapies,” said Matthew Hill, founder and CEO of Elegen. “By eliminating cells from the process, we can accelerate the development and evaluation of new therapeutic modalities, helping patients get treatment as quickly as possible.”
We’re not just improving our manufacturing process. We’re laying the foundation for democratizing PCTs with truly scalable solutions,” added Benjamin Eldridge, co-founder and Chief Technology Officer of Nutcracker Therapeutics. “Realizing this vision means developers will be able to produce clinical-grade RNA without investing hundreds of millions in infrastructure. This is a significant advance toward our mission to deliver scalable, cost-effective, and rapid manufacturing of formulated RNA for personalized therapies.
Elegen’s cell-free ENFINIA DNA, featuring an unparalleled combination of speed, length, precision, and complexity, seamlessly integrates into Nutcracker Therapeutics’ existing RNA-based PCT development process. The development process leverages artificial intelligence and machine learning via the CodonCracker™ software for RNA design, the NMU-Symphony™ biochip-based microfluidic system, and ProcessVision™ technology, which enables real-time performance and quality monitoring. Together, Elegen and Nutcracker Therapeutics’ technologies enable the efficient, flexible, GMP-grade production of personalized nanoparticle RNA therapeutics.
About Elegen, Inc.
Elegen brings unique insights and technical innovations to produce high-quality synthetic DNA faster, driving the next revolution in life sciences. Elegen uses proprietary cell-free technologies to produce longer, more complex, and higher-quality DNA in less time for the agriculture, chemical, healthcare, and pharmaceutical industries. Founded in 2017, Elegen is privately held and based in the San Francisco Bay Area.
For more information, visit elegenbio.com and follow us on LinkedIn and X (Twitter) .
About Nutcracker Therapeutics, Inc.
Nutcracker Therapeutics, Inc., is a biotechnology company dedicated to making RNA accessible to therapeutics developers by combining advanced technologies with highly precise biosynthesis. The company’s mission is to democratize safe and effective RNA-based therapeutics through its comprehensive technology platform for designing, delivering, and manufacturing RNA molecules. Nutcracker Therapeutics’ unique scalable RNA platform enables significant cost and turnaround time reductions while ensuring the highest quality.
For more information, visit www.nutcrackerx.com .
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