CRDMO capabilities are tailored for a full range of mRNA applications, including small-scale quantities for personalized cancer vaccines (PCVs)
=Nutcracker Therapeutics, Inc., a pioneering biotechnology company dedicated to enabling transformative RNA therapies through its proprietary technology platform, today announced its new contract research, development, and manufacturing organization (CRDMO) capabilities, which will provide next-generation design and biomanufacturing solutions for RNA drug developers.
Nutcracker Therapeutics’ manufacturing solutions can be scaled for an array of drug discovery needs, from small quantities of many RNA constructs, to large-scale applications, such as GMP-grade personalized RNA-based medicines for tens of thousands of patients every year, or larger amounts of a single RNA-based drug product.
“Speed to clinic for personalized RNA therapies will propel the next wave of growth for emerging RNA medicines,” said Igor Khandros, CEO. “In response to the need for mRNA COVID-19 vaccines during the pandemic, the manufacturing capacity for RNA was designed on an enormous scale with traditional technologies. In our view, the future of RNA is increasingly personalized, making the need for flexible and scalable biochip-based manufacturing all the more clear.
“Through the combination of our advanced manufacturing system, best-in-class design capabilities, and end-to-end RNA expertise under one roof, Nutcracker Therapeutics’ CRDMO services provide accelerated speed to the clinic for various RNA treatments, as well as to high quality, low-cost personalized medicines with on-demand capacity scale-out,” Khandros continued. “Our ambition is to contribute to the proliferation of RNA medicines with our advanced technologies for the sake of patients in need.”
Nutcracker Therapeutics’ CRDMO capabilities harness the power of the Nutcracker Manufacturing Unit (NMU), which is designed to support the broad development of RNA drugs from discovery and late-stage clinical trials, to commercialization – with minimal change in manufacturing protocol across each phase. The NMU is 21 CFR Part 11 compliant. The company’s Current Good Manufacturing Practice (cGMP) facility includes semiconductor-like, automated end-to-end manufacturing capabilities that enable a “scale-out” approach for expansion, which can be achieved by NMUs working in tandem. Based in Emeryville, CA, the 8,000 sq. ft. facility is capable of manufacturing personalized cancer vaccines (PCVs) for 2,000 patients annually, with a rapid turnaround time of three weeks from sequence to completed drug product.
At the heart of the NMU are biochips, which leverage microfluidics to compress an entire bioreactor, purification column and in-process monitoring into a mere 9 square inches. The biochips – which are single-use disposables for processing individual patients’ PCVs, hence minimizing the risk of cross contamination – have a flexible design to support customization, allowing for the development of PCVs. A single NMU can manufacture different drugs with minimal downtime by simply changing the biochip.
The manufacturing advantages of the NMU specifically designed for RNA include the precise control of reagent concentrations throughout reactions, maximizing yield and quality, while minimizing reagent wastage. Furthermore, the NMU is primed for the production of research-, clinical-, and commercial-grade materials that are high in purity and reproducibility. Nutcracker Therapeutics has compiled and reviewed manufacturing data from the NMU for over 2,000 RNA production cycles, and has received favorable feedback from the U.S. Food and Drug Administration.
To learn more about Nutcracker Therapeutics’ CRDMO capabilities and offerings, visit https://www.nutcrackerx.com/crdmo-services/. For more information on the NMU, visit here.
About Nutcracker Therapeutics, Inc.
Nutcracker Therapeutics, Inc. is a biotechnology CRDMO company that combines advanced engineering with high-precision biosynthesis to unlock the promise of RNA. The company’s mission is to drive forward the development of safe and effective RNA drugs and personalized cancer vaccines through its complete technology platform, which encompasses the design, delivery, and manufacturing of RNA molecules. Armed with this high-tech advantage, Nutcracker Therapeutics’ unique scalable RNA platform significantly reduces costs and cycle times, while keeping the highest quality.
For more information, visit www.nutcrackerx.com.
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