Nutcracker Therapeutics, a contract, research, development and manufacturing organization (CRDMO), announced the NMU-Symphony™ system, the second generation of its Nutcracker Manufacturing Unit (NMU). This milestone is accompanied by an expansion of the production capacity of its Good Manufacturing Practice (GMP) ready facility, in Emeryville, CA.
NMU-Symphony™ is a proprietary microfluidics biochip-based manufacturing platform used in the development and production of individualized RNA therapeutics, including personalized cancer therapeutics (PCTs). The biochips are single-use disposables for processing individual PCTs, reducing the cost of manufacturing and the processing cycle time. Through these end-to-end capabilities, together with its operational GMP-ready manufacturing facility, the company has the capacity to meet the ever-growing demand for individualized, low-cost, and rapid turn-around-time RNA production. With its 1,800 square-foot ISO 7 manufacturing facility, Nutcracker Therapeutics will significantly increase production capacity to more than 2,000 patient-specific therapeutics annually.
NMU-Symphony™ introduces major hardware and software updates for the efficient and rapid manufacture of PCTs or other clinical-grade RNA therapeutics. Among the improvements is a redesign and release of its microfluidic biochips to efficiently manufacture RNA drug products. The manufacturing system utilizes the company’s proprietary ProcessVisionTM technology, enabling more than twenty on-system measurements that verify system performance and quality in real time.
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NMU biochips produce quantities scaling from 1 to 200 mg, perfectly suited for PCTs, and are scalable to produce larger quantities. The company has successfully completed drug substance manufacturing under GMP conditions, demonstrating process times consistent with a less than four-day on-system process time, and a three-week overall turnaround time, from RNA sequence design to released nanoparticle formulated drug product.
“Our mission is to bring scalable, low cost, and rapid RNA manufacturing to the forefront of individualized therapeutic development,” said Benjamin Eldridge, co-founder and chief technology officer of Nutcracker Therapeutics. “With the NMU-Symphony™ platform and our GMP-ready infrastructure, we’re now enabling faster, higher-quality production of personalized RNA medicines for our industry partners.”
SOURCE: Businesswire