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Cytiva Launches System To Enable End-to-End Manufacturing of Lipid Nanoparticle Medicines

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Cytiva has launched the NanoAssemblr commercial formulation system, purpose-built for clinical and commercial manufacturing of lipid nanoparticle medicines. Fully compliant and offering automated instrumentation, the NanoAssemblr commercial formulation system can be used by companies to bring these medicines to market using a single, scalable mixing technology for all stages of development, from research to product development to large-scale manufacturing.

Emmanuel Abate, President, Genomic Medicine, Cytiva says: “There’s a large and very exciting pipeline of nanoparticle-based medicines across the areas of gene therapy, protein replacement, oncology indications including the highly promising and exciting cancer vaccines, as well as the vital infectious disease vaccines. One of the challenges today is how to achieve reproducibility and scalability to take these formulations to market. Our NanoAssemblr commercial formulation system provides the end-to-end capability that will help accelerate the process.”

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The NanoAssemblr commercial formulation system builds on Cytiva’s NxGen technology, which produces controlled and reproducible mixing conditions during lipid nanoparticle (LNP) formulation, which helps ensure consistent quality attributes throughout development and scale-up. NxGen technology maintains the same mixing architecture from the NanoAssemblr Ignite and Blaze (preclinical platforms for the development of genomic medicines) during the early research and product development stages to the NanoAssemblr commercial formulation system for large-scale manufacturing under current Good Manufacturing Practices (cGMP) conditions.

Abate says: “No one else offers this continuum. By providing the same, consistent NxGen technology from preclinical research to commercial production, we provide users with ease of scaling."

As the first single-use formulation system for clinical and commercial production, the NanoAssemblr commercial formulation system minimizes the risk of cross-contamination, which is particularly important for genomic medicines. The single-use fluid path also helps companies boost production by minimizing downtime for sanitizing and performing cleaning validation and by enabling efficient changeovers. This makes it possible to manufacture multiple lipid nanoparticle products within the same facility.

Powered by intuitive software that is compliant with 21 CFR Part 11 (Code of Federal Regulations: Title 21: Part 11), the system enables electronic batch records that capture in-process monitoring of flow rate and automates the priming, calibrating, formulating and in-line dilution processes.

Scott Ripley, Nucleic Acid Therapeutics and Precision NanoSystems (PNI) leader, Cytiva, says: “Companies previously had to go to two or three different providers to build an end-to-end workflow for the clinical development and commercial production of lipid nanoparticle medicines. With our NanoAssemblr commercial formulation system, they can now build it under one project-managed workflow.”