Cytiva, a global life sciences company, has launched the NanoAssemblr commercial formulation system, purpose-built for clinical and commercial manufacturing of lipid nanoparticle medicines. The NanoAssemblr is fully compliant and offers automated instrumentation using a single, scalable mixing technology for all stages of development, from research to product development to large-scale manufacturing.
 
The system builds on Cytiva’s NxGen technology, which produces controlled and reproducible mixing conditions during lipid nanoparticle (LNP) formulation to help 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 cGMP conditions.
 
The single-use formulation system for clinical and commercial production, is designed to minimize the risk of cross-contamination, which is particularly important for genomic medicines. The single-use fluid path also helps boost production by minimizing downtime for sanitizing and performing cleaning validation efficient changeovers. This makes it possible to manufacture multiple lipid nanoparticle products within the same facility.
 
It is powered by software that is 21 CFR Part 11 compliant, and enables electronic batch records that capture in-process monitoring of flow rate and automates the priming, calibrating, formulating and in-line dilution processes.
 
Emmanuel Abate, President, Genomic Medicine, Cytiva said, “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.”
 
The NanoAssemblr commercial formulation system is expected to be available to customers in 1Q24.