mRNA applications – From vial to prefilled syringe
COVID-19 has brought the mRNA era into existence. Biotechs that have been working on the technology for years are now ready for liftoff, with vaccines and therapeutics for a range of diseases from flu to cystic fibrosis. But the technology comes with storage and transport limitations driven by the fragility of the lipid nanoparticles (LNPs) that function as mRNA delivery systems. Deep cold temperature conditions and consecutive, unpredictable free-thaw cycles may impact the functional performance, mechanical stability, container closure integrity, sterility and particulate levels of the drug container. These risks raise important questions about the safety of different primary packaging formats, and must be fully understood to launch mRNA drugs with confidence.
In this session, we will discuss test data for syriQ® glass syringes, demonstrating robust performance down to -50°C and highlighting the importance of complex component and materials interaction in the pre-filled syringe system. Our results confirm the suitability of syriQ® glass pre-filled syringes as a primary packaging solution for mRNA and other applications requiring cold storage down to -50°C. This allows drug manufacturers to exploit the benefits that come with glass of established manufacturing networks, multiple supply sources, and a clear regulatory path.