Scale Up And Manufacturing Of Self-Amplifying RNA-LNPs For A COVID-19 Vaccine Using The NanoAssemblr® GMP System



  • To scale up SARS-CoV-2 self-amplifying RNA-Lipid nanoparticle using PNI developed ionizable lipid and formulation from 0.2, to 50 mg scale using PNI’s Manufacturing Platform (Ignite™, Blaze™, GMP NanoAssemblr®)
    • A phase I trial for saRNA Vaccine requires 50 mg scale
  • To optimize the down-stream processing (TFF/Sterile filtration)
    • TFF type, Material, MWCO
    • Processing buffers
    • TFF shear rate
    • TFF scalability
  • To select a lead saRNA-LNP formulation and define a manufacturing process based on formulation activity, stability, scalability, repeatability and critical process parameters
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