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

Objectives:

• 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