Stabilization of mRNA Lipid Nanoparticules

Stability studies
Categories
Drug product
Assays
Active Immunization Countermeasures

Industry Need

mRNA-LNP vaccines currently require ultra-cold storage (-80 °C), creating high costs and logistical challenges for manufacturers and distributors. This dependency on cold chain infrastructure limits global access and increases waste risk. Industry needs stabilization technologies that maintain potency at refrigerated or ambient conditions to reduce cold chain reliance, lower costs, and enable broader market reach.

Approach

CU Boulder explored two innovative stabilization approaches:

  • Spray Drying: Formulated mRNA-LNPs with excipients (25% trehalose, hydroxyethyl starch, F-68, histidine, methionine) and converted them into dry powders.
  • Atomic Layer Deposition (ALD): Applied nanoscopic alumina coatings to spray-dried mRNA-LNP microparticles using fluidized bed reactors. Both methods aimed to improve shelf life and reduce cold chain dependency.
  • CU Boulder prepared and shipped stabilized samples to KU VAFC for centralized analysis and conducted 90-day stability studies at -80 °C, 4 °C, and 30 °C.


Value Statement/Outcomes

Spray-dried mRNA-LNP formulations maintained ~90% intact mRNA and stable lipid profiles for 90 days at up to 30 °C, while ALD-coated samples showed stability over time. These findings suggest potential cold-chain cost savings and improved long-term storage options.

Outputs/Deliverables

Developed and optimized spray-dried and ALD-coated mRNA-LNP formulations.

Prepared and shipped stabilized samples to KU VAFC for centralized stability testing.

Generated comparative data on mRNA integrity, encapsulation efficiency, lipid integrity, particle size, and turbidity.

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Project Lead

Regents of the University of Colorado (Boulder)

Regents of the University of Colorado (Boulder)