Current mRNA-LNP vaccines require ultra-cold storage (-80 °C) to maintain stability, creating significant cost and logistical challenges for global distribution. This dependency on cold chain infrastructure limits access in low- and middle-income countries and increases manufacturing and supply chain complexity for industry. Improving thermostability would reduce cold chain reliance, lower costs, and expand market reach for mRNA vaccines.
PATH evaluated two industry-relevant stabilization technologies—lyophilization (freeze-drying) and spray-drying—to create thermostable mRNA-LNP formulations. The team:
Lyophilization and spray-drying enabled production of dry mRNA-LNP formulations that maintained ≥90% mRNA integrity and stable lipid profiles for 90 days at up to 30 °C, reduce reliance on ultra-cold storage and provide significant cold-chain cost savings.
Developed and optimized lyophilized and spray-dried mRNA-LNP formulations and identified dissolution conditions for reconstitution.
Executed MTA with KU for stability testing under three temperature conditions for 90 days.
Delivered 40 vials each of lead lyophilized and spray-dried formulations (plus empty LNP controls) to KU VAFC.
Generated preliminary data on particle size, turbidity, mRNA integrity, lipid integrity, and encapsulation efficiency.
Generated data on particle size, turbidity, mRNA integrity, lipid integrity, and encapsulation efficiency.
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PATH Center for Vaccines Innovation & Access
