Current mRNA-LNP vaccines require ultra-cold storage (-80 °C), creating high costs and logistical complexity for manufacturers and distributors. This dependency on cold chain infrastructure limits global access, particularly in low- and middle-income countries, 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.
VaxForm developed a novel stabilization approach using polymeric microencapsulation combined with aluminum phosphate adjuvant to protect mRNA-LNP formulations. Key steps:
VaxForm’s lead formulation maintained near 100% transfection efficiency at 4 °C and -80 °C for 90 days versus baseline LNP dropping to ~55% at 4 °C, and achieved 147% relative potency at -80 °C. At 30 °C, both control and VaxForm FDP degraded to ~30% efficiency after 2 weeks, but VaxForm showed better early stability. This approach could yield significant cold-chain cost savings and enable dose-sparing benefits.
Developed and optimized polymeric microencapsulation stabilization platform for mRNA-LNP.
Identified lead formulation (F6) and validated stability at -80 °C and 4 °C for 90 days.
Demonstrated enhanced transfection efficiency and broader T-cell response in PBMC assays.
Delivered 40 tubes of lead formulation to KU VAFC for centralized stability testing.
Generated comparative data on mRNA integrity, encapsulation efficiency, particle size, and surface charge.
Burlet, E., Presenter, Novel mRNA LNP Vaccine Formulations for Improved Cell Targeting & Thermostability, Presented at Vaccines R & D, Boston, MA, November 12, 2024.
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VaxForm LLC
