| Title: |
Correlating Stability-Indicating Biochemical and Biophysical Characteristics with In Vitro Cell Potency in mRNA LNP Vaccine |
| Authors: |
Xin Tong; Jessica Raffaele; Katrina Feller; Geethanjali Dornadula; James Devlin; David Boyd; John W. Loughney; Jon Shanter; Richard R. Rustandi |
| Source: |
Vaccines ; Volume 12 ; Issue 2 ; Pages: 169 |
| Publisher Information: |
Multidisciplinary Digital Publishing Institute |
| Publication Year: |
2024 |
| Collection: |
MDPI Open Access Publishing |
| Subject Terms: |
mRNA vaccines; lipid nanoparticles; potency; stability |
| Description: |
The development of mRNA vaccines has increased rapidly since the COVID-19 pandemic. As one of the critical attributes, understanding mRNA lipid nanoparticle (LNP) stability is critical in the vaccine product development. However, the correlation between LNPs’ physiochemical characteristics and their potency still remains unclear. The lack of regulatory guidance on the specifications for mRNA LNPs is also partially due to this underexplored relationship. In this study, we performed a three-month stability study of heat-stressed mRNA LNP samples. The mRNA LNP samples were analyzed for their mRNA degradation, LNP particle sizes, and mRNA encapsulation efficiency. In vitro cell potency was also evaluated and correlated with these above-mentioned physiochemical characterizations. The mRNA degradation–cell potency correlation data showed two distinct regions, indicating a critical cut-off size limit for mRNA degradation. The same temperature dependence was also observed in the LNP size–cell potency correlation. |
| Document Type: |
text |
| File Description: |
application/pdf |
| Language: |
English |
| Relation: |
Nucleic Acid (DNA and mRNA) Vaccines; https://dx.doi.org/10.3390/vaccines12020169 |
| DOI: |
10.3390/vaccines12020169 |
| Availability: |
https://doi.org/10.3390/vaccines12020169 |
| Rights: |
https://creativecommons.org/licenses/by/4.0/ |
| Accession Number: |
edsbas.8341E7BE |
| Database: |
BASE |