Regulatory Strategies for Developing and Manufacturing RNA-LNPs

The article touches on: 

⚪ Lipid Selection and Classification (Drug Product)

⚪ RNA Impurities and Classification (Drug Substance)

⚪ mRNA-LNP Physical Characterization Requirements

⚪ Varying Regulatory Authority Expectations

One of the purposes of this article was to bring together developers and manufacturers from the #US, #EU, and #China to share their insights about what they are seeing from their respective Regulatory Authorities (FDA, European Medicines Agency, and NMPA-National Medical Products Administration). This resulted in bringing 3 CRDMOs together to discuss the development and characterization challenges associated with RNA-LNP products.

To access the full article, follow the link below:

Nucleic Acid Insights 2024; 1(3), 139–145

DOI: 10.18609/nai.2024.019