ANALYTICAL/QUALITY ARTICLES

ANALYTICAL/QUALITY VIDEOS

Though there are a lot of exciting advancements being made with novel lipid chemistries, CMC Consultant Sujit Jain provides an important reality check for us: These innovations break established platforms, requiring fresh process development, complex impurity profiling, and new vendor qualifications.

Here, we describe the use of cutting-edge technologies to assess critical quality attributes of both mRNA drug substances and drug products.

In this Advancing RNA Live segment, several speakers raise concerns about the industry's ability to accurately measure impurities, particularly dsRNA, arguing that current analytics are insufficient, especially for high-dose therapeutics.

Explore the behind-the-scenes best practices of the company implemented that led to the approval of the world’s first saRNA vaccine in Japan.

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS