MANUFACTURING ARTICLES

MANUFACTURING VIDEOS

In this Advancing RNA Live clip, Sanofi’s Sumit Luthra highlights the learnings we’ve made to-date about how our processes — both in terms of unit operations and process conditions — inform our LNP composition/heterogeneity.

Developing a client-sponsored Target Product Profile (TPP) and Analytical Target Profile (ATP) is critical to move your drug product to clinic efficiently and meet acceptance criteria.

As a field, we’ve been aligned around CQAs for our mRNA drug substances. However, differences in translation between highly similar mRNAs (i.e., (same sequence, same design, different manufacturers) raises the question of whether we’re missing any QAs/CQAs. Here, Advancing RNA Live panelists Elaine Peters and Ilya Shestolapov share their take. 

The innovative MYCAP bottle closure system provides more options for aseptic fluid transfer in bottles and rigid containers. The elastomeric closure makes it a truly universal closure system.

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS