ANALYTICAL/QUALITY ARTICLES

ANALYTICAL/QUALITY VIDEOS

Optimize mRNA development by learning key strategies for process refinement, critical component identification, and in-process analytics to enhance therapeutic production.

Companies often underestimate the information required for IND submissions, particularly in a sector that’s as diverse as the mRNA sector. Here, former FDA reviewer Tiffany Lucas shares some of the missteps companies can make when first approaching the FDA with their IND. CureVac’s Ulrike Jägle furthers the discussion, offering a critical best practice she and her colleagues rely upon as well to streamline their regulatory interactions.

Explore why process-related impurities are a concern in vaccines and present results and learnings from LC-MS analyses of several mRNA- and protein-based vaccines for COVID-19.

In this Advancing RNA clip, panelists Ulrike Jägle and Tiffany Lucas unpack the benefits they see to the MHRA's new guidance on mRNA cancer immunotherapies, including the agency’s support for bioinformatics approaches and its burgeoning framework for developing and justifying a truly personalized medicine.

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