mRNA/saRNA Manufacturing: Considerations To Accelerate The Path To Clinic

Messenger RNA (mRNA) and self-amplifying RNA (saRNA) unravel new possibilities for the treatment and prevention of diseases. As relatively new therapeutic modalities, both offer advantages: they can instruct the ribosome to make almost any protein, function without entering the cell nucleus, and degrade without leaving behind unwanted or harmful genetic traces. With some of the recent advances in mRNA and saRNA process technologies, we are beginning to realize the true potential of these modalities. Interestingly, saRNA also has the added advantage of lower doses compared to mRNA while getting the same effect (50-100-fold lower in some instances). However, the success of the mRNA/saRNA programs and the path to the clinic depend heavily on the timeline of manufacturing the RNA molecules.

In this webinar, Dr. Venkata Indurthi discusses some of the key upstream and downstream considerations that go into process development for RNA drug substance manufacturing. Moreover, Dr. Indurthi also presents data on the parameters that need construct-specific optimization to increase yield and reduce impurities, in addition to sharing his insights on critical aspects of analytical development to accelerate the path to the clinic.

A Q&A session follows the presentation.