An oenophiles dilemma: standing in the wine store choosing between a French cabernet in one hand and California cabernet in the other—and enough money for only one. Pharmaceutical API developers often face a similar, albeit less delicious, quandary when deciding which manufacturers products will provide them the most optimal results. For instance, since messenger RNA (mRNA) therapeutics have been on the rise in recent years, biomanufacturers are scrambling to optimize their production workflows and are often at a loss deciding which reagents and raw materials will allow them to create and deliver the most efficacious synthetic mRNA. And while this has become a bourgeoning area of biotechnology, the novelty of mRNAs as therapeutic agents entails uncertainties for their introduction to market—making a seamless transition from development to manufacturing a key factor toward success.
In this GEN webinar, we will discuss the use and optimization of reagents employed for in vitro mRNA synthesis—highlighting the notion that raw material choices and small changes can lead to better quality outcomes. Because delivery of the therapeutic message can only happen after the appropriate regulatory review, our panelists will discuss the important technical and regulatory factors that need to be considered when selecting and using raw material for therapeutic mRNA production.