GEN webinar featuring Dr. Venkata Indurthi, Aldevron Chief Scientific Officer
Messenger RNA (mRNA) and self-amplifying RNA (saRNA) offer a unique opportunity for the development of novel therapeutics to treat a wide range of diseases. These modalities offer distinctive advantages over traditional therapies, from both biological and production standpoints. The success of RNA programs may depend heavily on the timeline to manufacture RNA molecules.
While it may seem counterintuitive, spending more time in process development may accelerate the path to clinic. To help streamline process development for mRNA/saRNA manufacturing, Dr. Venkata Indurthi highlighted several considerations to keep in mind.
One such consideration, construct-specific optimization, reduces the load on downstream manufacturing. “The fewer downstream unit operations you have, the better off the RNA process,” he said. “You get much higher recoveries.”
Indurthi touched on how optimization at each step of the manufacturing process can impact critical project parameters, such as purity, yield, and activity. Other subjects include the role of modified nucleotides and the type of capping technologies, which Indurthi deemed the “most critical” consideration.
Indurthi also discussed the importance of well-established release specifications, which can help decrease impurities and prevent product failure. With so many things to consider, however, he also stressed that there are multiple solutions to arrive at the highest possible purity and activity levels for your product.
“You need not be married to one over the other,” he said. “Irrespective of which path you choose, depending on your molecule and the end application, there are ways of achieving the same endpoint.”
After his presentation, Dr. Indurthi fielded several engaging questions from curious scientists about the potential impacts of mRNA and saRNA in biomanufacturing. Tune in to this informative webinar, as well as the discussion afterward, to learn what a thorough PD could mean for your own business’s growth.