Symposium 2025 Recordings

Hybrid-modeling in mRNA manufacturing process development

Konstantinos Alexias

Abstract

One of the most important and widely used process steps in mRNA drug substance manufacturing is the In Vitro transcription reaction. This process step allows for template-directed synthesis of RNA molecules of any sequence from short oligonucleotides to those of several kilobases long.

Despite its mechanistically straightforward nature, the optimization of the In Vitro transcription reaction for mRNA manufacturing processes can be quite challenging. In view of the ever-growing capabilities of hybrid models in biopharmaceutical process development, a study was conducted to address this optimization challenge by developing a hybrid-model to characterize and sufficiently predict the performance of this process step.