mRNA: Removing Bottlenecks in Process Development and Manufacturing
Event: mRNA-Based Therapeutics Summit Europe
Date: January 2022
Presenter: Rok Sekirnik, Head of Process development for mRNA and pDNA
In vitro-transcribed messenger RNA-based therapeutics represent a relatively novel and highly efficient class of drugs. Current clinical efforts encompassing mRNA – based drugs are directed to three categories: mRNA vaccine, mRNA therapy and protein replacement therapy. As mRNA vaccine became the front runner to fight the COVID-19 pandemic, challenges surrounding their process development and manufacturing became readily apparent:
- mRNA manufacturing is not yet a platform approach. Standardized products along the processes are needed
- mRNA is a relatively large molecule, which leads more challenges for downstream purification.
- mRNA is intrinsically unstable and prone to degradation.
- High raw material cost is limiting mRNA commercialization.
This presentation provides a detailed overview of current mRNA manufacturing approaches, highlights challenges and recent successes, and offers perspectives on the future of mRNA manufacturing.