Introduction:
This article discusses the challenges associated with manufacturing messenger RNA (mRNA) at scale and proposes digital process optimization as a potential solution. The researchers from the Institute for Separation and Process Technology at Clausthal University of Technology in Germany focused on in vitro transcription (IVT), a process where mRNA molecules are formed from nucleotide building blocks. The current IVT methods have limitations in maintaining nucleotide concentrations for longer commercial processes and result in the formation of truncated mRNA molecules.
- The current IVT methods have limitations in maintaining nucleotide concentrations for longer commercial processes, leading to the formation of truncated mRNA molecules.
- Firms like Moderna and BioNTech have developed fed-batch IVT processes to address these limitations, but their wider commercial use has been limited.
- The researchers developed a digital model to optimize IVT and maximize mRNA yields by determining the optimal reagent concentrations and reaction conditions.
- Their approach resulted in producing 55% more mRNA with 33% less truncated mRNA compared to the initial starting point.
- The researchers suggest that their optimized IVT process could be the basis for a fully continuous and efficient manufacturing process for mRNA and other cell and gene therapy drugs or vaccine candidates.
Conclusion:
The researchers at Clausthal University of Technology in Germany have proposed a digital model to optimize the in vitro transcription (IVT) process for manufacturing messenger RNA (mRNA). By determining the optimal reagent concentrations and reaction conditions, they were able to significantly increase mRNA yields and reduce the formation of truncated mRNA molecules. This optimized IVT process could be a valuable solution for manufacturing mRNA and other cell and gene therapy drugs or vaccine candidates. Further development and implementation of such digital in vitro transcription models could aid in the scale-up of mRNA production and address the challenges faced by manufacturers in this field.
