Optimize mRNA Manufacturing: Considerations When Developing Robust Processes In A cGMP Environment

By Clemens Jakobi, Commercial Senior Director, Michal Domański, MSAT Lead mRNA Development, and Telmo Graça, Head of mRNA Process Development

Messenger RNAs (mRNAs) represent a fast-emerging class of biotherapeutics. They hold considerable promise, offering new opportunities for targeted treatment and flexible manufacturing, as demonstrated by the rapid development of mRNA-based COVID-19 vaccines [1,2]. However, the field is still in its infancy, and the clinical potential of mRNA extends beyond vaccines. To date, there have been more than 330 clinical studies [3] involving mRNA as an active ingredient. Lonza has built considerable expertise in the production of mRNA, as both drug substance (DS) and drug product (DP) [4,5].

In this poster, we highlight mRNA production technology aspects, in particularly when considering commercial production and the validation of processes in a cGMP environment.