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  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.
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