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. However, the field is still in its infancy, and the clinical potential of mRNA extends beyond vaccines. To date, there have been more than 348 clinical studies involving mRNA as an active ingredient or an enabler for cell and gene therapies such as CRISPR-Cas9 derived therapeutics.
Lonza has built considerable expertise in the production of mRNA, as both drug substance (DS) and drug product (DP). In this article, we discuss the benefits of using mRNA for vaccines and therapeutics while reviewing current and emerging mRNA production technologies. We will address some technical, intellectual property (IP) and cost considerations a biopharma company will have to deal with, particularly when considering commercial production. Additionally, we will illustrate how partnering with Lonza in the early clinical stages may help to access a reliable production workflow.
Authors:
- Michal Domański, MSAT Lead mRNA Development
- Telmo Graça, Head of mRNA Process Development