Advanced therapies based on genes, tissues, or cells offer ground breaking new opportunities to treat incurable diseases. Within these therapies, mRNA offers some unique advantages over other modalities, such as DNA, viral vectors, or recombinant proteins.
mRNA manufacture is a cell-free process that reduces the production timeline and makes it relatively simple to produce. This promise of an effective, fast, and revolutionary treatment has increased the demand for mRNA production while adding emphasis on streamlining the manufacturing process of new products.
Although product manufacture and process validation of biotherapeutics are performed routinely in the industry, the process for mRNA manufacture is less well established and there are several variations between manufacturers.
This paper gives an overview of the mRNA/lipid nanoparticles manufacturing unit operations for drug substance/drug product. It was developed by CGT experts in the RNA workstream of BioPhorum Cell and Gene Therapy to enable future discussions and accelerate the commercialization of mRNA therapies.