Strategies For Producing Clinical And Commercial RNA-LNP Drug Products

The lipid nanoparticle (LNP) delivery technology underlying the prophylactic messenger RNA (mRNA) vaccines against SARS-CoV-2 infection has been clinically validated. This success is now driving interest in LNP-mediated delivery across a diverse range of new therapeutic approaches and targets. The RNA-LNP therapeutic market is expected to more than double by 2036 due to a healthy pipeline of new therapies. Despite this momentum, developing RNA-based vaccines and therapeutics still faces significant manufacturing challenges. First, RNA-LNP instrumentation must produce the same drug product at both the discovery and the commercial scales. Second, the manufacturing process upstream and downstream of the preparation of the RNA-LNP needs to be designed and de-risked to minimize process development time and accelerate timelines. Third and finally, the manufacturing process needs to be compliant with increasing regulatory requirements. In this application note, we discuss strategies for how NxGen™ mixing can solve these three key challenges.