(40f) The Challenge of Cost-Effective, Scalable, and FDA Approvable Nanoparticle Processes and Production

The dramatic implementation of the COVID lipid nanoparticle (LNP) vaccines have demonstrated the ability to produce nanoparticle therapeutics at scale, in a cost-effective manner. Mike McDermott, the President of Pfizer Global Supply, in the CNN interview where he took the press through the Pfizer production process stated: “the impingement jet mixer makes it possible.” The confined impinging jet mixers are the technology developed in our laboratory. We will discuss the basis for the technology. The application of the technology for oral therapeutics will emphasize our work supported by the Bill and Melinda Gates Foundation on drugs for global health. The key question for the future is how will this technology be implemented for other therapeutic classes including high value small molecule drugs and targeted nucleotide therapeutics?