Nanoparticle mRNA Therapeutics has been the focus of intense research driven by the safety profile and several clinical breakthroughs. As of March 2024, there are two mRNA vaccines approved and many are in active clinical trials. The expected increase in demand for specific Nanoparticle mRNA therapeutics still poses many challenges. The current talk tries to summarize the key aspects related to Research and development needs and Chemistry, Manufacturing and Control (CMC) efforts to help this growing demand. We will primarily discuss applying the different orthogonal methods to identify, monitor and control Critical Quality Attributes (CQAs) during the process development and manufacturing process.

Learning Objectives: 

1. Review different analytical techniques for mRNA therapeutics.

2. Summarize the unique challenges in finding the Critical Quality Attributes (CQAs) for mRNA therapeutics.

3. Demonstrate knowledge about regulatory guidance around lipid nanoparticle analytical characterization.