8:00 am Morning Coffee & Registration
Bridging the Gap to Purification Prevention: Advancing Upstream Process Execution to Ensure RNA Purity from the Outset & Eliminate the Need for Purification
9:00 am Reviewing the Relationship between DNA Starting Materials & IVT Fidelity to Build RNA Purity From the Beginning
9:30 am Roundtable Discussion: Defining Upstream Material Specs in Line with Analytics to Minimize Impurity Risk and Strengthen Process Control
10:30 am A Roadmap to Better Designer Polymerase Enzymes: Decoding IVT Reaction Kinetics to Define Optimal Mutant Polymerases That Minimize DSRNA Formation & Preserve Yield
11:00 am Morning Break
Evaluating Novel Purification Methods to Reduce Number of Downstream Steps & Build More Robust & Reproducible Purification Processes at Scale
12:00 pm Optimizing Next-Gen Membrane-Based affinity Purification to Enhance Resolution & Reduce Process Complexity
12:30 pm Innovating mRNA Purification: Overcoming Preclinical Bottlenecks to Enable Scalable, Regulatory-Grade Manufacturing
Synopsis
- Lessons learned from developing purification workflows for both mRNA and DNA in the preclinical setting
- Novel purification approaches to minimize dsRNA, protein, and residual impurity burden
- Strategies to improve yield and reproducibility while reducing reliance on high-cost chromatographic steps
- Considerations for bridging preclinical purification methods with scalable, regulatory-compliant processes for late-stage development