Formulation & Process Development of Targeted LNPs for In Vivo T Cell & Hematopoietic Stem Cells Editing
- Establishing robust process characterization strategies for LNP formulation and fill-finish operations to enable consistent product quality through Phase II/III and commercial manufacturing
- Sharing approaches to scale microfluidic mixing and downstream purification workflows while maintaining critical quality attributes including particle size, encapsulation efficiency, and potency
- Aligning analytical methods, comparability packages, and control strategies with evolving global regulatory expectations for commercial mRNA therapeutics and vaccines