Formulation Strategies and Stability Characterization of siRNA Drug Products

Oligonucleotides in general and small interfering RNAs (siRNAs) in particular are becoming one of the fastest growing therapeutic modalities in the current age. With four FDA approved siRNA-based drugs (patisiran, givosiran, lumasiran and inclisiran) and several lined up in late stage clinical trials, this modality is becoming an essential and reliable tool for gene silencing. The progress and success of approval of siRNA therapeutics heavily depend on overcoming some of the challenges such as limited stability, off-target binding, unfavorable physicochemical properties etc. This talk is designed to highlight formulation strategies and stability studies for siRNA drug products to support manufacturability and shelf-life.

Sathya Venkataramani, Director Pre-Pivotal Drug Product Technologies - Biologics, Amgen