Overcoming the Longstanding Challenges in the Characterization & Control of dsRNA to Develop Safer & Regulatory-Compliant mRNA Therapeutics
Time: 8:35 am
day: Pre-Conference Workshop Day
Details:
dsRNA presents a significant, persistent and debated challenge in the development of safe and effective mRNA medicines. The construct-dependent nature of dsRNA formation complicates efforts to standardize production and quality control, as the absence of a standardized sensitive detection and surrogate standard hinders the establishment of universally accepted guidelines for dsRNA levels. The immunogenicity of dsRNA raises concerns about tolerability, making it crucial to determine acceptable levels, fragments and lengths of dsRNA for release. This workshop aims to address these pain points and regulatory perspectives alongside
recent strides in the field to develop more sensitive detection methods and progress the ranking of dsRNA fragments and populations to better predict and control their impact on therapeutic outcomes.
