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.
This workshop will address the following questions:
- What are the construct-dependent factors that influence dsRNA formation in mRNA therapeutics, and can they be managed?
- What is the current regulatory perspective, specifications and opinion on surrogate standards for dsRNA quantification and control?
- What is known of the tolerability thresholds for dsRNA concerning immunogenicity, and how do they impact therapeutic safety?
- What are the latest analytical advancements in sensitive detection methods for dsRNA?
- What is the perspective on accurately ranking dsRNA fragment and length populations regarding their immunogenicity impact?
