Manufacturing of long RNA oligos: Synthesis and analytical strategies and challenges
26 Jun 2025
CMC & Process Development
- Navigating evolving requirements in the US and Europe, including release testing, characterization, and impurity profiling
- Addressing challenges in method qualification, mass spec limitations, and developing robust analytical strategies for regulatory compliance
- How the field is evolving, the impact on gene editing and major pharma, and ensuring all stakeholders align with regulatory expectations