Unlocking Efficient Oligonucleotide Manufacturing in Line with Regulatory Expectations
Time: 3:00 pm
day: Pre-Conference Day
Details:
With RNA editing evolving as the next frontier therapeutic modality, many hurdles need Workshop Leaders: to be crossed to ensure the RNA molecules are synthesized correctly, efficiently and at scale. This puts CMC strategies and cGMP manufacturing at the heart of the challenges to be addressed before upscaling manufacturing and ensuring it is in line with regulatory expectations:
This workshop will tap into:
- Optimizing CMC methods for rapid RNA process development and upscale
- Controlling the manufacturing process to de-risk failures
- Defining the specific techniques to employ for oligos to improve product yields
- Unraveling the pathway for translatability from small to large scale manufacturing, highlighting regulatory expectations
