8:00 am Check-In
9:00 am Workshop A: Analytical Development Techniques and Challenges for Highly Modified Oligonucleotides
Synopsis
This workshop will explore advanced analytical methods and considerations for addressing the unique challenges posed by complex oligonucleotide subtypes. With a focus on overcoming hurdles in their analytical development, with specificity to analytics of quantification, characterization, impurity profiling, and complex delivery routes.
Highlights of this workshop include:
- Deep dive into analytics for oligos and oligoconjugates including quantification, characterization, and impurity profiling
- Discussions of analytical techniques supporting phosphonodiamidite morpholino oligonucleotide and oligonucleotide-conjugate manufacturing
- Modifications to regulatory submission packages for these novel or complex oligo modalities
- Overcoming challenges in analytics for complex delivery methods such as LNPs and targeting to specific tissues