Oligonucleotide modalities are diversifying and impurity profiles are changing at the same rate, depending on chemistry and synthesis route.

With regulatory scrutiny intensifying and oligonucleotide therapies advancing toward late-stage development, this workshop is designed for teams to not only detect impurities but accurately characterize their structure, origin, and potential impact on product quality.

Join three leading industry experts across oligonucleotide platforms to overcome persistent challenges and build regulatory ready impurity control strategies at scale.

Key Questions to be Addressed:

• How reliably can emerging analytical strategies detect and characterize low‑level or novel impurities?
• How to leverage understanding the chemical origins of oligonucleotide impurities to strengthen early-stage control strategy?
• How dose, duration, chemical modifications, conjugation type, and biotransformation pathways influence impurity criticality, especially in light of EMA’s 2024 draft guideline?