Advancing analytics in oligonucleotide therapeutics: innovations, challenges, and regulatory insights

“Many conditions that are currently considered undruggable may soon become druggable. I believe we are entering a new era of nucleic acid medicines.”Oligonucleotide therapeutics present unique analytical obstacles due to their structural complexity, stereochemical diversity, and impurity profiles that are difficult to fully characterize with current tools.Nucleic Acid Insights assembled a panel of leading experts, including Afaf El-Sagheer, (Assistant Professor, University of Southampton), Mike Webb (Independent Consultant, Mike Webb Pharma), and Thomas Minshull (Postdoctoral Researcher, University of Sheffield), to discuss the key analytical challenges facing the field, strategies for impurity characterization, and considerations for safety, comparability, and regulatory acceptance. The article also highlights future opportunities to advance the field, including the application of AI, structural biology, and cross-sector collaborative research.