Fireside chat: advancing analytical science and regulatory readiness for nucleic acid medicines

“LC-MS of oligonucleotides has advanced considerably and is approaching a level of maturity where more routine use outside R&D settings should be feasible.”

Jonathan Neidigh (CMC Consultant) and Michael Bartlett (Professor, University of Georgia) discuss the analytical and regulatory challenges facing the field, exploring key gaps in impurity characterization and method development, the limitations of current chromatographic platforms in quality control settings, and the value of closer collaboration between academic and industry scientists.

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