2025-2030 Focus: • Establish and refine USP–NF standards for therapeutic oligonucleotides (antisense, siRNA, saRNA, aptamers). • Advance public quality standards addressing the unique structural, synthetic, and analytical complexity of oligonucleotides. • Support development and revision of general chapters and monographs relevant to oligonucleotide drug substances and drug products. • Support alignment of USP requirements with regulatory expectations for CMC, ANDA/NDA comparability, and lifecycle management of oligonucleotide‑based medicines. 2025-2030 Key Issues • Identity and structural characterization • Control of stereochemistry (e.g., phosphorothioate chirality) • Analytical methodology • Reference standards • Specification setting • Comparability and lifecycle management • Safety‑related quality attributes • Elemental impurities, residual solvents, endotoxins (as applicable) • Harmonization challenges Required Expertise Core competencies essential per USP requirements and expert body needs. • Oligonucleotide chemistry • Structural and physicochemical characterization • Impurity and degradation analysis • Compendial science • CMC and quality standards • Specification and control strategy development • Regulatory‑pharmacopeial interface