The designation of starting materials (SMs) for pharmaceuticals has been a topic of great interest and debate since the first ICH quality guidance was published. The increase in the number and variety of commercialized oligonucleotides (antisense oligonucleotides—ASOs, small interfering RNAs—siRNAs, etc.) in recent years has reignited dialogue on this topic because of the unique complexity of the monomeric nucleotides and other contributory materials used to manufacture oligonucleotides. The SM working group in the European Pharma Oligonucleotide Consortium (EPOC) was formed to help establish simple, risk-based criteria to guide the justification of oligonucleotide SMs. This article provides a description of the common types of SMs, classes of SM impurities, and control strategies that will be helpful to maintain manufacturing consistency.

中文翻译：

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对寡核苷酸起始材料指定的看法

自从第一个 ICH 质量指南发布以来，药物起始材料 (SM) 的指定一直是一个引起极大兴趣和争论的话题。近年来商业化寡核苷酸（反义寡核苷酸——ASO、小干扰 RNA——siRNA 等）数量和种类的增加重新点燃了关于这个话题的对话，因为用于制造的单体核苷酸和其他贡献材料的独特复杂性寡核苷酸。欧洲制药寡核苷酸联盟 (EPOC) 的 SM 工作组旨在帮助建立简单、基于风险的标准，以指导寡核苷酸 SM 的合理性。本文描述了 SM 的常见类型、SM 杂质的类别以及有助于保持制造一致性的控制策略。