The NISTmAb Reference Material (RM) 8671 is intended to be an industry standard monoclonal antibody for pre-competitive harmonization of best practices and designing next generation characterization technologies for identity, quality, and stability testing. It must therefore embody the quality and characteristics of a typical biopharmaceutical product and be available long-term in a stable format with consistent product quality attributes. A stratified sampling and analysis plan using a series of qualified analytical and biophysical methods is described that assures RM 8671 meets these criteria. Results for the first three lots of RM 8671 highlight the consistency of material attributes with respect to size, charge, and identity. RM 8671 was verified to be homogeneous both within and between vialing lots, demonstrating the robustness of the lifecycle management plan. It was analyzed in concert with the in-house primary sample 8670 (PS 8670) to provide a historical link to this seminal material. RM 8671 was verified to be fit for its intended purpose as a technology innovation tool, external system suitability control, and cross-industry harmonization platform.

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NISTmAb参考材料（RM）8671旨在成为行业标准的单克隆抗体，用于在竞争前对最佳实践进行协调，并设计用于鉴定，质量和稳定性测试的下一代表征技术。因此，它必须体现典型生物制药产品的质量和特性，并且必须以稳定的格式长期稳定地获得，并具有一致的产品质量属性。描述了使用一系列合格的分析和生物物理方法进行的分层抽样和分析计划，以确保RM 8671满足这些标准。RM 8671的前三个批次的结果强调了材料属性在大小，电荷和身份方面的一致性。验证RM 8671在小批量批内和批批之间是均质的，展示了生命周期管理计划的稳健性。与内部主要样本8670（PS 8670）一起进行了分析，以提供与该原始资料的历史联系。RM 8671经过验证，非常适合作为技术创新工具，外部系统适用性控制和跨行业协调平台的预期用途。

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