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NISTmAb 参考物质 8671 的赋值、均匀性和稳定性。

The NISTmAb Reference Material 8671 value assignment, homogeneity, and stability.

机构信息

National Institute of Standards and Technology, Institute for Bioscience and Biotechnology Research, 9600 Gudelsky Dr, Rockville, MD, 20850, USA.

, 55 Watkins Mill Rd., Gaithersburg, MD, USA.

出版信息

Anal Bioanal Chem. 2018 Mar;410(8):2127-2139. doi: 10.1007/s00216-017-0800-1. Epub 2018 Feb 7.

DOI:10.1007/s00216-017-0800-1
PMID:29411089
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5830482/
Abstract

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. Graphical abstract 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.

摘要

NISTmAb 参考物质（RM）8671 旨在成为一种行业标准单克隆抗体，用于预竞争最佳实践的协调以及设计下一代用于身份、质量和稳定性测试的表征技术。因此，它必须体现典型生物制药产品的质量和特性，并以稳定的格式长期提供，具有一致的产品质量属性。描述了一种分层抽样和分析计划，使用一系列合格的分析和生物物理方法，以确保 RM 8671 符合这些标准。RM 8671 的前三个批次的结果突出了材料属性在大小、电荷和身份方面的一致性。RM 8671 被证明在瓶内和瓶间都是均匀的，证明了生命周期管理计划的稳健性。它与内部原始样品 8670（PS 8670）一起进行分析，为这种开创性材料提供了历史联系。RM 8671 被验证适合用作技术创新工具、外部系统适用性控制和跨行业协调平台。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a101/5830482/34620a28090e/216_2017_800_Fig10_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a101/5830482/40bf3addef9e/216_2017_800_Figa_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a101/5830482/586ab8771a90/216_2017_800_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a101/5830482/2da3d8848263/216_2017_800_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a101/5830482/2028cf3b84e0/216_2017_800_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a101/5830482/3564aa9e5b85/216_2017_800_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a101/5830482/83d2724eae75/216_2017_800_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a101/5830482/43be5c112042/216_2017_800_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a101/5830482/0bca4bf065c1/216_2017_800_Fig7_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a101/5830482/ee30ce37ccca/216_2017_800_Fig8_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a101/5830482/197807594f3c/216_2017_800_Fig9_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a101/5830482/34620a28090e/216_2017_800_Fig10_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a101/5830482/40bf3addef9e/216_2017_800_Figa_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a101/5830482/586ab8771a90/216_2017_800_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a101/5830482/2da3d8848263/216_2017_800_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a101/5830482/2028cf3b84e0/216_2017_800_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a101/5830482/3564aa9e5b85/216_2017_800_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a101/5830482/83d2724eae75/216_2017_800_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a101/5830482/43be5c112042/216_2017_800_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a101/5830482/0bca4bf065c1/216_2017_800_Fig7_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a101/5830482/ee30ce37ccca/216_2017_800_Fig8_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a101/5830482/197807594f3c/216_2017_800_Fig9_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a101/5830482/34620a28090e/216_2017_800_Fig10_HTML.jpg

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