单克隆抗体毛细管区带电泳分析程序控制策略：ε-氨基己酸和三乙烯四胺的替代品。

IF 2.5 3区生物学 Q2 BIOCHEMICAL RESEARCH METHODS

ELECTROPHORESIS Pub Date : 2025-09-23 DOI:10.1002/elps.70038

Joanne Baxter, Lori Fitton, Cari E S van de Griend

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引用次数: 0

摘要

关于分析程序制定的ICH指南Q14强调了以科学和基于风险的方法评价药品质量的重要性。最终，制药公司（发起人）负责确保分析方法在其整个生命周期的日常使用中符合目的。分析程序控制策略的一部分是负责确保分析方法的关键材料的可用性。对于毛细管区带电泳（CZE）方法来说，背景电解质（BGE）组成是一个关键和关键的材料。在本研究中，我们研究了ε-氨基己酸（eACA） CZE （eACA-CZE）单克隆抗体方法的关键成分是否可以被结构相关的化学物质取代。比较了复杂的非均质性模式，并报告了主峰、酸性峰和碱性峰的百分比。总的来说，这些结果强调了eACA- cze方法的坚固性，并在出现质量或供应问题的情况下提供了eACA和三乙基毒胺（TETA）的替代选择，从而降低了风险，并保障了治疗性单克隆抗体的释放和稳定性研究。

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Towards an Analytical Procedure Control Strategy for the Capillary Zone Electrophoresis Method for Monoclonal Antibodies: Alternatives for ε-Aminocaproic Acid and Triethylenetetramine.

The ICH guideline Q14 on analytical procedure development underlines the importance of science and risk-based methods for the evaluation of the quality of medicines. Ultimately, a pharmaceutical company, the sponsor, is responsible that the analytical method is fit-for-purpose during routine use throughout its lifecycle. Part of the analytical procedure control strategy is the responsibility to assure availability of critical materials of the analytical method. For capillary zone electrophoresis (CZE) methods, the background electrolyte (BGE) composition is a key and critical material. In this study, we investigated whether key ingredients of the ε-aminocaproic acid (eACA) CZE (eACA-CZE) method for monoclonal antibodies can be replaced by structurally related chemicals. The complex heterogeneity patterns are compared, as well as the reportable results as the percentage main, acidic and basic peaks. Overall, the results underline the ruggedness of the eACA-CZE method and provide alternative options to eACA and triethyltetramine (TETA), in case there are quality or supply issues, thus de-risking and safeguarding release and stability studies for therapeutic mAbs.

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来源期刊

ELECTROPHORESIS 生物-分析化学

CiteScore

6.30

自引率

13.80%

发文量

244

审稿时长

1.9 months

期刊介绍： ELECTROPHORESIS is an international journal that publishes original manuscripts on all aspects of electrophoresis, and liquid phase separations (e.g., HPLC, micro- and nano-LC, UHPLC, micro- and nano-fluidics, liquid-phase micro-extractions, etc.). Topics include new or improved analytical and preparative methods, sample preparation, development of theory, and innovative applications of electrophoretic and liquid phase separations methods in the study of nucleic acids, proteins, carbohydrates natural products, pharmaceuticals, food analysis, environmental species and other compounds of importance to the life sciences. Papers in the areas of microfluidics and proteomics, which are not limited to electrophoresis-based methods, will also be accepted for publication. Contributions focused on hyphenated and omics techniques are also of interest. Proteomics is within the scope, if related to its fundamentals and new technical approaches. Proteomics applications are only considered in particular cases. Papers describing the application of standard electrophoretic methods will not be considered. Papers on nanoanalysis intended for publication in ELECTROPHORESIS should focus on one or more of the following topics: • Nanoscale electrokinetics and phenomena related to electric double layer and/or confinement in nano-sized geometry • Single cell and subcellular analysis • Nanosensors and ultrasensitive detection aspects (e.g., involving quantum dots, "nanoelectrodes" or nanospray MS) • Nanoscale/nanopore DNA sequencing (next generation sequencing) • Micro- and nanoscale sample preparation • Nanoparticles and cells analyses by dielectrophoresis • Separation-based analysis using nanoparticles, nanotubes and nanowires.