高级检索

双特异性抗体杂质去除策略

Strategies for removing the impurities from bispecific antibodies

  • 摘要: 双特异性抗体(双抗)凭借其双靶向能力在肿瘤治疗中展现出显著疗效,但其结构的复杂性导致其在生产过程中产生多种工艺相关杂质(如宿主细胞蛋白、宿主细胞核酸和Protein A)和产品相关杂质(如半抗体、3/4抗体、同源二聚体、缺一条Fab臂的双抗杂质和聚集体)等。本文系统总结了双抗下游纯化策略:通过亲和色谱、深层过滤、羟基磷灰石色谱、疏水相互作用色谱、离子交换色谱及多模式色谱等纯化技术高效去除各种杂质,旨在为双抗的纯化提供理论支持。

     

    Abstract: Bispecific antibodies have shown significant efficacy in tumor therapy due to their dual targeting ability, but the complexity of their structure leads to the production of various process-related impurities such as host cell proteins, host cell DNA, and Protein A, and product-related impurities such as semi antibodies, 3/4 antibodies, homodimers, bispecific antibodies lacking one Fab arm, and aggregates during the manufacturing process. This paper systematically summarizes downstream purification strategies for dual antibodies, including affinity chromatography, deep filtration, hydroxyapatite chromatography, hydrophobic interaction chromatography, ion exchange chromatography, and multimodal chromatography, to efficiently remove various impurities and provide theoretical support for the purification of dual antibodies.

     

/

返回文章
返回