Robustness of iCIEF methodology for the analysis of monoclonal antibodies: An interlaboratory study
Robustness of iCIEF methodology for the analysis of monoclonal antibodies: An interlaboratory study
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DOI：
10.1002/jssc.201200633
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发表时间：
2012-11-01
影响因子：
3.1
通讯作者：
Nunnally, Brian
中科院分区：
文献类型：
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作者：
Salas-Solano, Oscar;Kennel, Babu;Nunnally, Brian
成立了一个国际团队，包括来自美国和瑞士11家独立生物制药公司的12个实验室，以评估成像毛细管等电聚焦用于单克隆抗体电荷异质性分析的精密度和稳健性。不同的实验室使用相同的毛细管等电聚焦试验测定了代表性单克隆抗体样品的表观pI和带电亚型的相对分布。对数据进行统计学评价，以确定实验室内和实验室间的异常和异常信息。各带电变体峰生成的表观pI数据显示实验室间精密度非常好，RSD值小于0.8%。同样，使用不同分析员、不同批次两性电解质和多台仪器的不同实验室中，治疗性单克隆抗体带电变体峰面积百分比值的RSD小于11%。这些结果验证了成像毛细管等电聚焦在生物制药行业中的适当使用，以支持治疗性抗体的工艺开发和监管提交。
An international team including 12 laboratories from 11 independent biopharmaceutical companies in the United States and Switzerland was formed to evaluate the precision and robustness of imaged capillary isoelectric focusing for the charge heterogeneity analysis of monoclonal antibodies. The different laboratories determined the apparent pI and the relative distribution of the charged isoforms for a representative monoclonal antibody sample using the same capillary isoelectric focusing assay. Statistical evaluation of the data was performed to determine within and between laboratory consistencies and outlying information. The apparent pI data generated for each charged variant peak showed very good precision between laboratories with RSD values of less than 0.8%. Similarly, the RSD for the therapeutic monoclonal antibody charged variants percent peak area values are less than 11% across different laboratories using different analyst, different lots of ampholytes and multiple instruments. These results validate the appropriate use of imaged capillary isoelectric focusing in the biopharmaceutical industry in support of process development and regulatory submissions of therapeutic antibodies.