Intercompany Study to Evaluate the Robustness of Capillary Isoelectric Focusing Technology for the Analysis of Monoclonal Antibodies
Intercompany Study to Evaluate the Robustness of Capillary Isoelectric Focusing Technology for the Analysis of Monoclonal Antibodies
复制标题
评估用于单克隆抗体分析的毛细管等电聚焦技术稳健性的公司间研究
DOI：
10.1007/s10337-011-2017-3
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发表时间：
2011
期刊：
影响因子：
1.7
通讯作者：
B. Nunnally
中科院分区：
文献类型：
--
作者：
O. Salas‐Solano;K. Babu;Sungae S Park;Xinfeng Zhang;Li Zhang;Z. Sosic;Boris Boumajny;M. Zeng;K. Cheng;A. Reed;Stacey Cummins;D. Michels;M. Parker;Paulina Bonasia;M. Hong;S. Cook;M. Ruesch;D. Lamb;D. Bolyan;S. Kiessig;Darren Allender;B. Nunnally
实验室间比较对于将新兴技术引入生物制药行业实践和监管接受至关重要。因此，成立了一个国际团队，包括来自美国和瑞士10家独立生物制药公司的12个实验室，以评估毛细管等电聚焦（CIEF）的精密度和耐用性，以评估单克隆抗体的电荷异质性。不同实验室使用相同的CIEF方法测定了代表性单克隆抗体（rMAb）样品的表观pI和电荷亚型的相对分布。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。各电荷变体峰生成的表观pI数据显示实验室间精密度非常好，RSD值百分比≤ 0.5%。同样，不同实验室、不同分析员使用不同批次两性电解质和多台仪器时，rMAb电荷变体峰面积百分比值的RSD百分比≤4.4%。总之，这些结果验证了CIEF在生物制药行业中的适当使用，以支持监管申报。
Interlaboratory comparisons are essential to bringing emerging technologies into biopharmaceutical industry practice and regulatory acceptance. As a result, an international team including 12 laboratories from 10 independent biopharmaceutical companies in the United States and Switzerland was formed to evaluate the precision and robustness of capillary isoelectric focusing (CIEF) to assess the charge heterogeneity of monoclonal antibodies. The different laboratories determined the apparent pI and the relative distribution of the charge isoforms of a representative monoclonal antibody (rMAb) sample using the same CIEF method. Statistical evaluation of the data was performed to determine within and between-laboratory consistencies and outlying information. The apparent pI data generated for each charge variant peak showed very good precision between laboratories with percentage of RSD values of ≤0.5%. Similarly, the percentage of RSD for the rMAb charge variants percent peak area values are ≤4.4% across different laboratories with different analysts using different lots of ampholytes and multiple instruments. Taken together, these results validate the appropriate use of CIEF in the biopharmaceutical industry in support of regulatory submissions.