Robustness of iCIEF methodology for the analysis of monoclonal antibodies: An interlaboratory study

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 differ...

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Bibliographic Details
Published in:Journal of separation science 2012-11, Vol.35 (22), p.3124-3129
Main Authors: Salas-Solano, Oscar, Kennel, Babu, Park, SungAe Suhr, Roby, Kelly, Sosic, Zoran, Boumajny, Boris, Free, Sarah, Reed-Bogan, Angelia, Michels, David, McElroy, Will, Bonasia, Pauline, Hong, Mingfang, He, Xiaoping, Ruesch, Margaret, Moffatt, Frank, Kiessig, Steffen, Nunnally, Brian
Format: Article
Language:English
Subjects:
Analytical chemistry
Antibodies, Monoclonal - analysis
Biopharmaceutical analysis
Capillarity
Capillary electrophoresis
Charging
CIEF
Consistency
Electrophoresis, Capillary - methods
Electrophoresis, Capillary - standards
Heterogeneity
Humans
Imaged capillary isoelectric-focusing
Interlaboratory
Isoelectric focusing
Isoelectric Focusing - methods
Isoelectric Focusing - standards
Laboratories - standards
Monoclonal antibodies
Pharmaceuticals
Protein Isoforms - analysis
Robustness
Samples
Switzerland
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Summary: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.
ISSN:1615-9306
1615-9314
DOI:10.1002/jssc.201200633