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

2012; Wiley; Volume: 35; Issue: 22 Linguagem: Inglês

10.1002/jssc.201200633

1615-9314

Oscar Salas‐Solano, Babu Kennel, SungAe Suhr Park, Kelly Roby, Zoran Sosic, Boris Boumajny, Sarah Free, Angelia Reed‐Bogan, David A. Michels, Will McElroy, Pauline Bonasia, Mingfang Hong, Xiaoping He, Margaret Ruesch, Frank Moffatt, Steffen Kiessig, Brian K. Nunnally,

Microfluidic and Bio-sensing Technologies

An international team including 12 laboratories from 11 independent biopharmaceutical companies in the U nited S tates and S witzerland 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 p I 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 p I 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.