In:
Journal of Separation Science, Wiley, Vol. 35, No. 22 ( 2012-11), p. 3124-3129
Abstract:
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.
Type of Medium:
Online Resource
ISSN:
1615-9306
,
1615-9314
DOI:
10.1002/jssc.201200633
Language:
English
Publisher:
Wiley
Publication Date:
2012
detail.hit.zdb_id:
2047990-6
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