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Qualification of NISTmAb charge heterogeneity control assays

Published

Author(s)

Abigail Turner, John E. Schiel

Abstract

The NISTmAb is a monoclonal antibody Reference Material from the National Institute of Standards and Technology; it is a class-representative IgG1κ intended serve as a pre-competitive platform for harmonization and technology development in the biopharmaceutical industry. The publication series of which this paper is a part describes NIST's overall control strategy to ensure NISTmAb quality and availability over its lifecycle. In this paper, the development and qualification of methods for monitoring NISTmAb charge heterogeneity are described. Capillary zone electrophoresis (CZE) and capillary isoelectric focusing (CIEF) assays were optimized and evaluated as candidate assays for NISTmAb quality control. CIEF was found to be suitable as a structural characterization assay yielding information on the apparent pI of the NISTmAb. CZE was found to be better suited for routine monitoring of NISTmAb charge heterogeneity and was qualified for this purpose. This paper is intended to provide relevant details of NIST's charge heterogeneity control strategy to facilitate implementation of the NISTmAb as a test molecule in the end user's laboratory.
Citation
Analytical and Bioanalytical Chemistry

Keywords

NISTmAb, Biopharmaceutical, Capillary Electrophoresis

Citation

Turner, A. and Schiel, J. (2018), Qualification of NISTmAb charge heterogeneity control assays, Analytical and Bioanalytical Chemistry, [online], https://doi.org/10.1007/s00216-017-0816-6 (Accessed May 24, 2024)

Issues

If you have any questions about this publication or are having problems accessing it, please contact reflib@nist.gov.

Created March 18, 2018, Updated October 13, 2022