Development of Orthogonal NISTmAb Size Heterogeneity Control Methods

Published

February 10, 2018

Author(s)

Abigail Turner, Katharina S. Yandrofski, Srivalli Telikepalli, N. Alan Heckert, James J. Filliben, Dean C. Ripple, John E. Schiel

Abstract

The NISTmAb is an innovative monoclonal antibody reference material from the National Institute of Standards and Technology; it is a class-representative IgG1κ intended to 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 of a control strategy for monitoring NISTmAb size heterogeneity over its lifecycle is described. Optimization and qualification of size heterogeneity measurement spanning a broad size range are described, including capillary electrophoresis-sodium dodecyl sulfate (CE-SDS), size exclusion chromatography (SEC), dynamic light scattering (DLS), and flow imaging analysis. This paper is intended to provide relevant details of NIST's size heterogeneity control strategy to facilitate implementation of the NISTmAb as a test molecule in the end user's laboratory.

Citation

Analytical and Bioanalytical Chemistry

Volume

410

Issue

8

Pub Type

Journals

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DOI Link

Keywords

Reference Material, NISTmAb, monoclonal antibody, biotherapeutic, biopharmaceutical

Citation

Turner, A. , Yandrofski, K. , Telikepalli, S. , Heckert, N. , Filliben, J. , Ripple, D. and Schiel, J. (2018), Development of Orthogonal NISTmAb Size Heterogeneity Control Methods, Analytical and Bioanalytical Chemistry, [online], https://doi.org/10.1007/s00216-017-0819-3 (Accessed October 28, 2025)