Skip to main content
U.S. flag

An official website of the United States government

Official websites use .gov
A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS
A lock ( ) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

Development of Orthogonal NISTmAb Size Heterogeneity Control Methods



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


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.
Analytical and Bioanalytical Chemistry


Reference Material, NISTmAb, monoclonal antibody, biotherapeutic, biopharmaceutical


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], (Accessed March 2, 2024)
Created February 9, 2018, Updated October 12, 2021