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The NISTmAb Reference Material 8671 Value Assignment, Homogeneity, and Stability

Published

Author(s)

John E. Schiel, Abigail Turner, Catherine A. Mouchahoir, Katharina S. Yandrofski, Srivalli Telikepalli, Jason King, Paul C. DeRose, Dean C. Ripple, Karen W. Phinney

Abstract

The NISTmAb Reference Material (RM) 8671 is intended to be the common industry standard monoclonal antibody for pre-competitive research in harmonizing current state-of-the-art technology and designing next generation characterization technologies for identity, quality, and stability testing. It must therefore embody the quality and characteristics of a typical biopharmaceutical product and be available for the long term in a stable format with consistent product quality attributes. A stratified sampling and analysis plan using a series of qualified analytical and biophysical methods is described that assures RM 8671 meets these criteria. Results for the first three lots of RM 8671 highlight the consistency of material attributes with respect to size, charge, and identity. RM 8671 was verified to be homogeneous both within and between vialing lots, demonstrating the robustness of the lifecycle management plan. It was analyzed in concert with the in-house primary sample 8670 (PS 8670) to provide a historical link to this seminal material. RM 8671 was verified to be fit for its intended purpose as a technology innovation tool, external system suitability control, and cross-industry harmonization platform.
Citation
Analytical and Bioanalytical Chemistry
Volume
410
Issue
8

Keywords

Reference Material, NISTmAb, monoclonal antibody, biotherapeutic, biopharmaceutical

Citation

Schiel, J. , Turner, A. , Mouchahoir, C. , Yandrofski, K. , Telikepalli, S. , King, J. , DeRose, P. , Ripple, D. and Phinney, K. (2018), The NISTmAb Reference Material 8671 Value Assignment, Homogeneity, and Stability, Analytical and Bioanalytical Chemistry, [online], https://doi.org/10.1007/s00216-017-0800-1 (Accessed August 3, 2021)
Created March 1, 2018, Updated April 19, 2020