Interlaboratory Studies using the NISTmAb to Advance Biopharmaceutical Structural Analytics

Published

May 5, 2022

Author(s)

Katharina Yandrofski, Trina Mouchahoir, M. Lorna De Leoz, David L. Duewer, Jeffrey W. Hudgens, Kyle Anderson, Luke Arbogast, Frank Delaglio, Robert Brinson, John Marino, Karen W. Phinney, Michael J. Tarlov, John E. Schiel

Abstract

Biopharmaceuticals such as monoclonal antibodies are required to be rigorously characterized using a wide range of analytical methods. Various material properties must be characterized and well controlled to assure that clinically relevant features and critical quality attributes are maintained. A thorough understanding of the performance metrics of an analytical method, particularly emerging methods designed to address measurement gaps, using an industrially relevant test system is required to assure that applied methods are implemented in a manner conducive to their intended use in assuring drug safety, stability, and functional activity. To this end, a series of interlaboratory studies have been conducted using NISTmAb, a biopharmaceutical-representative and publicly available test material, to report on state-of-the-art method performance, harmonize best practices, and inform on potential gaps in the analytical measurement infrastructure. Reported here is a summary of the study designs, results and future perspectives revealed from these interlaboratory studies which focused on primary structure, post-translational modifications, and higher order structure measurements currently employed during biopharmaceutical development.

Citation

Frontiers in Molecular Biosciences

Pub Type

Journals

Download Paper

https://doi.org/10.3389/fmolb.2022.876780

Local Download

Keywords

Monoclonal Antibody, Biopharmaceutical, NISTmAb, Therapeutic Protein, Interlaboratory Study

Citation

Yandrofski, K. , Mouchahoir, T. , De Leoz, M. , Duewer, D. , Hudgens, J. , Anderson, K. , Arbogast, L. , Delaglio, F. , Brinson, R. , Marino, J. , Phinney, K. , Tarlov, M. and Schiel, J. (2022), Interlaboratory Studies using the NISTmAb to Advance Biopharmaceutical Structural Analytics, Frontiers in Molecular Biosciences, [online], https://doi.org/10.3389/fmolb.2022.876780, https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=934084 (Accessed October 9, 2025)