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.

Humanized Monoclonal Antibody IgG1k, NISTmAb RM 8671 Summary of 5 Year Stability Verification (5YSV)

Published

Author(s)

Katharina Yandrofski, John E. Schiel, Trina Mouchahoir, Srivalli Telikepalli, N. Alan Heckert, Dean C. Ripple, Paul C. DeRose, Karen W. Phinney, John Marino

Abstract

NISTmAb RM 8671 is an IgG1κ monoclonal antibody that has been extensively characterized and released as the first of its kind biopharmaceutical reference material in 2016. This material was intended primarily for use in evaluating the performance of methods for determining physicochemical and biophysical attributes of monoclonal antibodies. It also provides a representative test molecule for development of novel technologies for therapeutic protein characterization. The lifecycle management of NISTmAb includes a long-term stability verification to evaluate the homogeneity and stability for the first 3 lots (14HB-D-001, 14HB-D-002, and 14HB-D-003) of this material. Initial certification to assign property values and confirm identification used a wide variety of analytical methods including UV-Vis spectrophotometry, size exclusion chromatography, capillary electrophoresis, dynamic light scattering, flow imaging, and peptide mapping. Reported here is a summary of these analytical methods and results for the 5-year stability verification (5YSV) for RM 8671 demonstrating the material is homogeneous and stable.
Citation
Special Publication (NIST SP) - 260-237
Report Number
260-237

Keywords

Reference Material, NISTmAb, Monoclonal Antibody, Biotherapeutic, Biopharmaceutical, System Suitability

Citation

Yandrofski, K. , Schiel, J. , Mouchahoir, T. , Telikepalli, S. , Heckert, N. , Ripple, D. , DeRose, P. , Phinney, K. and Marino, J. (2023), Humanized Monoclonal Antibody IgG1k, NISTmAb RM 8671 Summary of 5 Year Stability Verification (5YSV), Special Publication (NIST SP), National Institute of Standards and Technology, Gaithersburg, MD, [online], https://doi.org/10.6028/NIST.SP.260-237, https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=936497 (Accessed April 20, 2024)
Created March 31, 2023