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

Published

March 31, 2023

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

NIST Pub Series

Special Publication (NIST SP)

Pub Type

NIST Pubs

Download Paper

https://doi.org/10.6028/NIST.SP.260-237

Local Download

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 November 21, 2024)