Interlaboratory Studies Using the NISTmAb to Advance Biopharmaceutical Structural Analytics.

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 analytical method performance metrics, particularly emerging methods designed to address measurement gaps, is required to assure methods are appropriate for 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 monoclonal antibody test material, to report on state-of-the-art method performance, harmonize b

SUBMITTER: Yandrofski K 

PROVIDER: S-EPMC9117750 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature