Native peptide mapping - A simple method to routinely monitor higher order structure changes and relation to functional activity.

ABSTRACT: In the biopharmaceutical environment, controlling the Critical Quality Attributes (CQA) of a product is essential to prevent changes that affect its safety or efficacy. Physico-chemical techniques and bioassays are used to screen and monitor these CQAs. The higher order structure (HOS) is a CQA that is typically studied using techniques that are not commonly considered amenable to quality control laboratories. Here, we propose a peptide mapping-based method, named native peptide mapping, which could be considered as straightforward for HOS analysis and applicable for IgG4 and IgG1 antibodies. The method was demonstrated to be fit-for-purpose as a stability-indicating assay by showing differences at the peptide level between stressed and unstressed material. The unfolding pathway induced by

SUBMITTER: Degueldre M 

PROVIDER: S-EPMC6816347 | biostudies-literature | 2019 Nov-Dec

REPOSITORIES: biostudies-literature