Identification of critical chemical modifications and paratope mapping by size exclusion chromatography of stressed antibody-target complexes.

ABSTRACT: Therapeutic proteins including antibodies and Fc-fusion proteins undergo a large number of chemical modifications during cell culture, purification, storage and in human circulation. They are also exposed to harsh conditions during stress studies, including elevated temperature, extremes of pH, forced oxidation, physiological pH, UV light to assess the possible degradation pathways and suitability of methods for detecting them. Some of these modifications are located on residues in binding regions, leading to loss of binding and potency and classified as critical quality attributes. Currently, criticality of modifications is assessed by a laborious process of collecting antibody fractions from the soft chromatography techniques ion exchange and hydrophobic interaction chromatography and ch

SUBMITTER: Bondarenko P 

PROVIDER: S-EPMC7899697 | biostudies-literature | 2021 Jan-Dec

REPOSITORIES: biostudies-literature