Assessing the Comparability of Degradation Profiles Between Biosimilar and Originator Anti-VEGF Monoclonal Antibodies Under Thermal Stress.

ABSTRACT: Background/Objectives: Forced degradation studies are critical for identifying potential degradation pathways of monoclonal antibodies (mAbs), particularly under thermal stress. Due to their structural complexity and sensitivity to elevated temperatures, mAbs are prone to fragmentation, aggregation, and post-translational modifications. This study aimed to evaluate and compare the degradation profiles of biosimilar anti-VEGF mAb and its originator counterparts sourced from both the United States (U.S.) and the European Union (EU) under thermal stress conditions. To our knowledge, this represents one of the few studies conducting a direct head-to-head comparability assessment across biosimilar and two geographically sourced originators, integrating orthogonal analytical approaches. <

SUBMITTER: Pamukcu C 

PROVIDER: S-EPMC12472202 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature