Structure-Guided In-Use Stability Assessment of Monoclonal Antibody Tislelizumab.

ABSTRACT: Background/Objectives: Monoclonal antibody (mAb) stability is critical not only during manufacturing but also at the point of clinical administration. For therapies like tislelizumab (Tevimbra), a programmed death-1 (PD-1) targeting IgG mAb, delays in dosing often result in prepared infusions being discarded, contributing to substantial drug waste despite being engineered for improved stability. Methods: To evaluate the physicochemical in-use stability of tislelizumab in a ready-to-administer format, we mapped degradation pathways, including post-translational modifications (PTMs); peptide alterations; pH and solution characteristics-under 12-month storage (ultra-long), under 1-month storage (0, 7, 14, 21, 28 and 31 days), and under exposure-related forced degradation conditi

SUBMITTER: Rudd DA 

PROVIDER: S-EPMC12567146 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature