European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.VAntibodiesMonoclonalSyringesTungstenDrug Stability
Tungsten residues in prefilled syringes promote monoclonal antibody aggregation and charge heterogeneity.
Chao-Yang Du, Min Zou, Zi-Ting Xu, Wei Zhao, Miao Chen, Wei-Jie Fang
Published: 202510.1016/j.ejpb.2025.114900
Abstract
Monoclonal antibodies (mAbs) are pivotal therapeutics; however, their stability during production and storage remains a critical challenge, particularly in prefilled syringes (PFS), where tungsten residues from manufacturing can compromise quality. T…
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