European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.VFreeze DryingHistidineBuffersAntibodiesMonoclonal
A novel histidine-acetate buffer for freeze-dried monoclonal antibody formulations.
Jia-Yi Lv, Han Gao, Huan-Fang Xie, Meng-Jia Jin, Bin Di, Jin Xu, Wei-Jie Fang
Published: 202610.1016/j.ejpb.2025.114940
Abstract
Histidine (His)-hydrochloride (HCl) is widely used in freeze-dried monoclonal antibody (mAb) formulations, but alternative buffers are required when chloride ions are undesirable. This study evaluates His-acetate (Ac) as a substitute and its impact o…
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