Higher concentration of trehalose dihydrate stabilizes recombinant IgG1 under forced stress conditions

Journal of Pharmaceutical Sciences, Journal Year: 2025, Volume and Issue: unknown

Published: Jan. 1, 2025

Stability of complex biotherapeutics like monoclonal antibodies is paramount for their safe and efficacious use. Excipients are inactive ingredients that added to the purified product so as offer it a stable environment. Trehalose dihydrate non-reducing sugar commonly used stabilizing agent in biotherapeutic formulations under liquid frozen states. The effect trehalose against aggregation protein well known. present study aims insights into stability effects higher concentration (230 mM) on trastuzumab different forced stress conditions including thermal, light with without hydrogen peroxide (H

Language: Английский

Impact of Protein Adsorption During Biopharmaceutical Manufacture & Storage

European Journal of Pharmaceutical Sciences, Journal Year: 2025, Volume and Issue: unknown, P. 107071 - 107071

Published: March 1, 2025

Language: Английский

Challenges with effective removal of surfactants from monoclonal antibody formulations

International Journal of Pharmaceutics, Journal Year: 2024, Volume and Issue: unknown, P. 125146 - 125146

Published: Dec. 1, 2024

Language: Английский