Mitigation Strategies against Antibody Aggregation Induced by Oleic Acid in Liquid Formulations DOI Creative Commons
Dominik Zürcher, Klaus Wuchner, Paolo Arosio

и другие.

Molecular Pharmaceutics, Год журнала: 2024, Номер unknown

Опубликована: Окт. 23, 2024

Polysorbates 20 and 80 (PS20 PS80) are commonly used in the formulations of biologics to protect against interfacial stresses. However, these surfactants can degrade over time, releasing free fatty acids, which assemble into solid particles or liquid droplets. Here, we apply a droplet microfluidic platform analyze interactions between antibodies oleic acid, primary acid resulting from hydrolysis PS80. We show that adsorb within seconds polar acid-water interface, forming viscoelastic protein layer leads particle formation upon mechanical rupture. By testing two different monoclonal pharmaceutical origin, propensity form rigid is protein-specific. further demonstrate intact PS80 effective preventing antibody adsorption at interface only low concentrations pH, where fully protonated. Importantly, introduction amino l-arginine prevents even high (180 mg mL

Язык: Английский

Mitigation Strategies against Antibody Aggregation Induced by Oleic Acid in Liquid Formulations DOI Creative Commons
Dominik Zürcher, Klaus Wuchner, Paolo Arosio

и другие.

Molecular Pharmaceutics, Год журнала: 2024, Номер unknown

Опубликована: Окт. 23, 2024

Polysorbates 20 and 80 (PS20 PS80) are commonly used in the formulations of biologics to protect against interfacial stresses. However, these surfactants can degrade over time, releasing free fatty acids, which assemble into solid particles or liquid droplets. Here, we apply a droplet microfluidic platform analyze interactions between antibodies oleic acid, primary acid resulting from hydrolysis PS80. We show that adsorb within seconds polar acid-water interface, forming viscoelastic protein layer leads particle formation upon mechanical rupture. By testing two different monoclonal pharmaceutical origin, propensity form rigid is protein-specific. further demonstrate intact PS80 effective preventing antibody adsorption at interface only low concentrations pH, where fully protonated. Importantly, introduction amino l-arginine prevents even high (180 mg mL

Язык: Английский

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