Electrostatic and hydrophobic contributions to monoclonal antibody adsorption on prefilled syringes: a screening...

Protein adsorption to primary packaging surfaces, especially prefilled syringes (PFS), is a critical issue in biopharmaceutical development because it can lower drug concentration and promote aggregation and particle formation. In this study, we examined the adsorption of a monoclonal antibody (mAb) on relevant barrel materials, including borosilicate glass (siliconized and unsiliconized) and cyclic olefin polymer (COP), using dynamic streaming potential analysis on as-received PFS. This method enables real-time measurement of adsorption kinetics directly in the actual rounded syringe geometry. We assessed the effects of syringe material, siliconization, and polysorbate 80 (PS80) concentration on mAb adsorption. Adsorption was highest on unsiliconized glass, intermediate on COP, and lowest on siliconized glass, while increasing PS80 concentration reduced adsorption across all syringe types. To explain adsorption trends across a broader range of materials, we related mAb adsorption to zeta potential and contact angle. Adsorption increased with more negative zeta potential and higher contact angle of the primary packaging material, indicating that protein binding is independently influenced by both nonpolar interactions and charge-based interactions. Overall, the study highlights the value of surface analysis of as received primary packaging materials for characterizing mAb adsorption by dynamic streaming potential analysis as a rapid in-syringe screening tool for formulation and packaging development under real-life conditions.