The effect of glass container surface silanol density on monoclonal antibody formulation stability after application of mechanical shock

Abstract

This study investigates the effect of silanol density on the surface of glass containers on the stability of monoclonal antibody (mAb) formulations subjected to mechanical stress. By calcining Type I glass containers at different temperatures, we altered the concentration of silanols on the glass surface and examined its impact on the stability of protein formulations under mechanical stress. Contact angle measurements and Fourier Transform Infrared (FTIR) spectroscopy indicated that silanol formation influences the hydrophilicity of the surface. Additionally, mAb solutions filled in Type I glass containers with varying silanol densities were repeatedly dropped from a height of 0.5 m to simulate mechanical stress during transport. The results demonstrated that increasing surface silanol density reduces protein monomer loss and the formation of protein aggregates and subvisible particles. Furthermore, protein aggregates and subvisible particles formed by dropping did not activate the complement in human serum in vitro. Adjusting the silanol density on the glass container surface offers an economical and environmentally friendly approach to improving the stability of mAb formulations during transportation.

Keywords: Glass surface; Monoclonal antibody; Primary packaging; Protein stability; Silanol.