The Influence of Arginine and Counter-Ions: Antibody Stability during Freeze-Drying

Amino acids, for example L-arginine, are used in lyophilisation as crystalline bulking, buffering, viscosity reducing or stabilising excipients. In this study, arginine was formulated with different counter ions (hydrochloride, citrate, lactobionate, phosphate, and succinate). A monoclonal antibody investigated sugar-free formulations mixtures sucrose regarding cake appearance protein aggregation fragmentation. Arginine hydrochloride collapsed during due to its low Tg’ partially crystallised storage, but provided the best stability at concentration, followed by succinate. citrate/phosphate/lactobionate resulted amorphous elegant cakes, inferior stability. Addition of improved phosphate similar reference. Mixtures hydrochloride/lactobionate/succinate better than alone. While 50 mg/mL appearance, only lactobionate sufficient next sucrose. Overall, lyophilisates stabilised comparably depending on concentration. The found