Stabilization of glycoprotein liquid formulation using arginine: a study with lactoferrin as a model protein.

The formulation of new biotherapeutics without human serum albumin (HSA) could decrease the potential risk of blood-transmitted diseases and those caused by infectious viruses and other pathogens. In the present study, arginine was examined as a potential alternative to HAS, and bovine lactoferrin (bLf) was used as a representative model glycoprotein since bLf has potential immunomodulatory and antiviral activity. The optimal formulation for the mixture was determined to be 10 mM arginine, 15% (w/v) trehalose, and 0.02% (v/v) Tween 80, using a statistical analysis program, Minitab. Analyses were performed using reverse-phase high-performance liquid chromatography (HPLC) and SDS-PAGE. The blf HSA-free formulations lost only 12-20% of blf compared with 46% for control (without additives) after 28 d of storage. Based on long-term stability studies, the HSA-free formulation developed in this study had a stronger effect on the stability of bLf (1.4-fold) than HSA formulation under various storage conditions over 6 months.