Developing Lyophilized Formulations for Protein Biopharmaceuticals Containing Salt that Produce Placebos of Corresponding Appearance.

ABSTRACT

Obtaining an elegant finished pharmaceutical product remains a problem when salt concentration is high, protein concentration is low, and particularly when both conditions are combined. We propose a simple approach to develop a robust lyophilized formulation in the presence of salt and at low protein concentration. We combine this with a commercially viable lyophilization cycle that can serve as a starting point for many protein-based pharmaceutical products. In this manner the formulator scientist, even with little experience, can develop a robust and visually acceptable lyophilized product. In addition, this platform allows the production of placebo vials with no visual differences compared to the active product.