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

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 concentra-tion. 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 expe-rience, 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.(c) 2022 Published by Elsevier Inc. on behalf of American Pharmacists Association.

Automated summary

This article presents a simple approach to develop a robust lyophilized formulation in the presence of salt and at low protein concentration, combined with a commercially viable lyophilization cycle. It can be used as a starting point for the development of protein-based pharmaceutical products and allows the production of placebo vials with no visual differences compared to the active product.