Scale-up/tech transfer issues of the lyophilization cycle for biopharmaceuticals and recently emerging technologies and approaches

Abstract

The global market for biopharmaceuticals is currently growing, and lyophilization is becoming increasingly important. Lyophilization is a time- and cost-consuming process for which the programs and recipes must be optimized to ensure product quality with minimum process time. However, a sufficient number of experiments for optimization of production-scale lyophilizers have not been performed due to limitations in actual pharmaceutical development, and a breakthrough approach is required to establish optimal lyophilization conditions with the limited experimental data available. Although there are a great number of published works associated with lyophilization of pharmaceutical products, the scale-up/tech transfer of the lyophilization process for biopharmaceuticals is still difficult. This review aims to discuss the difficulty of process development of lyophilization from an industry perspective and to introduce promising novel technologies and approaches and new findings related to successful lyophilization of biopharmaceuticals.

Keywords:

• lyophilization
• freeze-drying
• biopharmaceutical
• scale-up
• tech transfer