Using Freeze-Drying to Stabilize Formulations of Monoclonal Antibodies
摘要
Freeze-drying, also known as lyophilization, is a significant process for stabilizing monoclonal antibody (mAb) products, resulting in increased shelf life, greater stability, and less complicated storage and transit. Lyophilization, which removes moisture from mAb solutions via sublimation, inhibits common degradation mechanisms such as hydrolysis and aggregation, rendering it a crucial strategy for preserving the biological properties found in these sensitive biological products. Improvements in formulation research and process control concepts have considerably enhanced the freeze-drying process, resulting in greater effectiveness and product uniformity. Nevertheless, lyophilization of mAbs raises various obstacles, like protein aggregation, reconstitution challenges, lengthy processing lengths, and structural alterations after drying. To solve these issues, sophisticated formulation design, precise process parameter control, and innovations like controlled nucleation and alternate drying methods are required. As mAb therapies gain popularity and high-concentration formulations become more widespread, ongoing research and technology improvements will be vital to improving its lyophilization over next-generation biologics. This chapter discusses how the ongoing improvement of lyophilization technology remains crucial for meeting the growing demand for mAb-based treatments and biologics.