Drying of biologics typically offer a longer-term storage stability compared to the corresponding liquid dosage forms. Lyophilization has been the traditional drying technique for biologics, however, it is often criticized for its low energy efficiency and high cost. Thus, new drying techniques are needed for the next generation of biologics in dry dosage forms. In this study, three drying technologies, spray drying (SD), spin freeze drying (Spin FZ) and spray freeze drying (Spray FD) were evaluated in comparison to lyophilization (Lyo). SD and Spray FD involve the atomization of protein solution into fine droplets that are either dried in hot air stream in SD or get frozen then lyophilized in Spray FD. Spin FZ is a less aggressive method with comparable freezing and drying temperatures to Lyo. A mAb in histidine formulation at pH6 was used as a model molecule and formulation for the current study. The product morphology and water content, in addition to the physical stability of protein, including monomer loss, visual appearance and subvisible particle count (SVP) after reconstitution, were evaluated for the dried products at 40 °C up to 6 months. The dried solids were also characterized by advanced solid state characterization technologies such as ssHDX and ssNMR.
Learning Objectives:
Know the pros and cons of several advanced drying technologies to be used for biologics.
Know how some of the advanced solid state characterization techniques have been used to understand protein stability from the dried solids.
Know the key factors determining the success development of biotherapeutic drug products with new drying technologies other than lyophilization.
