Be Aggressive! Amorphous Excipients Enabling Single-Step Freeze-Drying of Monoclonal Antibody Formulations

• Egile Nagusiak: Christina Haeuser (Egilea), Pierre Goldbach (Egilea), Joerg Huwyler (Egilea), Wolfgang Friess (Egilea), Andrea Allmendinger (Egilea)
• Formatua: Liburua
• Argitaratua: MDPI AG, 2019-11-01T00:00:00Z.
• Gaiak: article
• Sarrera elektronikoa: Connect to this object online.

Short freeze-drying cycles for biopharmaceuticals are desirable. Formulations containing an amorphous disaccharide, such as sucrose, are prone to collapse upon aggressive primary drying at higher shelf temperature. We used 2-hydroxypropyl-betacyclodextrin (HPBCD) in combination with sucrose and poly...