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

• Main Authors: Christina Haeuser (Author), Pierre Goldbach (Author), Joerg Huwyler (Author), Wolfgang Friess (Author), Andrea Allmendinger (Author)
• Formato: Livro
• Publicado em: MDPI AG, 2019-11-01T00:00:00Z.
• Assuntos: article
• Acesso em linha: 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...