Safe Freeze-Thaw of Protein Drug Products: A QbD Approach.

The article presents a Quality by Design (QbD) approach to define a safe freeze-thaw space where a protein's quality is not affected by the freezing or the thawing method used. It evaluates the sustainability of the laboratory-scale Celsius S3 system as screening tool for determining a safe-thaw space. It notes that protein quality during freezing or thawing is governed by several chemical and physical phenomena linked to the way that the protein is frozen or thawed.