Novel Mechanism of Glass Delamination in Type 1A Borosilicate Vials Containing Frozen Protein Formulations.

Unlabelled: Storing protein formulations in the frozen state typically improves stability during long-term storage as a drug substance or as a drug product. The frozen state minimizes chemical degradation and physical instability. However, the frozen state is not an optimal storage condition for the glass vial itself.

Using statistical analysis for setting process validation acceptance criteria for biotech products.

This paper discusses the challenges of setting process validation acceptance criteria for biotech products for cases where using statistical tools is appropriate. Data are analyzed under three different scenarios that are frequently encountered in biotech applications. Scenario A represents the case when a small data set around center point conditions is available for setting acceptance criteria.