Residual hydrogen peroxide (HP) from the vapor-phase HP (VPHP) isolator decontamination process can diffuse into drug product, potentially resulting in significant protein oxidation and thus impacting product quality. The effect of absorbed VPHP on a lyophilized product Protein Z, was studied by spiking experiments with different amounts of hydrogen peroxide and the stability of the lyophilized product was studied for up to six months.

Analytics

Aseptic/Sterile Processing

Fill-Finish

Manufacturing

Manufacturing, Biologic Drugs

Manufacturing, Drug Products

Manufacturing, Lyophilization

Manufacturing, Parenterals and Injectables

Pharmaceutical Technology-05-15-2014

The effect of absorbed vapor-phase hydrogen peroxide on a lyophilized product Protein Z, was studied by spiking experiments with different amounts of hydrogen peroxide.

Determining Protein Oxidation Induced During Fill-Finish Operations