Determining Protein Oxidation Induced During Fill-Finish Operations

Author(s)Konstantin Konstantinov, Mark Yang, Sangeeta Benjwal

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.

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.

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