News|Articles|May 15, 2014
- Pharmaceutical Technology-05-15-2014
- Volume 2014 eBook
- Issue 2
Determining Protein Oxidation Induced During Fill-Finish Operations
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.
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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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Articles in this issue
over 11 years ago
Potential Benefits Drive Interest in Continuous Manufacturingover 11 years ago
Continuous Bioprocessing Challengesover 11 years ago
Optimizing the Sterilization of Liquids in Sealed Containersover 11 years ago
Using Modular Systems in Biopharmaceutical Manufacturingover 11 years ago
Single-Use Technology in Parenteral Fill/FinishNewsletter
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