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Pharmaceutical Technology

Pharmaceutical Technology-05-15-2014
Volume2014 eBook
Issue 2

Determining Protein Oxidation Induced During Fill-Finish Operations

Author(s):

Konstantin Konstantinov,Mark Yang

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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Articles in this issue
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Potential Benefits Drive Interest in Continuous Manufacturing
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Continuous Bioprocessing Challenges
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Determining Cross-Contamination Risks in Multiproduct Biopharmaceutical Facilities
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Achieving and Maintaining Compliance Using Continuous Monitoring Systems
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Optimizing the Sterilization of Liquids in Sealed Containers
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Using Modular Systems in Biopharmaceutical Manufacturing
PTebook_Genzyme185.jpg
Determining Protein Oxidation Induced During Fill-Finish Operations
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Single-Use Technology in Parenteral Fill/Finish

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