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Vapor Phase Hydrogen Peroxide Sanitization of an Isolator for Aseptic Filling of Monoclonal Antibody Drug Product - Hydrogen Peroxide Uptake and Impact on Protein Quality
Aaron Hubbard, Thomas Reodl, Ada Hui, Stephanie Knueppel, Kirk Eppler, Siegfried Lehnert and Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology March 2018, pdajpst.2017.008326; DOI: https://doi.org/10.5731/pdajpst.2017.008326
Aaron Hubbard
1 Genentech;
Thomas Reodl
2 Roche
Ada Hui
1 Genentech;
Stephanie Knueppel
2 Roche
Kirk Eppler
1 Genentech;
Siegfried Lehnert
2 Roche
Yuh-Fun Maa
1 Genentech;
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 1
January/February 2025
Vapor Phase Hydrogen Peroxide Sanitization of an Isolator for Aseptic Filling of Monoclonal Antibody Drug Product - Hydrogen Peroxide Uptake and Impact on Protein Quality
Aaron Hubbard, Thomas Reodl, Ada Hui, Stephanie Knueppel, Kirk Eppler, Siegfried Lehnert, Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology Mar 2018, pdajpst.2017.008326; DOI: 10.5731/pdajpst.2017.008326
Vapor Phase Hydrogen Peroxide Sanitization of an Isolator for Aseptic Filling of Monoclonal Antibody Drug Product - Hydrogen Peroxide Uptake and Impact on Protein Quality
Aaron Hubbard, Thomas Reodl, Ada Hui, Stephanie Knueppel, Kirk Eppler, Siegfried Lehnert, Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology Mar 2018, pdajpst.2017.008326; DOI: 10.5731/pdajpst.2017.008326
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- Stability Evaluation of Hydrogen Peroxide Uptake Samples from Monoclonal Antibody Drug Product Aseptically Filled in Vapor Phase Hydrogen Peroxide-Sanitized Barrier Systems: A Case Study