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

doi:10.5731/pdajpst.2017.008326

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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;

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For correspondence: hubbard.aaron@gene.com

Thomas Reodl

2 Roche

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For correspondence: thomas.roedl@roche.com

Ada Hui

1 Genentech;

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For correspondence: hui.ada@gene.com

Stephanie Knueppel

2 Roche

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For correspondence: stephanie.knueppel@roche.com

Kirk Eppler

1 Genentech;

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For correspondence: eppler.kirk@gene.com

Siegfried Lehnert

2 Roche

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For correspondence: siegfried.lehnert@roche.com

Yuh-Fun Maa

1 Genentech;

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For correspondence: maay@gene.com

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Article Information

pdajpst.2017.008326

DOI

https://doi.org/10.5731/pdajpst.2017.008326

PubMed

29545321

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Received October 17, 2017
Accepted February 27, 2018
Published online March 15, 2018.

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Author Information

Aaron Hubbard1 (hubbard.aaron{at}gene.com),
Thomas Reodl2 (thomas.roedl{at}roche.com),
Ada Hui1 (hui.ada{at}gene.com),
Stephanie Knueppel2 (stephanie.knueppel{at}roche.com),
Kirk Eppler1 (eppler.kirk{at}gene.com),
Siegfried Lehnert2 (siegfried.lehnert{at}roche.com) and
Yuh-Fun Maa1,3 (maay{at}gene.com)

¹ Genentech;
² Roche

↵* Corresponding author; email: maay{at}gene.com

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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, 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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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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Development and Validation of a Customized Amplex UltraRed Assay for Sensitive Hydrogen Peroxide Detection in Pharmaceutical Water
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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

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Keywords

Drug product quality
monoclonal antibody
Quality by Design
VPHP uptake
Vapor phase hydrogen peroxide
Vaporized hydrogen peroxide

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