Stability Evaluation of Hydrogen Peroxide Uptake Samples from Monoclonal Antibody Drug Product Aseptically Filled in VPHP-Sanitized Barrier Systems

Devon Roshan Eisner; Ada Hui; Kirk Eppler; Vassia Tegoulia; Yuh-Fun Maa

doi:10.5731/pdajpst.2018.009340

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Stability Evaluation of Hydrogen Peroxide Uptake Samples from Monoclonal Antibody Drug Product Aseptically Filled in VPHP-Sanitized Barrier Systems

Devon Roshan Eisner, Ada Hui, Kirk Eppler, Vassia Tegoulia and Yuh-Fun Maa

PDA Journal of Pharmaceutical Science and Technology January 2019, pdajpst.2018.009340; DOI: https://doi.org/10.5731/pdajpst.2018.009340

Devon Roshan Eisner

Genentech

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For correspondence: roshan-eisner.devon@gene.com

Ada Hui

Genentech

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For correspondence: hui.ada@gene.com

Kirk Eppler

Genentech

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For correspondence: eppler.kirk@gene.com

Vassia Tegoulia

Genentech

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For correspondence: tegoulia.vassia@gene.com

Yuh-Fun Maa

Genentech

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For correspondence: maay@gene.com

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Article Information

pdajpst.2018.009340

DOI

https://doi.org/10.5731/pdajpst.2018.009340

PubMed

30651338

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Received August 30, 2018
Accepted December 13, 2018
Published online January 16, 2019.

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Author Information

Devon Roshan Eisner (roshan-eisner.devon{at}gene.com),
Ada Hui (hui.ada{at}gene.com),
Kirk Eppler (eppler.kirk{at}gene.com),
Vassia Tegoulia (tegoulia.vassia{at}gene.com) and
Yuh-Fun Maa 1 (maay{at}gene.com)

Genentech

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

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Stability Evaluation of Hydrogen Peroxide Uptake Samples from Monoclonal Antibody Drug Product Aseptically Filled in VPHP-Sanitized Barrier Systems

Devon Roshan Eisner, Ada Hui, Kirk Eppler, Vassia Tegoulia, Yuh-Fun Maa

PDA Journal of Pharmaceutical Science and Technology Jan 2019, pdajpst.2018.009340; DOI: 10.5731/pdajpst.2018.009340

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Stability Evaluation of Hydrogen Peroxide Uptake Samples from Monoclonal Antibody Drug Product Aseptically Filled in VPHP-Sanitized Barrier Systems

Devon Roshan Eisner, Ada Hui, Kirk Eppler, Vassia Tegoulia, Yuh-Fun Maa

PDA Journal of Pharmaceutical Science and Technology Jan 2019, pdajpst.2018.009340; DOI: 10.5731/pdajpst.2018.009340

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Keywords

H2O2 decomposition
Hydrogen peroxide (H2O2)
monoclonal antibody
VPHP uptake
Vapor phase hydrogen peroxide (VPHP)

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Stability Evaluation of Hydrogen Peroxide Uptake Samples from Monoclonal Antibody Drug Product Aseptically Filled in VPHP-Sanitized Barrier Systems

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