Vapor Phase Hydrogen Peroxide Decontamination or Sanitization of an Isolator for Aseptic Filling of Monoclonal Antibody Drug Product—Hydrogen Peroxide Uptake and Impact on Protein Quality

Aaron Hubbard; Thomas Roedl; 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 Decontamination or Sanitization of an Isolator for Aseptic Filling of Monoclonal Antibody Drug Product—Hydrogen Peroxide Uptake and Impact on Protein Quality

Aaron Hubbard, Thomas Roedl, Ada Hui, Stephanie Knueppel, Kirk Eppler, Siegfried Lehnert and Yuh-Fun Maa

PDA Journal of Pharmaceutical Science and Technology July 2018, 72 (4) 348-366; DOI: https://doi.org/10.5731/pdajpst.2017.008326

Aaron Hubbard

1Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, South San Francisco, CA;

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Thomas Roedl

2Manufacturing Science and Technology, F. Hoffmann-La Roche Ltd., Kaiseraugst, Switzerland; and

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Ada Hui

3Late Stage Pharmaceutical Development, Genentech, a member of the Roche Group, South San Francisco, CA

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Stephanie Knueppel

2Manufacturing Science and Technology, F. Hoffmann-La Roche Ltd., Kaiseraugst, Switzerland; and

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Kirk Eppler

1Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, South San Francisco, CA;

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Siegfried Lehnert

2Manufacturing Science and Technology, F. Hoffmann-La Roche Ltd., Kaiseraugst, Switzerland; and

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Yuh-Fun Maa

1Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, South San Francisco, CA;

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For correspondence: maay@gene.com

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vol. 72 no. 4 348-366

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

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Published online August 9, 2018.

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previous version (March 15, 2018 - 18:21).
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Author Information

Aaron Hubbard1,
Thomas Roedl2,
Ada Hui3,
Stephanie Knueppel2,
Kirk Eppler1,
Siegfried Lehnert2 and
Yuh-Fun Maa1,*

¹Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, South San Francisco, CA;
²Manufacturing Science and Technology, F. Hoffmann-La Roche Ltd., Kaiseraugst, Switzerland; and
³Late Stage Pharmaceutical Development, Genentech, a member of the Roche Group, South San Francisco, CA

↵* Corresponding Author: Yuh-Fun Maa, Genentech, a member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080. Telephone: +1-650-225-3499; Fax: +1-650-742-1504; e-mail: maay{at}gene.com

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Vapor Phase Hydrogen Peroxide Decontamination or Sanitization of an Isolator for Aseptic Filling of Monoclonal Antibody Drug Product—Hydrogen Peroxide Uptake and Impact on Protein Quality

Aaron Hubbard, Thomas Roedl, Ada Hui, Stephanie Knueppel, Kirk Eppler, Siegfried Lehnert, Yuh-Fun Maa

PDA Journal of Pharmaceutical Science and Technology Jul 2018, 72 (4) 348-366; DOI: 10.5731/pdajpst.2017.008326

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Vapor Phase Hydrogen Peroxide Decontamination or Sanitization of an Isolator for Aseptic Filling of Monoclonal Antibody Drug Product—Hydrogen Peroxide Uptake and Impact on Protein Quality

Aaron Hubbard, Thomas Roedl, Ada Hui, Stephanie Knueppel, Kirk Eppler, Siegfried Lehnert, Yuh-Fun Maa

PDA Journal of Pharmaceutical Science and Technology Jul 2018, 72 (4) 348-366; 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

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Keywords

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

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Vapor Phase Hydrogen Peroxide Decontamination or Sanitization of an Isolator for Aseptic Filling of Monoclonal Antibody Drug Product—Hydrogen Peroxide Uptake and Impact on Protein Quality

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