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OtherCase Studies

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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PDA Journal of Pharmaceutical Science and Technology: 79 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 3
May/June 2025
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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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  • Development and Validation of a Customized Amplex UltraRed Assay for Sensitive Hydrogen Peroxide Detection in Pharmaceutical Water
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  • Phase-Incremental Decision Trees for Multi-Phase Feature Selection and Interaction in Biologics Manufacturing
  • Practical Application of Setting up an Annual Contamination Control Strategy (CCS) Assessment
  • A Risk Assessment and Risk Based Approach Review of Pre-use/Post Sterilization Integrity Testing (PUPSIT)
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Keywords

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

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