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Compendial Methods: Suitability Verification, Challenges and Recommendations for Proteins

Wen-Li Chung, Bruce Kabakoff, Jian Yin, Steven Messick, Miguel Saggu, Kate Tschudi, Rod Rahimi, Marianne Azarias and Connie Kong
PDA Journal of Pharmaceutical Science and Technology April 2020, pdajpst.2019.010652; DOI: https://doi.org/10.5731/pdajpst.2019.010652
Wen-Li Chung
Genentech/Roche
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  • For correspondence: chungw3@gene.com
Bruce Kabakoff
Genentech/Roche
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Jian Yin
Genentech/Roche
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Steven Messick
Genentech/Roche
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Miguel Saggu
Genentech/Roche
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Kate Tschudi
Genentech/Roche
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Rod Rahimi
Genentech/Roche
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  • For correspondence: rodrahimi@hotmail.com
Marianne Azarias
Genentech/Roche
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  • For correspondence: azarias.marianne@gene.com
Connie Kong
Genentech/Roche
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  • For correspondence: kong.connie@gene.com
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Article Information

pdajpst.2019.010652
DOI 
https://doi.org/10.5731/pdajpst.2019.010652
PubMed 
32295862

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Received July 29, 2019
  • Accepted March 5, 2020
  • Published online April 15, 2020.

Article Versions

  • You are currently viewing a previous version of this article (April 15, 2020 - 10:05).
  • View the most recent version of this article
Copyright & Usage 
Copyright © 2020, Parenteral Drug Association

Author Information

  1. Wen-Li Chung1 (chungw3{at}gene.com),
  2. Bruce Kabakoff (kabakoff.bruce{at}gene.com),
  3. Jian Yin (jian{at}gene.com),
  4. Steven Messick (messick.steven{at}gene.com),
  5. Miguel Saggu (saggu.miguel{at}gene.com),
  6. Kate Tschudi (tschudk1{at}gene.com),
  7. Rod Rahimi (rodrahimi{at}hotmail.com),
  8. Marianne Azarias (azarias.marianne{at}gene.com) and
  9. Connie Kong (kong.connie{at}gene.com)
  1. Genentech/Roche
  1. ↵* Corresponding author; email: chungw3{at}gene.com

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PDA Journal of Pharmaceutical Science and Technology: 79 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 1
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Compendial Methods: Suitability Verification, Challenges and Recommendations for Proteins
Wen-Li Chung, Bruce Kabakoff, Jian Yin, Steven Messick, Miguel Saggu, Kate Tschudi, Rod Rahimi, Marianne Azarias, Connie Kong
PDA Journal of Pharmaceutical Science and Technology Apr 2020, pdajpst.2019.010652; DOI: 10.5731/pdajpst.2019.010652

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Compendial Methods: Suitability Verification, Challenges and Recommendations for Proteins
Wen-Li Chung, Bruce Kabakoff, Jian Yin, Steven Messick, Miguel Saggu, Kate Tschudi, Rod Rahimi, Marianne Azarias, Connie Kong
PDA Journal of Pharmaceutical Science and Technology Apr 2020, pdajpst.2019.010652; DOI: 10.5731/pdajpst.2019.010652
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Keywords

  • Clarity/Opalescence
  • Compendial method suitability verification
  • Pharmacopeia, 21 CFR 211.194(a)(2), ANVISA, Partial Validation, Accuracy, Specificity, Precision
  • quality control
  • Visible Particulates and Sub-Vis Particles
  • pH, Osmolality, Color

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