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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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  • For correspondence: saggu.miguel@gene.com
Kate Tschudi
Genentech/Roche
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  • For correspondence: tschudk1@gene.com
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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PDA Journal of Pharmaceutical Science and Technology: 79 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 1
January/February 2025
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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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More in this TOC Section

  • Retrospective Evaluation of Cycled Resin in Viral Clearance Studies - A Multiple Company Collaboration - Post ICH Q5A(R2) Review
  • Addressing Medical Device Extractables and Leachables via Non-Target Analysis (NTA); The Analytical Evaluation Threshold (AET) and Quantitation
  • Expanding the Use of Moist Heat for Terminal Sterilization
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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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