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Article CommentaryCommentary

Compendial Methods: Suitability Verification, Challenges and Recommendations for Proteins

Wen-Li Chung, Jian Yin, Steven Messick, Miguel Saggu, Kate Tschudi, Ann Woys, Rod Rahimi, Marianne Azarias, Connie Kong and Bruce Kabakoff
PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 581-591; DOI: https://doi.org/10.5731/pdajpst.2019.010652
Wen-Li Chung
Genentech/Roche, 1 DNA Way, South San Francisco, CA 94080.
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  • For correspondence: chungw3@gene.com
Jian Yin
Genentech/Roche, 1 DNA Way, South San Francisco, CA 94080.
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Steven Messick
Genentech/Roche, 1 DNA Way, South San Francisco, CA 94080.
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Miguel Saggu
Genentech/Roche, 1 DNA Way, South San Francisco, CA 94080.
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Kate Tschudi
Genentech/Roche, 1 DNA Way, South San Francisco, CA 94080.
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Ann Woys
Genentech/Roche, 1 DNA Way, South San Francisco, CA 94080.
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Rod Rahimi
Genentech/Roche, 1 DNA Way, South San Francisco, CA 94080.
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Marianne Azarias
Genentech/Roche, 1 DNA Way, South San Francisco, CA 94080.
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Connie Kong
Genentech/Roche, 1 DNA Way, South San Francisco, CA 94080.
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Bruce Kabakoff
Genentech/Roche, 1 DNA Way, South San Francisco, CA 94080.
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Abstract

Compendial testing methods are not required to be fully validated, but their suitability for testing should be verified under actual conditions of use. This requirement is established in 21 CFR 211.194(a)(2) of the current Good Manufacturing Practice regulations in the United States. ANVISA (Agência Nacional de Vigilância Sanitária) also requires that compendial analytical methods shall have their suitability demonstrated for the intended use by a partial validation study. Suitability verifications or partial validation can be divided into two major categories: visual and instrumental methods. For visual methods, the color and opalescence of interferences should be checked. If the color or clarity/opalescence of the sample is outside of the range of the Pharmacopeia standards/reference solutions, the validity of the test results should be evaluated. Specificity is usually waived because the methods are not specific to products, and accuracy/precision can be addressed by comparing results from analyst to analyst. For instrument methods, specificity can also be waived for certain assays. Accuracy is addressed by implementation of instrument calibration and/or method control. Precision is required either in suitability verification or when testing the samples. Here, we present approaches for suitability verification and the scientific rationale supporting compendial methods: visible particulates, subvisible particles, pH, osmolality, color and clarity/opalescence. Current challenges and recommendations are also discussed specifically for the analysis of protein products.

  • Compendial method suitability verification
  • Pharmacopoeia
  • 21 CFR 211.194(a)(2)
  • ANVISA
  • Partial validation
  • Accuracy
  • Specificity
  • Precision
  • Visible particulates
  • Sub-Vis Particles
  • pH
  • Osmolality
  • Color and Clarity/Opalescence
  • © PDA, Inc. 2020
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PDA Journal of Pharmaceutical Science and Technology: 74 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 5
September/October 2020
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Compendial Methods: Suitability Verification, Challenges and Recommendations for Proteins
Wen-Li Chung, Jian Yin, Steven Messick, Miguel Saggu, Kate Tschudi, Ann Woys, Rod Rahimi, Marianne Azarias, Connie Kong, Bruce Kabakoff
PDA Journal of Pharmaceutical Science and Technology Sep 2020, 74 (5) 581-591; DOI: 10.5731/pdajpst.2019.010652
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Keywords

  • Compendial method suitability verification
  • Pharmacopoeia
  • 21 CFR 211.194(a)(2)
  • ANVISA
  • Partial validation
  • Accuracy
  • Specificity
  • Precision
  • Visible particulates
  • Sub-Vis Particles
  • pH
  • Osmolality
  • Color and Clarity/Opalescence

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Compendial Methods: Suitability Verification, Challenges and Recommendations for Proteins
Wen-Li Chung, Jian Yin, Steven Messick, Miguel Saggu, Kate Tschudi, Ann Woys, Rod Rahimi, Marianne Azarias, Connie Kong, Bruce Kabakoff
PDA Journal of Pharmaceutical Science and Technology Sep 2020, 74 (5) 581-591; DOI: 10.5731/pdajpst.2019.010652

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