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Article CommentaryCommentary

Biopharmaceutical Industry Practices for Sequence Variant Analyses of Recombinant Protein Therapeutics

John Valliere-Douglass, Lisa Marzilli, Aparna Deora, Zhimei Du, Luhong He, Sampath R. Kumar, Yan-Hui Liu, Hans-Martin Mueller, Charles Nwosu, John Stults, Yan Wang, Sam Yaghmour and Yizhou Zhou
PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 622-634; DOI: https://doi.org/10.5731/pdajpst.2019.010009
John Valliere-Douglass
1Seattle Genetics Inc., Bothell, WA;
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  • For correspondence: jdouglass@seagen.com
Lisa Marzilli
2Pfizer Inc., Andover, MA;
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Aparna Deora
3Pfizer Inc., Chesterfield, MO;
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Zhimei Du
4Merck & Co., Inc., Kenilworth, NJ;
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Luhong He
5Eli Lilly & Company, Indianapolis, IN;
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Sampath R. Kumar
6Takeda Pharmaceuticals, Cambridge, MA;
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Yan-Hui Liu
4Merck & Co., Inc., Kenilworth, NJ;
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Hans-Martin Mueller
7Merck Sharp & Dohme AG, Lucerne, Switzerland;
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Charles Nwosu
6Takeda Pharmaceuticals, Cambridge, MA;
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John Stults
8Genentech Inc., South San Francisco, CA;
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Yan Wang
10Takeda Pharmaceuticals, Lexington, MA; and
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Sam Yaghmour
11Amgen Inc., Thousand Oaks, CA
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Yizhou Zhou
9Biogen Inc., Cambridge, MA;
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 73 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 6
November/December 2019
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Biopharmaceutical Industry Practices for Sequence Variant Analyses of Recombinant Protein Therapeutics
John Valliere-Douglass, Lisa Marzilli, Aparna Deora, Zhimei Du, Luhong He, Sampath R. Kumar, Yan-Hui Liu, Hans-Martin Mueller, Charles Nwosu, John Stults, Yan Wang, Sam Yaghmour, Yizhou Zhou
PDA Journal of Pharmaceutical Science and Technology Nov 2019, 73 (6) 622-634; DOI: 10.5731/pdajpst.2019.010009
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  • Article
    • Abstract
    • Introduction
    • Survey Methodology and Scope
    • Summary of the Survey Results
    • Mass Spectrometry (MS)
    • Next-Generation Sequencing
    • Discussion
    • Conclusion
    • Conflict of Interest Declaration
    • Acknowledgements
    • Appendix
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  • Addressing Medical Device Extractables and Leachables via Non-Target Analysis (NTA); The Analytical Evaluation Threshold (AET) and Quantitation
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Keywords

  • Amino acid sequence variants
  • Amino acid substitution
  • Codon wobble
  • Mass spectrometry
  • Next-generation sequencing
  • Clone screening

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Biopharmaceutical Industry Practices for Sequence Variant Analyses of Recombinant Protein Therapeutics
John Valliere-Douglass, Lisa Marzilli, Aparna Deora, Zhimei Du, Luhong He, Sampath R. Kumar, Yan-Hui Liu, Hans-Martin Mueller, Charles Nwosu, John Stults, Yan Wang, Sam Yaghmour, Yizhou Zhou
PDA Journal of Pharmaceutical Science and Technology Nov 2019, 73 (6) 622-634; DOI: 10.5731/pdajpst.2019.010009

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