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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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  • Article
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Article Information

vol. 73 no. 6 622-634
DOI 
https://doi.org/10.5731/pdajpst.2019.010009
PubMed 
31209169

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online December 10, 2019.

Article Versions

  • previous version (June 17, 2019 - 04:45).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2019

Author Information

  1. John Valliere-Douglass1,*,
  2. Lisa Marzilli2,
  3. Aparna Deora3,
  4. Zhimei Du4,
  5. Luhong He5,
  6. Sampath R. Kumar6,
  7. Yan-Hui Liu4,
  8. Hans-Martin Mueller7,
  9. Charles Nwosu6,
  10. John Stults8,
  11. Yan Wang10,
  12. Sam Yaghmour11 and
  13. Yizhou Zhou9
  1. 1Seattle Genetics Inc., Bothell, WA;
  2. 2Pfizer Inc., Andover, MA;
  3. 3Pfizer Inc., Chesterfield, MO;
  4. 4Merck & Co., Inc., Kenilworth, NJ;
  5. 5Eli Lilly & Company, Indianapolis, IN;
  6. 6Takeda Pharmaceuticals, Cambridge, MA;
  7. 7Merck Sharp & Dohme AG, Lucerne, Switzerland;
  8. 8Genentech Inc., South San Francisco, CA;
  9. 9Biogen Inc., Cambridge, MA;
  10. 10Takeda Pharmaceuticals, Lexington, MA; and
  11. 11Amgen Inc., Thousand Oaks, CA
  1. ↵* Corresponding Author: Seattle Genetics, Inc., 22515 29th Dr SE, Bothell, WA 98021; Telephone: (425) 527-2412; E-mail: jdouglass{at}seagen.com
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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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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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Keywords

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

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