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OtherCommentary

Biopharmaceutical Industry Practices for Sequence Variant Analyses of Recombinant Protein Therapeutics

John Valliere-Douglass, Lisa Marzilli, Aparna Deora, Zhimei Du, Luhong He, Sampath 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 June 2019, pdajpst.2019.010009; DOI: https://doi.org/10.5731/pdajpst.2019.010009
John Valliere-Douglass
1 Seattle Genetics Inc.;
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  • For correspondence: jdouglass@seagen.com
Lisa Marzilli
2 Pfizer;
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  • For correspondence: lisa.marzilli@pfizer.com
Aparna Deora
2 Pfizer;
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  • For correspondence: aparna.deora@pfizer.com
Zhimei Du
3 Merck;
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  • For correspondence: zhimei.du@merck.com
Luhong He
4 Eli Lilly;
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  • For correspondence: he_luhong@lilly.com
Sampath Kumar
5 Takeda;
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  • For correspondence: sampath.kumar@takeda.com
Yan-Hui Liu
3 Merck;
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  • For correspondence: yan-hui.liu@merck.com
Hans Martin-Mueller
3 Merck;
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  • For correspondence: hans-martin.mueller@merck.com
Charles Nwosu
5 Takeda;
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  • For correspondence: charles.nwosu2@takeda.com
John Stults
6 Genentech;
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  • For correspondence: stults.john@gene.com
Yan Wang
7 Shire;
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  • For correspondence: yan.wang@shire.com
Sam Yaghmour
8 Amgen;
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  • For correspondence: samihy@amgen.com
Yizhou Zhou
9 Biogen
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  • For correspondence: yizhou.zhou@biogen.com
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Article Information

pdajpst.2019.010009
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 
  • Received January 25, 2019
  • Accepted June 5, 2019
  • Published online June 17, 2019.

Article Versions

  • You are currently viewing a previous version of this article (June 17, 2019 - 04:45).
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Copyright & Usage 
Copyright © 2019, Parenteral Drug Association

Author Information

  1. John Valliere-Douglass1,10 (jdouglass{at}seagen.com),
  2. Lisa Marzilli2 (lisa.marzilli{at}pfizer.com),
  3. Aparna Deora2 (aparna.deora{at}pfizer.com),
  4. Zhimei Du3 (zhimei.du{at}merck.com),
  5. Luhong He4 (he_luhong{at}lilly.com),
  6. Sampath Kumar5 (sampath.kumar{at}takeda.com),
  7. Yan-Hui Liu3 (yan-hui.liu{at}merck.com),
  8. Hans Martin-Mueller3 (hans-martin.mueller{at}merck.com),
  9. Charles Nwosu5 (charles.nwosu2{at}takeda.com),
  10. John Stults6 (stults.john{at}gene.com),
  11. Yan Wang7 (yan.wang{at}shire.com),
  12. Sam Yaghmour8 (samihy{at}amgen.com) and
  13. Yizhou Zhou9 (yizhou.zhou{at}biogen.com)
  1. 1 Seattle Genetics Inc.;
  2. 2 Pfizer;
  3. 3 Merck;
  4. 4 Eli Lilly;
  5. 5 Takeda;
  6. 6 Genentech;
  7. 7 Shire;
  8. 8 Amgen;
  9. 9 Biogen
  1. ↵* Corresponding author; email: jdouglass{at}seagen.com

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PDA Journal of Pharmaceutical Science and Technology: 79 (3)
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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 Kumar, Yan-Hui Liu, Hans Martin-Mueller, Charles Nwosu, John Stults, Yan Wang, Sam Yaghmour, Yizhou Zhou
PDA Journal of Pharmaceutical Science and Technology Jun 2019, pdajpst.2019.010009; 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 Kumar, Yan-Hui Liu, Hans Martin-Mueller, Charles Nwosu, John Stults, Yan Wang, Sam Yaghmour, Yizhou Zhou
PDA Journal of Pharmaceutical Science and Technology Jun 2019, pdajpst.2019.010009; DOI: 10.5731/pdajpst.2019.010009
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Keywords

  • Amino acid sequence variants
  • Amino Acid Substitutions
  • Clone screening
  • Codon wobble
  • Mass spectrometry
  • Next Generation Sequencing

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