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Implementation of Plate Imaging for Demonstration of Monoclonality in Biologics Manufacturing Development

Kyle Zingaro, David Shaw, Jerry Carson, Anke Mayer-Bartschmid, Christian Bender, Christina Alves, Duncan McVey, Nan-xin Quan, Quinxiang Wei, Mike Laird, Yuan Zhu, Robyn Emmins, John Follit, Alison Porter, Andrew J Racher, Sarah Milne, Ivan Carubelli, Zhimei Du, Ankita Khatri, Marilyne Failly, Herve Broly, Frank Lee, Matthew Reeser, Jared Spirel, Karin Anderson, Christine DeMaria, Jennifer Di-Carlo, John Gill, Amie Lundquist, Sampath R Kumar and Tony Gill
PDA Journal of Pharmaceutical Science and Technology April 2018, pdajpst.2018.008789; DOI: https://doi.org/10.5731/pdajpst.2018.008789
Kyle Zingaro
1 Alexion;
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  • For correspondence: kyle.zingaro@alexion.com
David Shaw
2 Genetech;
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Jerry Carson
3 AbbVie;
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Anke Mayer-Bartschmid
4 Bayer AG;
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Christian Bender
5 Bayer;
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Christina Alves
6 Biogen;
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Duncan McVey
7 Bristol-Myers Squibb;
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Nan-xin Quan
8 Bristol-Meyers Squibb;
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Quinxiang Wei
9 Celgene;
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Mike Laird
2 Genetech;
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Yuan Zhu
10 GSK;
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Robyn Emmins
10 GSK;
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John Follit
11 ImmunGen Inc;
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Alison Porter
12 Lonza Biologics PLC;
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Andrew J Racher
12 Lonza Biologics PLC;
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Sarah Milne
12 Lonza Biologics PLC;
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Ivan Carubelli
12 Lonza Biologics PLC;
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Zhimei Du
13 Merck & Co;
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Ankita Khatri
13 Merck & Co;
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Marilyne Failly
14 Merck Biodevelopment;
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Herve Broly
15 Merck Serono;
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Frank Lee
16 Morphotek Inc;
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Matthew Reeser
16 Morphotek Inc;
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Jared Spirel
16 Morphotek Inc;
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Karin Anderson
17 Pfizer BIoTherapeutics Pharmaecutical Sciences;
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Christine DeMaria
18 Sanofi Biopharmaceutics Development;
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Jennifer Di-Carlo
18 Sanofi Biopharmaceutics Development;
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John Gill
19 Shire;
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Amie Lundquist
19 Shire;
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Sampath R Kumar
20 Takeda Pharmaceuticals International Co;
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Tony Gill
21 BioPhorum Development Group
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Article Information

pdajpst.2018.008789
DOI 
https://doi.org/10.5731/pdajpst.2018.008789
PubMed 
29669815

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Received February 28, 2018
  • Accepted March 8, 2018
  • Published online April 18, 2018.

Article Versions

  • You are currently viewing a previous version of this article (April 18, 2018 - 16:57).
  • View the most recent version of this article
Copyright & Usage 
Copyright © 2018, Parenteral Drug Association

Author Information

  1. Kyle Zingaro1,22 (kyle.zingaro{at}alexion.com),
  2. David Shaw2,
  3. Jerry Carson3,
  4. Anke Mayer-Bartschmid4,
  5. Christian Bender5,
  6. Christina Alves6,
  7. Duncan McVey7,
  8. Nan-xin Quan8,
  9. Quinxiang Wei9,
  10. Mike Laird2,
  11. Yuan Zhu10,
  12. Robyn Emmins10,
  13. John Follit11,
  14. Alison Porter12,
  15. Andrew J Racher12,
  16. Sarah Milne12,
  17. Ivan Carubelli12,
  18. Zhimei Du13,
  19. Ankita Khatri13,
  20. Marilyne Failly14,
  21. Herve Broly15,
  22. Frank Lee16,
  23. Matthew Reeser16,
  24. Jared Spirel16,
  25. Karin Anderson17,
  26. Christine DeMaria18,
  27. Jennifer Di-Carlo18,
  28. John Gill19,
  29. Amie Lundquist19,
  30. Sampath R Kumar20 and
  31. Tony Gill21
  1. 1 Alexion;
  2. 2 Genetech;
  3. 3 AbbVie;
  4. 4 Bayer AG;
  5. 5 Bayer;
  6. 6 Biogen;
  7. 7 Bristol-Myers Squibb;
  8. 8 Bristol-Meyers Squibb;
  9. 9 Celgene;
  10. 10 GSK;
  11. 11 ImmunGen Inc;
  12. 12 Lonza Biologics PLC;
  13. 13 Merck & Co;
  14. 14 Merck Biodevelopment;
  15. 15 Merck Serono;
  16. 16 Morphotek Inc;
  17. 17 Pfizer BIoTherapeutics Pharmaecutical Sciences;
  18. 18 Sanofi Biopharmaceutics Development;
  19. 19 Shire;
  20. 20 Takeda Pharmaceuticals International Co;
  21. 21 BioPhorum Development Group
  1. ↵* Corresponding author; email: kyle.zingaro{at}alexion.com

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PDA Journal of Pharmaceutical Science and Technology: 79 (1)
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Implementation of Plate Imaging for Demonstration of Monoclonality in Biologics Manufacturing Development
Kyle Zingaro, David Shaw, Jerry Carson, Anke Mayer-Bartschmid, Christian Bender, Christina Alves, Duncan McVey, Nan-xin Quan, Quinxiang Wei, Mike Laird, Yuan Zhu, Robyn Emmins, John Follit, Alison Porter, Andrew J Racher, Sarah Milne, Ivan Carubelli, Zhimei Du, Ankita Khatri, Marilyne Failly, Herve Broly, Frank Lee, Matthew Reeser, Jared Spirel, Karin Anderson, Christine DeMaria, Jennifer Di-Carlo, John Gill, Amie Lundquist, Sampath R Kumar, Tony Gill
PDA Journal of Pharmaceutical Science and Technology Apr 2018, pdajpst.2018.008789; DOI: 10.5731/pdajpst.2018.008789

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Implementation of Plate Imaging for Demonstration of Monoclonality in Biologics Manufacturing Development
Kyle Zingaro, David Shaw, Jerry Carson, Anke Mayer-Bartschmid, Christian Bender, Christina Alves, Duncan McVey, Nan-xin Quan, Quinxiang Wei, Mike Laird, Yuan Zhu, Robyn Emmins, John Follit, Alison Porter, Andrew J Racher, Sarah Milne, Ivan Carubelli, Zhimei Du, Ankita Khatri, Marilyne Failly, Herve Broly, Frank Lee, Matthew Reeser, Jared Spirel, Karin Anderson, Christine DeMaria, Jennifer Di-Carlo, John Gill, Amie Lundquist, Sampath R Kumar, Tony Gill
PDA Journal of Pharmaceutical Science and Technology Apr 2018, pdajpst.2018.008789; DOI: 10.5731/pdajpst.2018.008789
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Keywords

  • cell cloning
  • clonally derived
  • limited/limiting dilution
  • monoclonality
  • plate based imaging
  • single cell imaging

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