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Article CommentaryCommentary

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 Qian, Qingxiang Wei, Michael W. Laird, Yuan Zhu, Robyn Emmins, John A. Follit, Alison Porter, Andrew J. Racher, Sarah Milne, Ivan Carubelli, Zhimei Du, Ankita Khatri, Marilyne Failly, Hervé Broly, Frank Lee, Matthew Reeser, Jared Spidel, Karin Anderson, Christine Demaria, Jennifer Di-Carlo, John Gill, Amie Lundquist, Sampath R. Kumar and Tony Gill
PDA Journal of Pharmaceutical Science and Technology July 2018, 72 (4) 438-450; DOI: https://doi.org/10.5731/pdajpst.2018.008789
Kyle Zingaro
1Alexion Pharmaceuticals, Inc., New Haven, CT, USA;
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  • For correspondence: kyle.zingaro@gmail.com david.shaw@gene.com
David Shaw
2Genentech, Inc., South San Francisco, CA, USA;
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  • For correspondence: kyle.zingaro@gmail.com david.shaw@gene.com
Jerry Carson
3AbbVie Bioresearch Center, Worcester, MA, USA;
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Anke Mayer-Bartschmid
4Bayer AG, Pharmaceuticals, Research and Development, Cell and Protein Sciences, Wuppertal, Germany;
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Christian Bender
4Bayer AG, Pharmaceuticals, Research and Development, Cell and Protein Sciences, Wuppertal, Germany;
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Christina Alves
5Biogen, Cell Culture Development, Cambridge, MA, USA;
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Duncan Mcvey
6Bristol-Myers Squibb, Pennington, NJ, USA;
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Nan-Xin Qian
7Bristol-Myers Squibb, Devens, MA, USA;
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Qingxiang Wei
8Celgene Corporation, Summit West, Summit, NJ, USA;
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Michael W. Laird
2Genentech, Inc., South San Francisco, CA, USA;
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Yuan Zhu
9GSK, King of Prussia, PA, USA;
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Robyn Emmins
10GSK, Stevenage, UK;
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John A. Follit
11ImmunoGen, Inc., Waltham, USA;
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Alison Porter
12Lonza Biologics plc, Slough, UK;
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Andrew J. Racher
12Lonza Biologics plc, Slough, UK;
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Sarah Milne
12Lonza Biologics plc, Slough, UK;
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Ivan Carubelli
12Lonza Biologics plc, Slough, UK;
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Zhimei Du
13Merck & Co., Inc., Kenilworth, NJ, USA;
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Ankita Khatri
13Merck & Co., Inc., Kenilworth, NJ, USA;
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Marilyne Failly
14Merck Biodevelopment, Martillac, France;
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Hervé Broly
15Merck Serono S.A., Fenil-sur-Corsier, Switzerland;
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Frank Lee
16Morphotek, Inc., Exton, PA, USA;
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Matthew Reeser
16Morphotek, Inc., Exton, PA, USA;
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Jared Spidel
16Morphotek, Inc., Exton, PA, USA;
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Karin Anderson
17Pfizer BioTherapeutics Pharmaceutical Sciences, Andover, MA, USA;
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Christine Demaria
18Sanofi Biopharmaceutics Development, Framingham, MA USA;
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Jennifer Di-Carlo
19Sanofi Biopharmaceutics Development, Vitry-sur-Seine, France;
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John Gill
20Shire, Lexington, MA, USA;
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Amie Lundquist
20Shire, Lexington, MA, USA;
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Sampath R. Kumar
21Takeda Pharmaceuticals International Co., Cambridge, MA, USA; and
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Tony Gill
22BioPhorum Development Group, Sheffield, UK
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Article Information

vol. 72 no. 4 438-450
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 
  • Published online August 9, 2018.

Article Versions

  • previous version (April 18, 2018 - 16:57).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2018

Author Information

  1. Kyle Zingaro1,*,
  2. David Shaw2,*,
  3. Jerry Carson3,
  4. Anke Mayer-Bartschmid4,
  5. Christian Bender4,
  6. Christina Alves5,
  7. Duncan Mcvey6,
  8. Nan-Xin Qian7,
  9. Qingxiang Wei8,
  10. Michael W. Laird2,
  11. Yuan Zhu9,
  12. Robyn Emmins10,
  13. John A. Follit11,
  14. Alison Porter12,
  15. Andrew J. Racher12,
  16. Sarah Milne12,
  17. Ivan Carubelli12,
  18. Zhimei Du13,
  19. Ankita Khatri13,
  20. Marilyne Failly14,
  21. Hervé Broly15,
  22. Frank Lee16,
  23. Matthew Reeser16,
  24. Jared Spidel16,
  25. Karin Anderson17,
  26. Christine Demaria18,
  27. Jennifer Di-Carlo19,
  28. John Gill20,
  29. Amie Lundquist20,
  30. Sampath R. Kumar21 and
  31. Tony Gill22
  1. 1Alexion Pharmaceuticals, Inc., New Haven, CT, USA;
  2. 2Genentech, Inc., South San Francisco, CA, USA;
  3. 3AbbVie Bioresearch Center, Worcester, MA, USA;
  4. 4Bayer AG, Pharmaceuticals, Research and Development, Cell and Protein Sciences, Wuppertal, Germany;
  5. 5Biogen, Cell Culture Development, Cambridge, MA, USA;
  6. 6Bristol-Myers Squibb, Pennington, NJ, USA;
  7. 7Bristol-Myers Squibb, Devens, MA, USA;
  8. 8Celgene Corporation, Summit West, Summit, NJ, USA;
  9. 9GSK, King of Prussia, PA, USA;
  10. 10GSK, Stevenage, UK;
  11. 11ImmunoGen, Inc., Waltham, USA;
  12. 12Lonza Biologics plc, Slough, UK;
  13. 13Merck & Co., Inc., Kenilworth, NJ, USA;
  14. 14Merck Biodevelopment, Martillac, France;
  15. 15Merck Serono S.A., Fenil-sur-Corsier, Switzerland;
  16. 16Morphotek, Inc., Exton, PA, USA;
  17. 17Pfizer BioTherapeutics Pharmaceutical Sciences, Andover, MA, USA;
  18. 18Sanofi Biopharmaceutics Development, Framingham, MA USA;
  19. 19Sanofi Biopharmaceutics Development, Vitry-sur-Seine, France;
  20. 20Shire, Lexington, MA, USA;
  21. 21Takeda Pharmaceuticals International Co., Cambridge, MA, USA; and
  22. 22BioPhorum Development Group, Sheffield, UK
  1. ↵* Corresponding Authors: Kyle Zingaro, Alexion Pharmaceuticals, Inc., 100 College Street, New Haven, CT 06510, USA. Telephone: +1 475 230 2273; e-mail: kyle.zingaro{at}gmail.com; David Shaw, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA. Telephone: +1 650 467 7336; e-mail: david.shaw{at}gene.com
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PDA Journal of Pharmaceutical Science and Technology: 72 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 4
July/August 2018
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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 Qian, Qingxiang Wei, Michael W. Laird, Yuan Zhu, Robyn Emmins, John A. Follit, Alison Porter, Andrew J. Racher, Sarah Milne, Ivan Carubelli, Zhimei Du, Ankita Khatri, Marilyne Failly, Hervé Broly, Frank Lee, Matthew Reeser, Jared Spidel, Karin Anderson, Christine Demaria, Jennifer Di-Carlo, John Gill, Amie Lundquist, Sampath R. Kumar, Tony Gill
PDA Journal of Pharmaceutical Science and Technology Jul 2018, 72 (4) 438-450; 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 Qian, Qingxiang Wei, Michael W. Laird, Yuan Zhu, Robyn Emmins, John A. Follit, Alison Porter, Andrew J. Racher, Sarah Milne, Ivan Carubelli, Zhimei Du, Ankita Khatri, Marilyne Failly, Hervé Broly, Frank Lee, Matthew Reeser, Jared Spidel, Karin Anderson, Christine Demaria, Jennifer Di-Carlo, John Gill, Amie Lundquist, Sampath R. Kumar, Tony Gill
PDA Journal of Pharmaceutical Science and Technology Jul 2018, 72 (4) 438-450; DOI: 10.5731/pdajpst.2018.008789
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  • Article
    • Abstract
    • Introduction
    • Considerations for Implementation of Plate Imaging
    • Case Studies in Plate-Based Imager Verification
    • Approaches to Addressing Regulatory Requirements for Clonal Cell Lines
    • Conclusions
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Keywords

  • monoclonality
  • cell cloning
  • clonally derived
  • limited/limiting dilution
  • Plate-based imaging
  • Single-cell imaging
  • CHO

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