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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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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
    • Conflict of Interest Declaration
    • Acknowledgements
    • Reference
  • Figures & Data
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  • References
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Keywords

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

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