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OtherCommentary

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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PDA Journal of Pharmaceutical Science and Technology: 79 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 1
January/February 2025
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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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Cited By...

  • Advancing Biologics Development Programs with Legacy Cell Lines: Advantages and Limitations of Genetic Testing for Addressing Clonality Concerns Prior to Availability of Late Stage Process and Product Consistency Data
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Keywords

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

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