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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

Paul Wu, Taymar Hartman, Louise Almond, Jennitte Stevens, John Thrift, Juhi Ojha, Christina Alves, David Shaw, Michael W. Laird, Robyn Emmins, Yuan Zhu, Ren Liu, Zhimei Du, Rolf Koehler, Thomas Jostock, Karin Anderson, Chris Campbell and Howard Clarke
PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316

Article Information

vol. 74 no. 2 264-274
DOI 
https://doi.org/10.5731/pdajpst.2018.009316
PubMed 
31519780
Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online April 9, 2020.

Article Versions

Copyright & Usage 
© PDA, Inc. 2020

Author Information

  1. Paul Wu1,*,
  2. Taymar Hartman2,
  3. Louise Almond3,
  4. Jennitte Stevens4,
  5. John Thrift1,
  6. Juhi Ojha1,
  7. Christina Alves5,
  8. David Shaw6,
  9. Michael W. Laird6,
  10. Robyn Emmins7,
  11. Yuan Zhu7,
  12. Ren Liu8,
  13. Zhimei Du8,
  14. Rolf Koehler9,
  15. Thomas Jostock9,
  16. Karin Anderson10,
  17. Chris Campbell11,# and
  18. Howard Clarke12
  1. 1Bayer HealthCare LLC, Berkeley, CA;
  2. 2Abbvie Biotherapeutics Inc., Redwood City, CA;
  3. 3Allergan Biologics Ltd., Liverpool, UK;
  4. 4Amgen Inc., Thousand Oaks, CA;
  5. 5Biogen Inc., Cambridge, MA;
  6. 6Genentech Inc., South San Francisco, CA;
  7. 7GSK, King of Prussia, PA; Stevenage, UK;
  8. 8Merck & Co., Inc., Kenilworth, NJ;
  9. 9Novartis Pharma AG, Basel, Switzerland;
  10. 10Pfizer Inc., Andover, MA;
  11. 11Takeda Pharmaceuticals, Cambridge, MA; and
  12. 12Seattle Genetics Inc., Bothell, WA
  1. ↵*Corresponding Author: Paul Wu, Bayer HealthCare LLC, Berkeley, CA 94710, e-mail: paul.wu{at}bayer.com

  • ↵# Current affiliation: Sarepta Therapeutics, Cambridge, MA, USA.

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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
Paul Wu, Taymar Hartman, Louise Almond, Jennitte Stevens, John Thrift, Juhi Ojha, Christina Alves, David Shaw, Michael W. Laird, Robyn Emmins, Yuan Zhu, Ren Liu, Zhimei Du, Rolf Koehler, Thomas Jostock, Karin Anderson, Chris Campbell, Howard Clarke
PDA Journal of Pharmaceutical Science and Technology Mar 2020, 74 (2) 264-274; DOI: 10.5731/pdajpst.2018.009316
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