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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 September 2019, pdajpst.2018.009316; DOI: https://doi.org/10.5731/pdajpst.2018.009316
Paul Wu
1 Bayer HealthCare LLC, Berkeley, CA, United States 94710;
Taymar Hartman
2 Abbvie Biotherapeutics Inc., Redwood City, CA, United States 94063;
Louise Almond
2 Abbvie Biotherapeutics Inc., Redwood City, CA, United States 94063;
Jennitte Stevens
3 Amgen Inc, Thousand Oaks, CA United States 91320;
John Thrift
1 Bayer HealthCare LLC, Berkeley, CA, United States 94710;
Juhi OJha
1 Bayer HealthCare LLC, Berkeley, CA, United States 94710;
Christina Alves
4 Biogen Inc, Cambridge, MA, United States 02141;
David Shaw
5 Genentech Inc, South San Francisco, CA, United States 94080;
Michael W Laird
5 Genentech Inc, South San Francisco, CA, United States 94080;
Robyn Emmins
6 GSK, King of Prussia, PA, United States 19406; Stevenage, United Kingdom;
Yuan Zhu
6 GSK, King of Prussia, PA, United States 19406; Stevenage, United Kingdom;
Ren Liu
7 Merck & Co., Inc., Kenilworth, NJ, United States 07033;
Zhimei Du
7 Merck & Co., Inc., Kenilworth, NJ, United States 07033;
Rolf Koehler
8 Novartis Pharma AG, 4056 Basel, Switzerland;
Thomas Jostock
8 Novartis Pharma AG, 4056 Basel, Switzerland;
Karin Anderson
9 Pfizer Inc, Andover MA, United States 01810;
Chris Campbell
10 Takeda Pharmaceuticals, Cambridge MA, United States 02039;
Howard Clarke
11 Seattle Genetics Inc, Bothell, WA, United States 98021
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 78, Issue 2
March/April 2024
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 Sep 2019, pdajpst.2018.009316; DOI: 10.5731/pdajpst.2018.009316
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 Sep 2019, pdajpst.2018.009316; DOI: 10.5731/pdajpst.2018.009316
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