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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