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pro vyhledávání: '"Matthew Reeser"'
Autor:
Amie M. Lundquist, Duncan McVey, Zhimei Du, Jennifer Di-Carlo, Nan-Xin Qian, Matthew Reeser, Jared Spidel, Yuan Zhu, Sarah Amelia Milne, Tony Gill, Karin Anderson, John A. Follit, Michael W. Laird, Anke Mayer-Bartschmid, John Gill, Hervé Broly, Andrew J. Racher, Christian Bender, Jerry Carson, Alison Porter, Sampath R. Kumar, Qingxiang Wei, Robyn Emmins, David E. Shaw, Ankita Khatri, Frank Lee, Marilyne Failly, Ivan Carubelli, Kyle Zingaro, Christine Demaria, Christina S. Alves
Publikováno v:
PDA Journal of Pharmaceutical Science and Technology. 72:438-450
Monoclonality of mammalian cell lines used for production of biologics is a regulatory expectation and one of the attributes assessed as part of a larger process to ensure consistent quality of the biologic. Historically, monoclonality has been demon