Analytical comparability study of recombinant monoclonal antibody therapeutics

Process changes are inevitable in the life cycle of recombinant monoclonal antibody therapeutics. Products made using pre- and post-change processes are required to be comparable as demonstrated by comparability studies to qualify for continuous development and commercial supply. Establishment of co...

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Detalhes bibliográficos
Publicado no:MAbs
Main Authors: Ambrogelly, Alexandre, Gozo, Stephen, Katiyar, Amit, Dellatore, Shara, Kune, Yune, Bhat, Ram, Sun, Joanne, Li, Ning, Wang, Dongdong, Nowak, Christine, Neill, Alyssa, Ponniah, Gomathinayagam, King, Cory, Mason, Bruce, Beck, Alain, Liu, Hongcheng
Formato: Artigo
Idioma:Inglês
Publicado em: Taylor & Francis 2018
Assuntos:
Review
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC5973765/
https://ncbi.nlm.nih.gov/pubmed/29513619
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1080/19420862.2018.1438797
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