Drifts in ADCC-related quality attributes of Herceptin®: Impact on development of a trastuzumab biosimilar

A biosimilar product needs to demonstrate biosimilarity to the originator reference product, and the quality profile of the latter should be monitored throughout the period of the biosimilar's development to match the quality attributes of the 2 products that relate to efficacy and safety. For...

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Publicado no:MAbs
Main Authors: Kim, Seokkyun, Song, Jinsu, Park, Seungkyu, Ham, Sunyoung, Paek, Kyungyeol, Kang, Minjung, Chae, Yunjung, Seo, Heewon, Kim, Hyung-Chan, Flores, Michael
Formato: Artigo
Idioma:Inglês
Publicado em: Taylor & Francis 2017
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Reports
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC5419076/
https://ncbi.nlm.nih.gov/pubmed/28296619
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1080/19420862.2017.1305530
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