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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Bibliographische Detailangaben
Veröffentlicht in:MAbs
Hauptverfasser: Kim, Seokkyun, Song, Jinsu, Park, Seungkyu, Ham, Sunyoung, Paek, Kyungyeol, Kang, Minjung, Chae, Yunjung, Seo, Heewon, Kim, Hyung-Chan, Flores, Michael
Format: Artigo
Sprache:Inglês
Veröffentlicht: Taylor & Francis 2017
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Reports
Online Zugang: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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