Module 9 2024

05/09/2024

Small Differences in Glycan Profile can Impact Potency – Even Observed in Licensed Reference Product !

Rel. % ADCC Potency for batches of Reference Product

Difference in ADCC activity

Rel. % of G0 Afucosylated Glycan in

batches of Reference Product

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Small Differences in Glycan Profile can Impact Potency – Even Observed in Licensed Refence Product!

Seokkyun Kim, Jinsu Song, Seungkyu Park,

Sunyoung Ham, Kyungyeol Paek, Minjung Kang, Yunjung Chae,

Heewon Seo, Hyung Chan Kim & Michael Flores (2017): Drifts in ADCC-related quality attributes of Herceptin®: Impact on development of a trastuzumab biosimi. mAbs, DOI: 10.1080/19420862.20 17.1305530 To link to this article: http://dx.doi.org/10.1 080/19420862.2017.1 305530

The Organisation for Professionals in Regulatory Affairs

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