Comparability strategy and demonstration for post-approval production cell line change of a bevacizumab biosimilar IBI305

ABSTRACT: Abstract High-producing cell line could improve the affordability and availability of biotherapeutic products. A post-approval production cell line change, low-titer CHO-K1S to high-titer CHO-K1SV GS-KO, was performed for a China marketed bevacizumab biosimilar IBI305. Currently, there is no regulatory guideline specifically addressing the requirements for comparability study of post-approval cell line change, which is generally regarded as the most complex process change for biological products. Following the quality by design principle and risk assessment, an extensive analytical characterization and three-way comparison was performed by using a panel of advanced analytical methods. Orthogonal and state-of-the-art techniques including nuclear magnetic resonance and high-resolution mass s

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PROVIDER: S-EPMC10481892 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature