Acceptable changes in quality attributes of glycosylated biopharmaceuticals

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Figure 1: Comparison of the pre- and post-change Aranesp batches measured by capillary zone electrophoresis.
Figure 2: Comparison of the different pre- and post-change batches of Rituxan/Mabthera.
Figure 3: Comparison of the different pre- and post-change batches of Enbrel.

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Acknowledgements

NK3.3 cell line was generated by J. Kornbluth, St. Louis University School of Medicine, and the cell line was obtained by Novartis from St. Louis University, St. Louis. We would like to thank J. Windisch, M. McCamish, C. Sonderegger, M. Lang-Salchner and A. Seidl from Sandoz Biopharmaceuticals for their thorough review and support.

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Competing interests

The authors are employees of Novartis/Sandoz, which is developing, manufacturing and marketing biopharmaceuticals, including biosimilar products.

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Supplementary Figures 1—3, Supplementary Tables 1,2 and Supplementary Methods (PDF 439 kb)

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Schiestl, M., Stangler, T., Torella, C. et al. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotechnol 29, 310–312 (2011) doi:10.1038/nbt.1839

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