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Friday, 04/22/2016 10:04:13 AM

Friday, April 22, 2016 10:04:13 AM

Post# of 20689
Pre grant patent application,

SIALYLATED GLYCOPROTEINS

"

[0101] In some embodiments, methods described herein are useful for controlling the sialylation of a reference polypeptide (e.g., a reference glycoprotein). In some embodiments, polypeptide (e.g., glycoprotein) preparations described herein have predetermined or target levels of glycans (e.g., branched glycans having a sialic acid on an .alpha.1,3 arm, and/or branched glycans having a sialic acid on an .alpha.1,6 arm, and/or branched glycans having a sialic acid on an .alpha.1,3 arm and on an .alpha.1,6 arm), where the predetermined levels are substantially similar to or different from (e.g., higher or lower than) levels of glycans (e.g., branched glycans having a sialic acid on an .alpha.1,3 arm, and/or branched glycans having a sialic acid on an .alpha.1,6 arm, and/or branched glycans having a sialic acid on an .alpha.1,3 arm and on an .alpha.1,6 arm) in a reference polypeptide product (e.g., glycoprotein product). Nonlimiting, exemplary reference glycoprotein products can include abatacept (Orencia.RTM., Bristol-Myers Squibb), abciximab (ReoPro.RTM., Roche), adalimumab (Humira.RTM., Bristol-Myers Squibb), aflibercept (Eylea.RTM., Regeneron Pharmaceuticals), alefacept (Amevive.RTM., Astellas Pharma), alemtuzumab (Campath.RTM., Genzyme/Bayer), basiliximab (Simulect.RTM., Novartis), belatacept (Nulojix.RTM., Bristol-Myers Squibb), belimumab (Benlysta.RTM., GlaxoSmithKline), bevacizumab (Avastin.RTM., Roche), canakinumab (Ilaris.RTM., Novartis), brentuximab vedotin (Adcetris.RTM., Seattle Genetics), certolizumab (CIMZIA.RTM., UCB, Brussels, Belgium), cetuximab (Erbitux.RTM., Merck-Serono), daclizumab (Zenapax.RTM., Hoffmann-La Roche), denileukin diftitox (Ontak.RTM., Eisai), denosumab (Prolia.RTM., Amgen; Xgeva.RTM., Amgen), eculizumab (Soliris.RTM., Alexion Pharmaceuticals), efalizumab (Raptiva.RTM., Genentech), etanercept (Enbrel.RTM., Amgen-Pfizer), gemtuzumab (Mylotarg.RTM., Pfizer), golimumab (Simponi.RTM., Janssen), ibritumomab (Zevalin.RTM., Spectrum Pharmaceuticals), infliximab (Remicade.RTM., Centocor), ipilimumab (Yervoy.TM., Bristol-Myers Squibb), muromonab (Orthoclone OKT3.RTM., Janssen-Cilag), natalizumab (Tysabri.RTM., Biogen Idea, Elan), ofatumumab (Arzerra.RTM., GlaxoSmithKline), omalizumab (Xolair.RTM., Novartis), palivizumab (Synagis.RTM., Medlmmune), panitumumab (Vectibix.RTM., Amgen), ranibizumab (Lucentis.RTM., Genentech), rilonacept (Arcalyst.RTM., Regeneron Pharmaceuticals), rituximab (MabThera.RTM., Roche), tocilizumab (Actemra.RTM., Genentech; RoActemra, Hoffman-La Roche) tositumomab (Bexxar.RTM., GlaxoSmithKline), and trastuzumab (Herceptin.RTM., Roche). “


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