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    • 3. 发明申请
    • SELECTIVE REDUCTION OF CYSTEINE RESIDUES IN IL-17 ANTIBODIES
    • 选择性还原IL-17抗体中的CYSTEINE残留
    • WO2016103146A1
    • 2016-06-30
    • PCT/IB2015/059824
    • 2015-12-21
    • NOVARTIS AGHEITZMANN, MarkusWINKLER, Johann
    • HEITZMANN, MarkusWINKLER, Johann
    • C07K16/24A61K39/395
    • C07K16/244C07K2317/14C07K2317/21C07K2317/24C07K2317/40C07K2317/565C07K2317/76
    • The present disclosure relates to methods for selectively reducing CysL97 in a preparation of IL- 17 antibodies or antigen binding fragments thereof (e.g., a preparation of secukinumab antibodies) that have been recombinantly produced by mammalian cells. Also provided are purified preparations of IL-17 antibodies or antigen binding fragments thereof produced by such methods, e.g, purified preparations of secukinumab, wherein the level of intact IL-17 antibodies or antigen binding fragments thereof (e.g., secukinumab) in the preparation is high, e.g., at least about 90%, as measured by sodium dodecyl sulfate capillary electrophoresis (CE-SDS), and wherein the level of activity of IL-17 antibodies or antigen binding fragments thereof (e.g., secukinumab) in the preparation is high, e.g., at least about 92%, as measured by cation exchange chromatograph (CEX).
    • 本公开涉及在哺乳动物细胞重组产生的IL-17抗体或其抗原结合片段(例如,secukinumab抗体的制剂)的制备物中选择性还原CysL97的方法。 还提供了通过这些方法产生的IL-17抗体或其抗原结合片段的纯化制剂,例如,secukinumab的纯化制剂,其中制剂中完整的IL-17抗体或其抗原结合片段(例如,secukinumab)的水平为 例如至少约90%,如通过十二烷基硫酸钠毛细管电泳(CE-SDS)测量的,并且其中制剂中IL-17抗体或其抗原结合片段(例如,secukinumab)的活性水平高 ,例如,通过阳离子交换色谱仪(CEX)测量的至少约92%。