Selective reduction of cysteine residues in il-17 antibodies
AssigneeNovartis AG
InventorsMarkus HEITZMANN, Johann WINKLER
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AssigneeNovartis AG
InventorsMarkus HEITZMANN, Johann WINKLER
Estimating the term…
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).
A composition comprising a mixture of secukinumab molecules with and without C-terminal lysine residues on the heavy chain from CHO cell production, wherein at least 90% of the secukinumab molecules are unmasked at CysL97 as measured by cystamine-CEX, and wherein the intactness of the secukinumab molecules in the composition is at least 90% as measured by non-reducing CE-SDS.
A composition comprising an enriched mixture of secukinumab molecules with and without C-terminal lysine residues on the heavy chain from CHO cell production, wherein at least 90% of the secukinumab molecules in the enriched mixture are unmasked at CysL97 as measured by cystamine-CEX.
A purified preparation of secukinumab molecules with and without C-terminal lysine residues on the heavy chain from CHO cell production, wherein at least 90% of the secukinumab molecules in the purified preparation are unmasked at CysL97 as measured by cystamine-CEX, and wherein the intactness of the secukinumab molecules in the purified preparation is at least 90% as measured by non-reducing CE-SDS.
Dependencies are inferred from the claim text.