Selective reduction of cysteine residues in il-17 antibodies

IL298761A1Pending Publication Date: 2026-08-01NOVARTIS AG
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Patent Information

Application Number
IL298761
Authority / Receiving Office
IL · IL
Patent Type
Applications
Current Assignee / Owner
Priority Date
2014-12-22
Filing Date
2015-12-21
Publication Date
2026-08-01
Estimated Expiration
2035-12-21

AI Technical Summary

Technical Problem

Current methods for producing IL-17 antibodies like secukinumab are challenged by the presence of a free cysteine residue, which can lead to reduced activity and stability due to unwanted oxidative modifications during mammalian cell-based manufacturing, and existing techniques for reducing cysteine residues are either costly, time-consuming, or ineffective at a commercial scale.

Method used

A method involving specific ratios of antibody to reductant and controlled oxygen transfer rates is employed to selectively reduce CysL97 in IL-17 antibodies, using reducing agents like cysteine and cysteine/cystamine under controlled conditions to maintain the stability of conserved disulfide bonds and restore antigen-binding activity.

Benefits of technology

This approach effectively increases the bioactivity and homogeneity of IL-17 antibodies by selectively reducing CysL97, resulting in high levels of intact antibody and improved processing efficiency at commercial scales.

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Abstract

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).
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