Pharmaceutical products and stable liquid compositions of IL-17 antibodies
AssigneeNovartis AG
InventorsSusanne Joerg, Kathrin Serno-Schersch
Life of this patent
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Abstract
The disclosure is directed to pharmaceutical products and stable liquid compositions of IL-17 antibodies and antigen-binding fragments thereof, e.g., AIN457 (secukinumab), and processes of making these pharmaceutical products and compositions. The disclosure is also directed to the use of these pharmaceutical products and liquid compositions (e.g., as part of a kit having instructions for use) for the treatment of various IL-17-mediated disorders (e.g., autoimmune disorders, such as psoriasis, ankylosing spondylitis, psoriatic arthritis, and rheumatoid arthritis).
Claims47
A process for preventing secukinumab oxidation, comprising
- a. preparing a liquid composition by combining secukinumab and methionine;
- and
- b. disposing said liquid composition in a container thereby providing a container having the liquid composition and a headspace, the liquid composition
- i. having a pH of about 5.2 to about 6.2,
- ii. comprising about 20 mg/mL to about 175 mg/mL secukinumab, and
- iii. comprising at least 2.5 mM methionine, wherein the container is adjusted to have a headspace oxygen level that is reduced relative to the oxygen level of air by introducing an inert gas into the headspace, by placing the container in a system and removing oxygen by applying a vacuum, or both.
Dependencies are inferred from the claim text.