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Pharmaceutical products and stable liquid compositions of il-17 antibodies

A technology for liquid compositions and drug products, which can be used in drug combinations, antibodies, drug delivery, etc., and can solve problems such as difficulties

Active Publication Date: 2017-10-17
NOVARTIS AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Balancing so many requirements is difficult, making the production of commercially viable aqueous biopharmaceutical compositions a technical challenge

Method used

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  • Pharmaceutical products and stable liquid compositions of il-17 antibodies
  • Pharmaceutical products and stable liquid compositions of il-17 antibodies
  • Pharmaceutical products and stable liquid compositions of il-17 antibodies

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0168] 1.1.1 Example 1: L-methionine

[0169] The effect of several antioxidant stabilizers on the stability of secukinumab was characterized using a large set of analytical techniques.

[0170] In earlier studies, a range of antioxidant stabilizers were evaluated, including tetrasodium EDTA, sodium ascorbate, cysteine, sodium bisulfate, and sodium citrate. Although none of these stabilizers sufficiently stabilized the molecule, tetrasodium EDTA and sodium citrate were observed on aggregated products measured by SEC compared to compositions without antioxidant stabilizers. Small stabilizing effect (data not shown).

[0171]In a further study, 10 mM concentrations of the stabilizers cysteine, tetrasodium EDTA, and L-methionine were evaluated and compared with no stabilizers using a secukinumab concentration of 150 mg / mL using the DoE method. Compositions were filled into PFS and subjected to 2-month stability studies under long-term (5°C), accelerated (25°C) and stress (40°C)...

Embodiment 2

[0183] 1.1.2 Example 2: Headspace Oxygen Content

[0184] 1.1.2.1 Primary Packaging - PFS:

[0185] The effect of headspace oxygen content on threo The influence of gold monoclonal antibody stability. Compositions were filled into 1 mL of PFS from each PFS supplier. The measured headspace oxygen content was between 13% and 15% (0.5 mL fill volume) or between 3-4% (0.5 mL fill volume) / 7-8% (1.0 mL fill volume), respectively. Store samples under long-term, accelerated and stress conditions for up to six months. Selected compositions were stored under long-term conditions for up to 24 months. Secukinumab stability was monitored by: SEC purity, RP-HPLC purity, CEX purity, CE-SDS purity (non-reducing), turbidity, color, free SH groups, biological activity, measured by photoblocking Insoluble particles and visible particles.

[0186] The effect of headspace oxygen content was observed by species and AP-SEC prior to passage through the RP-HPLC main peak under long-term, accel...

Embodiment 3

[0202] 1.1.3 Example 3: Interaction between L-methionine concentration and headspace oxygen content

[0203] Further studies evaluated the interaction between L-methionine concentration and headspace oxygen content. Compositions were prepared comprising L-methionine in the range of 2.5-7.5 mM and headspace oxygen content between 3 and 9%. Compositions were filled into PFS and stored for 6 months under long-term and accelerated conditions. The relevant secukinumab property attributes were monitored after 3 and 6 months of storage (SEC purity, RP-HPLC purity, CEX purity, free SH groups, biological activity, insoluble particulates and visible particles by light obscuration, turbidity and color of the solution). Figure 10 AP-SEC purity after 6 months storage at 25°C is shown as a function of L-methionine and headspace oxygen content. When analyzed using AP-SEC purity, no interactions were observed in the range tested.

[0204] In another study, the effect of reduced headspace...

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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).

Description

[0001] related application [0002] This application claims priority to US Provisional Patent Application No. 62 / 095210, filed December 22, 2014, which is incorporated herein by reference in its entirety. technical field [0003] The present disclosure pertains to pharmaceutical products comprising stable liquid pharmaceutical compositions of IL-17 antibodies and antigen-binding fragments thereof, such as AIN457 (secukinumab), and processes for making these pharmaceutical products and liquid pharmaceutical compositions. Background technique [0004] IL-17A is a central lymphokine of Th17 cells, a newly defined subset of inflammatory T cells, which are critical in several autoimmune and inflammatory processes. IL-17A neutralization is expected to treat the underlying pathophysiology of immune-mediated diseases, thereby providing symptomatic relief. Secukinumab (AIN457), a high-affinity fully human monoclonal anti-human antibody that inhibits IL-17A activity, has emerged as a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395A61K9/08A61K47/18A61K47/26A61K47/10A61P37/02A61P17/06A61P19/02A61P19/08A61P29/00
CPCA61K9/0019A61K9/08A61K39/39591A61K47/10A61K47/18A61K47/26C07K16/244C07K2317/21A61P17/06A61P19/02A61P19/08A61P29/00A61P37/02A61P37/06
Inventor S·乔戈K·瑟尔诺-朔尔施
Owner NOVARTIS AG
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