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Manufacturing Methods for Producing Anti-IL12/IL23 Antibody Compositions

a technology of anti-il12/il23 and composition, which is applied in the direction of immunoglobulins, peptides, skin, etc., can solve the problems of affecting the diagnosis of subjects for several years, and affecting the quality of anti-il12/il23 antibodies

Pending Publication Date: 2020-09-17
JANSSEN BIOTECH INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides a composition of anti-IL-12 / IL-23p40 Antibodies with a specific oligosaccharide profile that results in improved effects on IL-12 and IL-23 inhibition. The oligosaccharide profile includes a high percentage of neutral species and a low percentage of charged species. The peak area of the cIEF electropherogram is greater than 70.0%. The anti-IL-12 / IL-23p40 Antibodies do not contain any disialylated glycan species, which is a unique characteristic. Compared to antibodies expressed in Sp2 / 0 cells, the anti-IL-12 / IL-23p40 Antibodies have a longer half-life. These antibodies can be used as a follow-on biologic to ustekinumab.

Problems solved by technology

In SLE, the immune system attacks the body's cells and tissue, resulting in inflammation and tissue damage which can harm the heart, joints, skin, lungs, blood vessels, liver, kidneys and nervous system.
About half of the subjects diagnosed with SLE present with organ-threatening disease, but it can take several years to diagnose subjects who do not present with organ involvement.
Existing therapies for SLE are generally either cytotoxic or immunomodulatory and may have notable safety risks.
Thus, there is a large unmet need for new alternative treatments that can provide significant benefit in this disease without incurring a high safety risk.

Method used

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  • Manufacturing Methods for Producing Anti-IL12/IL23 Antibody Compositions
  • Manufacturing Methods for Producing Anti-IL12/IL23 Antibody Compositions
  • Manufacturing Methods for Producing Anti-IL12/IL23 Antibody Compositions

Examples

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Embodiment Construction

-23 antibody,”“anti-IL-12 / 23p40 antibody,”“anti-IL-12 / IL-23p40 antibody,”“IL-12 / 23p40 antibody,”“IL-12 / IL-23p40 antibody,”““antibody portion,” or “antibody fragment” and / or “antibody variant” and the like include any protein or peptide containing molecule that comprises at least a portion of an immunoglobulin molecule, such as but not limited to, at least one complementarity determining region (CDR) of a heavy or light chain or a ligand binding portion thereof, a heavy chain or light chain variable region, a heavy chain or light chain constant region, a framework region, or any portion thereof, or at least one portion of an IL-12 and / or IL-23 receptor or binding protein, which can be incorporated into an antibody of the present invention. Such antibody optionally further affects a specific ligand, such as but not limited to, where such antibody modulates, decreases, increases, antagonizes, agonizes, mitigates, alleviates, blocks, inhibits, abrogates and / or interferes with at least o...

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Abstract

Methods of manufacture for producing anti-IL-12 / IL-23p40 antibodies, e.g., the anti-IL-12 / IL-23p40 antibody ustekinumab, in CHO and specific pharmaceutical compositions of the antibody are useful in treating various diseases.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims priority to U.S. Provisional Application No. 62 / 818,359, filed Mar. 14, 2019, the entire contents of which are incorporated herein by reference.REFERENCE TO SEQUENCE LISTING SUBMITTED ELECTRONICALLY[0002]This application contains a sequence listing, which is submitted electronically via EFS-Web as an ASCII formatted sequence listing with a file name “JBI6056USNP1SEQLIST.txt” creation date of Mar. 5, 2020 and having a size of 14,000 bytes. The sequence listing submitted via EFS-Web is part of the specification and is herein incorporated by reference in its entirety.FIELD OF THE INVENTION[0003]The present invention relates to methods of manufacture for producing anti-IL-12 / IL-23p40 antibodies, e.g., the anti-IL-12 / IL-23p40 antibody ustekinumab, and specific pharmaceutical compositions of the antibody.BACKGROUND OF THE INVENTION[0004]Interleukin (IL)-12 is a secreted heterodimeric cytokine comprised of 2 disulfide-lin...

Claims

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Application Information

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IPC IPC(8): C07K16/24C07K1/18
CPCC07K2317/14C07K16/244C12N5/0682C07K1/18C07K2317/31C07K2317/21C07K2317/41C07K2317/565C07K2317/56C07K2317/22
Inventor BARNTHOUSE, KRISTOPHERGANGULY, SUBINAYGROENEVELD, MAARTENLOPEZ, MANUELNEDVED, MICHAELSMITH, KEVIN D.
Owner JANSSEN BIOTECH INC
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