Production of Biosimilar Ustekinumab In CHO Cells
a technology of ustekinumab and cho cell, which is applied in the field of producing ustekinumab antibody in cho cell, can solve the problems that the antibody-bound cytokines cannot bind to their cognate receptors, and cannot elicit an inflammatory response in the patient's body
Pending Publication Date: 2022-06-30
FYB 202 PROJECT GMBH
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Benefits of technology
The present invention relates to a method for producing a recombinant ustekinumab antibody drug product that meets certain criteria, such as low sialic acid content, low binding to IL-23 and IL-12, and inhibition of IL-12 and IL-23 target gene expression. The method involves culturing CHO host cells, genetically engineered to express the heavy chain and light chain of ustekinumab, in a suitable culture medium under conditions that allow the cells to express the heavy chain and light chain. The recombinant ustekinumab antibody is then purified and combined with pharmaceutically acceptable excipients to create the final drug product. The invention also includes a method for producing a recombinant ustekinumab antibody with a low sialic acid content, low binding to IL-23 and IL-12, and inhibition of IL-12 and IL-23 target gene expression. The drug product can be used to treat plaque psoriasis or psoriatic arthritis.
Problems solved by technology
The antibody-bound cytokines can no longer bind to their cognate receptors and are therefore not able to elicit an inflammatory response in a patient's body.
Method used
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[0129]The present invention is supported and illustrated by reference to the following nonlimiting examples.
1. Production of the Ustekinumab Antibody in CHO Cells
[0130]CHO-K1 cells were transfected with a first expression vector expressing the heavy chain of ustekinumab under the control of a first promoter and additionally containing a first selection marker gene and a second expression vector expressing the light chain of ustekinumab under the control of said first promoter and additionally containing a second selection marker gene. Transfected cells were selected by treatment with substances matching to the selection marker genes and single clones of the CHO-K1 cells were obtained after some rounds of subculturing. The supernatant of these single clones was then purified by protein A chromatography and then subjected to glycoform characterisation and activity assays as described below.
2. Glycoform Characterisation
[0131]The protein sample was diluted with 5 m...
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Abstract
The present invention relates to a method for producing an ustekinumab antibody in CHO cells. It further relates to the use of the produced antibody in the treatment of plaque psoriasis, psoriatic arthritis and inflammatory bowel disease.
Description
FIELD OF THE INVENTION[0001]The present invention relates to a method for producing an ustekinumab antibody in CHO cells. It further relates to the use of the produced antibody in the treatment of plaque psoriasis, psoriatic arthritis and inflammatory bowel disease.BACKGROUND OF THE INVENTION[0002]Ustekinumab which is marketed under the name Stelara® is a fully human IgG1κ antibody which binds to the common p40 subunit of the cytokines IL-12 and IL-23. The antibody-bound cytokines can no longer bind to their cognate receptors and are therefore not able to elicit an inflammatory response in a patient's body. In Europe ustekinumab has received a marketing authorization for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis as well as for the treatment of moderately to severely active Crohn's disease.[0003]Stelara® (ustekinumab) is expressed in a Sp2 / 0 murine myeloma cell line using a protein-free, chemically defined cell culture medium and purified by ...
Claims
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IPC IPC(8): C07K16/24A61K9/00A61K47/18A61K47/20A61K47/22A61K47/26
CPCC07K16/244A61K9/0019A61K47/183A61K2039/54A61K47/22A61K47/26A61K47/20A61K39/39591C07K2317/14C07K2317/21C07K2317/41C07K2317/76C07K2317/92
Inventor PIPPIG, SUSANNEBROCKMEYER, CARSTEN
Owner FYB 202 PROJECT GMBH