Production of Biosimilar Ustekinumab In CHO Cells

A method of producing a recombinant ustekinumab antibody drug product comprising the heavy chain and the light chain of ustekinumab, wherein the heavy chain has the sequence according to SEQ ID No. 1 and the light chain has the sequence according to SEQ ID No. 2 and wherein the heavy chain and the light chain together form the recombinant ustekinumab antibody, the method comprising:

• a) culturing Chinese Hamster Ovary (CHO) host cells, genetically modified to express the heavy chain and the light chain of ustekinumab, in a suitable culture medium under conditions that allow the cells to express the heavy chain and the light chain and to form the recombinant ustekinumab antibody;
• b) harvesting the recombinant ustekinumab antibody from the host cell culture to obtain a recombinant ustekinumab antibody preparation;
• c) optionally purifying the recombinant ustekinumab antibody preparation obtained in step b) by one or more purification step(s);
• d) determining that the recombinant ustekinumab antibody in the recombinant ustekinumab antibody preparation obtained in step b) or c) meets one or more of the following criteria (i) to (iv):
• (i) binding to IL-23 differs from that of the reference product by not more than 10%;
• (ii) binding to IL-12 differs from that of the reference product by not more than 20%;
• (iii) binding to FcRn differs from that of the reference product by less than 10%;
• and
• (iv) inhibition of IL12- and/or IL23-induced target gene expression differs from that of the reference product by not more than 20%;
• and
• e) combining the recombinant ustekinumab antibody from the recombinant ustekinumab antibody preparation with one or more pharmaceutically acceptable excipients to obtain the recombinant ustekinumab antibody drug product.