Subtypes of humanized antibody against interleukin-6 receptor

Abstract

An antibody subtype (1) which is a subtype of the humanized PM-1 antibody against interleukin-6 receptor (IL-6R) and in which one C-terminal of the heavy chain is Pro-NH2 (447), and an antibody subtype (2) which is a subtype of the humanized PM-1 antibody against interleukin-6 receptor (IL-6R) and in which both C-terminals of the heavy chain are Pro-NH2 (447), and a pharmaceutical composition comprising them.

1 - 6 . (canceled) 
     
     
         7 . An antibody subtype 1 against interleukin-6 receptor (IL-6R) obtained by a process comprising the steps of:
 a) culturing CHO cells comprising at least one nucleic acid encoding for a heavy chain and at least one nucleic acid encoding for a light chain of a humanized PM-1 antibody, said culturing in a medium supplemented with a protein hydrolysate for expression of said humanized PM-1 antibody; and   b) isolating said antibody subtype 1 expressed by said CHO cells,   wherein said antibody subtype 1 comprises a heavy chain that has amino acids 1-448 of the amino acid sequence set forth in SEQ ID NO: 1, a heavy chain that has amino acids 1-447 of the amino acid sequence set forth in SEQ ID NO: 1 and a C-terminal that is Pro-NH 2 , and a light chain that has the amino acid sequence set forth in SEQ ID NO: 2.   
     
     
         8 . An antibody subtype against interleukin-6 receptor (IL-6R) obtained by a process comprising the steps of:
 a) culturing CHO cells comprising at least one nucleic acid encoding for a heavy chain and at least one nucleic acid encoding for a light chain of a humanized PM-1 antibody, said culturing in a medium supplemented with a protein hydrolysate for expression of said humanized PM-1 antibody; and   b) isolating said antibody subtype expressed by said CHO cells,   wherein said antibody subtype comprises a heavy chain that has amino acids 1-448 of the amino acid sequence set forth in SEQ ID NO: 1 in which an N-terminal glutamine (Gln) is pyroglutamylated, a heavy chain that has amino acids 1-447 of the amino acid sequence set forth in SEQ ID NO: 1 in which an N-terminal glutamine (Gln) is pyroglutamylated and a C-terminal that is Pro-NH 2 , and a light chain that has the amino acid sequence set forth in SEQ ID NO: 2.   
     
     
         9 . An antibody subtype 2 against interleukin-6 receptor (IL-6R) obtained by a process comprising the steps of:
 a) culturing CHO cells comprising at least one nucleic acid encoding for a heavy chain and at least one nucleic acid encoding for a light chain of a humanized PM-1 antibody, said culturing in a medium supplemented with a protein hydrolysate for expression of said humanized PM-1 antibody; and   b) isolating said antibody subtype 2 expressed by said CHO cells,   wherein said antibody subtype 2 comprises two heavy chains that have amino acids 1-447 of the amino acid sequence set forth in SEQ ID NO: 1 and a C-terminal that is Pro-NH 2 , and a light chain that has the amino acid sequence set forth in SEQ ID NO: 2.   
     
     
         10 . An antibody subtype against interleukin-6 receptor (IL-6R) obtained by a process comprising the steps of:
 a) culturing CHO cells comprising at least one nucleic acid encoding for a heavy chain and at least one nucleic acid encoding for a light chain of a humanized PM-1 antibody, said culturing in a medium supplemented with a protein hydrolysate for expression of said humanized PM-1 antibody; and   b) isolating said antibody subtype expressed by said CHO cells,   wherein said antibody subtype comprises two heavy chains that have amino acids 1-447 of the amino acid sequence set forth in SEQ ID NO: 1 in which an N-terminal glutamine (Gln) is pyroglutamylated and a C-terminal that is Pro-NH 2 , and a light chain that has the amino acid sequence set forth in SEQ ID NO: 2.   
     
     
         11 . An antibody subtype according to  claim 7 , wherein said medium is a serum free medium. 
     
     
         12 . An antibody subtype according to  claim 7 , wherein said protein hydrolysate is derived from beef, pork, soy beans, rice, vegetables or fish meat. 
     
     
         13 . An antibody subtype according to  claim 7 , wherein said protein hydrolysate is a fish meat-derived protein hydrolysate. 
     
     
         14 . An antibody subtype according to  claim 7 , wherein said protein hydrolysate is a vegetable-derived protein hydrolysate. 
     
     
         15 . A pharmaceutical composition comprising the antibody subtype of  claim 7 , and a pharmaceutical acceptable carrier. 
     
     
         16 . A pharmaceutical composition comprising the antibody subtype of claim  24 , and a pharmaceutical acceptable carrier. 
     
     
         17 . A pharmaceutical composition comprising the antibody subtype of  claim 9 , and a pharmaceutical acceptable carrier. 
     
     
         18 . A pharmaceutical composition comprising the antibody subtype of  claim 10 , and a pharmaceutical acceptable carrier.