US2020080125A1PendingUtilityA1

Method for the production of a glycosylated immunoglobulin

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Assignee: HOFFMANN LA ROCHEPriority: Oct 26, 2009Filed: Nov 13, 2019Published: Mar 12, 2020
Est. expiryOct 26, 2029(~3.3 yrs left)· nominal 20-yr term from priority
Inventors:Reinhard FranzeChikashi HirashimaThomas Hamilton LinkYoshinori TakagiShinya TakumaYuriko Tsuda
C07K 2317/24C07K 2317/14A61K 39/395C07K 2317/41C07K 16/28C12P 21/005C07K 2317/76C07K 16/2866
72
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Claims

Abstract

Herein is reported a method for the production of an immunoglobulin comprising the following steps: a) providing a eukaryotic cell comprising a nucleic acid encoding the immunoglobulin, b) cultivating the eukaryotic cell in a cultivation medium wherein the amount of glucose available in the cultivation medium per time unit is kept constant and limited to less than 80% of the amount that could maximally be utilized by the cells in the cultivation medium per time unit, and c) recovering the immunoglobulin from the culture.

Claims

exact text as granted — not AI-modified
1 .- 22 . (canceled) 
     
     
         23 . A composition comprising an antibody protein that binds human interleukin 6 receptor (anti-IL-6R antibody) with mannose-5 glycostructure (M5) attached thereto, wherein the fraction of the anti-IL-6R antibody protein with M5 attached thereto in the composition is 6% or less of the sum comprising the anti-IL-6R antibody with M5, G(0), G(1), and G(2) oligosaccharide attached thereto. 
     
     
         24 . The composition according to  claim 23 , wherein the anti-IL-6R antibody protein is Tocilizumab protein. 
     
     
         25 . The composition according to  claim 23 , wherein the anti-IL-6R antibody protein with M5 attached thereto has been produced by a recombinant Chinese Hamster Ovary (CHO) cell. 
     
     
         26 . (canceled) 
     
     
         27 . The composition according to  claim 23 , wherein the M5 fraction is 4% or less. 
     
     
         28 . The composition according to  claim 23 , wherein the M5 is attached to Asn297 of the anti-IL-6R antibody. 
     
     
         29 . The composition according to  claim 23 , further comprising anti-IL-6R antibody protein with G(0), G(1), or G(2) oligosaccharide attached thereto. 
     
     
         30 . The composition according to  claim 23 , wherein the M5 fraction is in the range from 2.8% to 6%. 
     
     
         31 . A composition comprising Tocilizumab protein with mannose-5 glycostructure (M5) attached to Asn297 thereof, wherein the fraction of Tocilizumab with M5 attached thereto in the composition is less than 5% of the sum comprising Tocilizumab with MS, G(0), G(1), and G(2) oligosaccharide attached thereto. 
     
     
         32 . The composition according to  claim 31 , wherein the Tocilizumab protein with M5 attached thereto has been produced by a recombinant Chinese Hamster Ovary (CHO) cell. 
     
     
         33 . The composition according to  claim 31 , wherein the M5 fraction is 4% or less. 
     
     
         34 . The composition according to  claim 31 , wherein the M5 fraction is in the range from 2.8% to less than 5%. 
     
     
         35 . The composition according to  claim 31 , further comprising the Tocilizumab protein with G(0), G(1), or G(2) oligosaccharide attached to Asn 297  thereof.

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