06-08-2020 дата публикации
Номер: US20200247897A1
Принадлежит:
The present invention relates to formulation of antibodies. The invention relates in particular to pharmaceutical compositions comprising an antibody molecule of the IgG1 isotype having a mutation in the Fc region that enhances clustering of IgG molecules after cell-surface antigen binding. 1. A pharmaceutical composition comprisinga. one or more antibodies which comprise an Fc region of a human immunoglobulin G (IgG) and an antigen binding region, wherein the Fc region comprises a mutation of an amino acid at a position corresponding to E430, E345 or S440 in human IgG1, wherein the numbering is according to the EU numbering system,b. a histidine buffer, andc. sodium chloride,wherein the pH of the composition is between 5.5 and 7.4.2. The pharmaceutical composition according to claim 1 , wherein the composition comprises from 5 mM to 100 mM histidine claim 1 , from 25 mM to 500 mM sodium chloride claim 1 , and/or an antibody concentration from 0.5 mg/ml to 250 mg/ml.36-. (canceled)7. The pharmaceutical composition according to claim 1 , wherein the composition does not comprise a surfactant.8. The pharmaceutical composition according to claim 1 , wherein the composition does not comprise a cryoprotectant.9. (canceled)10. The pharmaceutical composition according to claim 1 , wherein the Fc region comprises a mutation selected from the group consisting of: E430G claim 1 , E345K claim 1 , E430S claim 1 , E430F claim 1 , E430T claim 1 , E345Q claim 1 , E345R claim 1 , E345Y claim 1 , S440W and S440Y.1112-. (canceled)13. The pharmaceutical composition according to claim 10 , wherein the Fc region further comprises a mutation selected from K439E or S440K.14. The pharmaceutical composition according to claim 1 , wherein the antigen binding region binds to human DR5.1516-. (canceled)17. The pharmaceutical composition according to claim 14 , wherein the antigen binding region comprises a variable heavy chain (VH) region and a variable light chain (VL) region comprising amino ...
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