JP-2022531387-A5 -

Dates

Publication Date

20230512

Application Date

20200501

Description

In certain embodiments, the pharmaceutical composition is administered intravenously. In certain embodiments, for example, the following items are provided: (Item 1) A pharmaceutical composition comprising (i) a CD80 extracellular domain (ECD)-fragment crystallizable (Fc) fusion molecule, (ii) histidine, and (iii) a sugar selected from the group consisting of sucrose and sorbitol, wherein the pH of the composition is about 5 to about 7.5. (Item 2) A pharmaceutical composition comprising a CD80 ECD-Fc fusion molecule, wherein the composition contains less than 10% of a high molecular weight species (HMWS) fusion molecule after 4 weeks at 40°C. (Item 3) A pharmaceutical composition comprising a CD80 ECD-Fc fusion molecule, wherein the composition contains approximately 1% to approximately 10% of the HMWS fusion molecule after 4 weeks at 40°C. (Item 4) A pharmaceutical composition comprising a CD80 ECD-Fc fusion molecule, wherein the composition contains less than 2.5% of a low molecular weight species (LMWS) CD80 ECD-Fc fusion molecule after 4 weeks at 40°C. (Item 5) A pharmaceutical composition comprising a CD80 ECD-Fc fusion molecule, wherein the composition contains approximately 0.5% to approximately 2.5% of the LMWS CD80 ECD-Fc fusion molecule after 4 weeks at 40°C. (Item 6) The composition according to any one of items 1 to 5, wherein the composition contains an HMWS fusion molecule in an amount of about 1% to about 6% after 4 weeks at 40°C. (Item 7) The composition according to item 6, wherein the composition contains approximately 1% to approximately 4% of HMWS fusion molecules after 4 weeks at 40°C. (Item 8) The composition according to any one of items 1 to 7, wherein the composition contains, at 40°C for 4 weeks, approximately 0.5% to approximately 1.6% of the CD80 ECD-Fc fusion molecule of LMWS. (Item 9) The composition according to item 8, wherein the composition contains approximately 0.5% to approximately 1.5% of the LMWS CD80 ECD-Fc fusion molecule after 4 weeks at 40°C. (Item 10) The composition according to any one of items 2 to 9, wherein the pH of the composition is about 5 to about 7.5. (Item 11) The composition according to any one of items 2 to 10, wherein the composition comprises histidine, optionally wherein the histidine is L-histidine. (Item 12) The composition according to any one of items 2 to 11, wherein the composition further comprises a sugar selected from the group consisting of sucrose and sorbitol. (Item 13) The composition according to any one of items 1, 11, and 13, wherein the concentration of histidine is about 15 to about 25 mM. (Item 14) The composition according to item 13, wherein the concentration of histidine is about 18 mM to about 22 mM. (Item 15) The composition according to item 14, wherein the concentration of histidine is approximately 20 mM. (Item 16) The composition according to any one of items 1 and 12 to 15, wherein the concentration of the sugar is approximately 225 mM to approximately 300 mM. (Item 17) The composition according to item 16, wherein the concentration of the sugar is approximately 250 mM to approximately 290 mM. (Item 18) The composition according to item 17, wherein the concentration of the sugar is approximately 270 mM. (Item 19) The composition according to any one of items 1 and 12 to 18, wherein the concentration of the sugar is approximately 10 to approximately 15 times the concentration of the histidine, or optionally, the concentration of the sugar is approximately 13.5 times the concentration of the buffering agent. (Item 20) The composition according to any one of items 1 to 19, further comprising a surfactant. (Item 21) The composition according to item 20, wherein the surfactant is a polysorbate, and optionally the polysorbate is polysorbate 20. (Item 22) The composition according to item 20 or 21, wherein the concentration of the surfactant is about 0.025% to about 0.075% by weight/volume (w/v). (Item 23) The composition according to item 22, wherein the concentration of the surfactant is about 0.035% to about 0.065% by weight/volume (w/v). (Item 24) The composition according to item 23, wherein the concentration of the surfactant is approximately 0.05% by weight/volume (w/v). (Item 25) The composition according to any one of items 1 to 24, wherein the concentration of the CD80 ECD-Fc fusion molecule is approximately 5 mg/ml to approximately 15 mg/ml. (Item 26) The composition according to item 25, wherein the concentration of the CD80 ECD-Fc fusion molecule is approximately 10 mg/ml. (Item 27) The composition according to any one of items 1 to 26, wherein the pH of the composition is about 5.5 to about 7.0. (Item 28) The composition according to any one of items 1 to 27, wherein the pH of the composition is about 6.4 to about 7.0. (Item 29) The composition according to any one of items 1 to 28, wherein the pH of the composition is approximately 6.7. (Item 30) The composition according to any one of items 1 to 29, wherein t