FORMULATIONS
The present invention relates to a pharmaceutical formulation comprising (i) a therapeutically effective amount of a bispecific protein comprising a soluble T cell receptor (TCR) and an scFV; and (ii) a surfactant. The w/w ratio of surfactant to protein is in the range of 0.75:1 to 1.5:1. The formulation may further comprise a bulking agent and/or a stabiliser. A further pharmaceutical formulation comprises (i) a therapeutically effective amount of a bispecific protein comprising a soluble T cell receptor (TCR) and an scFV; (ii) a bulking agent; and (iii) a stabiliser. The w/w ratio of stabiliser to bulking agent may be greater than 1:1.
1 . A pharmaceutical formulation comprising:
a therapeutically effective amount of a bispecific protein comprising a soluble T cell receptor (TCR) and an scFV; and
a surfactant;
wherein the w/w ratio of surfactant to protein is in the range of 0.75:1 to 1.5:1.
2 . The formulation of claim 1 , wherein the w/w ratio of surfactant to protein is 1:1.
3 . The formulation of claim 1 , further comprising a bulking agent.
4 . The formulation of claim 1 , further comprising a stabiliser.
5 . The formulation of claim 4 , wherein the ratio of stabiliser to bulking agent is greater than 1:1.
6 . A pharmaceutical formulation comprising:
a therapeutically effective amount of a bispecific protein comprising a soluble T cell receptor (TCR) and an scFV;
a bulking agent; and
a stabiliser;
wherein the w/w ratio of stabiliser to bulking agent is greater than 1:1.
7 . The formulation of claim 6 , wherein the ratio of stabiliser to bulking agent is greater than 1.5:1.
8 . The formulation of claim 7 , wherein the ratio of stabiliser to bulking agent is in the range of from 3:1 to 7:1.
9 . The formulation of claim 6 , further comprising a surfactant.
10 . The formulation of claim 9 , wherein the surfactant is a polysorbate.
11 . The formulation of claim 10 , wherein the polysorbate is polysorbate 20.
12 . The formulation of claim 11 , wherein the bulking agent is a polyol.
13 . The formulation of claim 12 , wherein the polyol is mannitol.
14 . The formulation of claim 13 , wherein the stabiliser is a disaccharide.
15 . The formulation of claim 1 , further comprising a buffer.
16 . The formulation of claim 15 , wherein the buffer is phosphate/citrate.
17 . The formulation of claim 1 , having a pH in the range of from 6-7.
18 . The formulation of claim 1 , wherein the formulation is aqueous.
19 . The formulation of claim 1 , wherein the formulation is lyophilised.
20 . A method of making an aqueous pharmaceutical formulation comprising:
formulating (i) a therapeutically effective amount of a bispecific protein comprising a soluble T cell receptor (TCR) and an scFV and (ii) a surfactant,
wherein the w/w ratio of surfactant to protein is in the range of 0.75:1 to 1.5:1.
21 . A method of making an aqueous pharmaceutical formulation comprising:
formulating (i) a therapeutically effective amount of a bispecific protein comprising a soluble T cell receptor (TCR) and an scFV, (ii) a bulking agent and (iii) a stabiliser,
wherein the ratio of stabiliser to bulking agent is greater than 1:1.
22 .- 23 . (canceled)
24 . A method of treating cancer, comprising:
administering to a subject with cancer a therapeutically effective amount of the pharmaceutical formulation of claim 1 .
25 . The method of claim 24 , wherein the cancer is melanoma.