High concentration protein formulations with reduced viscosity
The present disclosure, among other things, provides low-viscosity, high concentration therapeutic protein agent formulations.
1. An antibody agent formulation comprising:
(i) one or more antibody agents at a concentration between about 10 mg/mL and about 300 mg/mL; and
(ii) a viscosity-reducing agent that comprises a combination of nicotinic acid (acid form) and tryptophan, present at a concentration between about 5 mM and about 100 mM each, wherein:
the formulation has a viscosity between about 1 cP and about 100 cP when measured at 25° C., using a cone and plate viscometer.
2. The formulation of claim 1 , further comprising one or more buffering agents selected from the group consisting of phosphate, histidine, citrate, acetate, tris, imidazole, and combinations thereof.
3. The formulation of claim 2 , wherein the one or more buffering agents is or comprises phosphate buffer.
4. The formulation of claim 3 , wherein the one or more buffering agents are present at a concentration between about 15 mM and about 50 mM.
5. The formulation of claim 1 , wherein the formulation has a stable pH between about 4.0 and about 9.0.
6. The formulation of claim 1 , further comprising at least one additional viscosity reducing agent selected from the group consisting of caffeine citrate, caffeine nicotinate, and combinations thereof.
7. The formulation of claim 1 , wherein the formulation comprises a concentration between 50 mg/mL and about 300 mg/mL of the one or more protein agents.
8. The formulation of claim 1 , wherein the formulation has a viscosity between about 1 cP and about 50 cP when measured at 25° C., using a cone and plate viscometer.