STABLE FORMULATIONS FOR ANTI-CD19 ANTIBODIES AND ANTIBODY-DRUG CONJUGATES
This disclosure provides optimized formulations for CD19 antibodies and antibody-drug conjugates (ADCs)
1 . A stable formulation comprising an anti-CD19 antibody conjugated to monomethylauristatin F (MMAF), a phosphate buffer, a surfactant and a bulking agent,
wherein the anti-CD19 antibody comprises a light chain variable region having an amino acid sequence of SEQ ID NO:1 and a heavy chain variable region having an amino acid sequence of SEQ ID NO:2,
wherein the phosphate buffer has a pH value between 5.0 and 7.0,
wherein the surfactant is polysorbate 80 at a concentration between 0.01% and 0.05% w/v, and
wherein the bulking agent is a sugar at a concentration between 10 mg/ml and 75 mg/ml.
2 . The stable formulation of claim 1 , wherein the phosphate buffer is a sodium phosphate buffer.
3 . The stable formulation of claim 1 , wherein the phosphate buffer is a potassium phosphate buffer.
4 . The stable formulation of claim 1 , wherein the phosphate buffer has a pH between about 5.5 and about 6.5.
5 . The stable formulation of claim 1 , wherein the phosphate buffer has a pH of about 6.0.
6 .- 11 . (canceled)
12 . The stable formulation of claim 1 , wherein the polysorbate 80 is at a concentration of about 0.02% w/v.
13 - 14 . (canceled)
15 . The stable formulation of claim 14 , wherein the sugar is selected from the group consisting of sucrose and trehalose.
16 . (canceled)
17 . The stable formulation of claim 15 , wherein the sugar is sucrose.
18 . The stable formulation of claim 17 , wherein the sucrose concentration is about 60 mg/ml.
19 . A stable formulation of claim 1 , wherein the phosphate buffer is a potassium phosphate buffer at about pH 6.0.
20 . A stable lyophilized anti-CD19 antibody formulation, made by lyophilizing the formulation of claim 19 .
21 . A vial comprising the stable lyophilized anti-CD19 antibody formulation of claim 20 , in an amount for administration to a patient in need of such formulation.
22 . A stable liquid anti-CD19 antibody formulation of claim 19 .
23 . A vial comprising the stable liquid anti-CD19 antibody formulation of claim 22 , in an amount for administration to a patient in need of such formulation.
24 . The stable formulation of claim 1 , wherein the concentration of the anti-CD19 antibody conjugated to monomethylauristatin F (MMAF) is about 15 mg/ml.