FORMULATION FOR ANTI-ALPHA4BETA7 ANTIBODY
Antibody formulations are described comprising a mixture of a non-reducing sugar, an anti-α4β7 antibody and at least one amino acid. The disclosed formulations have improved stability, reduced aggregate formation, and may retard degradation of the anti-α4β7 antibody therein or exhibit any combinations thereof The prese invention further provides a safe dosing r men of these antibody formulations that is easy to follow, and which results in a therapeutically effective amount of the anti-α4β7 antibody in vivo.
1 . A stable formulation comprising a mixture of a non-reducing sugar, an anti-α4β7 antibody and at least one free amino acid, wherein the formulation is in solid form, and the molar ratio of non-reducing sugar to anti-α4β7 antibody (mole:mole) is greater than 600:1.
2 . The formulation of claim 1 , wherein said formulation further comprises a buffering agent.
3 . The formulation of claim 1 , wherein said non-reducing sugar is selected from the group consisting of mannitol, sorbitol, sucrose, trehalose and combinations thereof.
4 . The formulation of claim 1 , wherein said free amino acid is selected from the group consisting of histidine, alanine, arginine, glycine, glutamic acid and combinations thereof.
5 .The formulation of claim 1 , wherein said formulation further comprises a surfactant.
6 . (canceled)
7 . The formulation of claim 1 , wherein said formulation is lyophilized and comprises at least about 5% to about 10% anti-α4β7 antibody before lyophilization.
8 .- 28 . (canceled)
29 . A stable formulation comprising a mixture of a non-reducing sugar, an anti-α4β7 antibody, histidine, arginine, and polysorbate 80, wherein the formulation is in solid form, and the molar ratio of non-reducing sugar to anti-α4β7 antibody (mole:mole) is greater than 600:1.
30 .- 31 . (canceled)
32 . The formulation of claim 1 , wherein said antibody is vedolizumab.
33 . A method of making the formulation of any one of claim 1 , said method comprising maintaining the product temperature below the collapse temperature during primary drying.
34 . The method of claim 33 , further comprising an annealing step.
35 . The method of claim 33 , further comprising determining the quality of the dried formulation, comprising inspecting the formulation for appearance; determining reconstitution time; determining moisture content; determining percentage of aggregates present; determining percentage of fragments present; and determining oxidation/deamidation levels.
36 .- 66 . (canceled)
67 . The formulation of claim 1 , wherein the free amino acid to antibody molar ratio is at least 250:1.
68 . (canceled)