| 摘要 |
<p>592644 Disclosed is a method for inhibiting or preventing cleavage of an antibody, or antigen-binding portion thereof, comprising at least a functional portion of a lambda light chain in a histidine containing formulation, the method comprising the step of inhibiting or preventing the ability of metals to cleave the antibody, or antigen-binding portion thereof. Further disclosed is a stable formulation comprising an antibody, or antigen-binding portion thereof, comprising at least a portion of a lambda light chain and a buffer system comprising histidine, wherein said formulation is substantially free of metal. Further disclosed is a stable formulation comprising an antibody, or antigen-binding portion thereof, comprising at least a portion of a lambda light chain, a buffer system comprising histidine, and a metal chelator, wherein the antibody, or antigen-binding portion thereof, is not cleaved within the hinge region or is cleaved within the hinge region at a level which is less than the level of cleavage observed in the absence of the metal chelator. Further disclosed is a stable formulation comprising a therapeutically effective amount of an antibody, or antigen-binding portion thereof, comprising a lambda light chain in a buffered solution comprising histidine with a pH of about 5 to about 7, wherein metal is present in a concentration that does not result in cleavage of the lambda light chain in the presence of histidine.</p> |
