Protein formulation
AssigneeMedImmune, LLC
InventorsMonika S. Sharma, Sr., Ambarish Shah, Scott Hammond
Life of this patent
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Abstract
The present invention provides stable lyophilized formulations of bispecific antibodies or fragments thereof.
Claims22
A liquid pharmaceutical formulation comprising between about 25 μg/ml and about 250 μg/ml of a single chain bispecific antibody comprising a first and a second binding domain, wherein the first binding domain specifically binds CD3 T cell surface antigen;
- and
- wherein the formulation comprises between about 5 mM and about 125 mM citrate, between about 100 mM and about 300 mM lysine, between about 10% and about 20% trehalose, and between about 0.01% and about 1% Polysorbate 80, and has a pH of between 5.0 and about 8.0.
A lyophilized pharmaceutical formulation comprising between about 25 μg/ml and about 250 μg/ml of a single chain bispecific antibody comprising a first and a second binding domain, wherein the first binding domain specifically binds CD3 T cell surface antigen;
- and
- wherein the formulation comprises between about 5 mM and about 125 mM citrate, between about 100 mM and about 300 mM lysine, between about 0.01% and about 1% Polysorbate 80, and has a pH of between 5.0 and about 8.0.
A liquid reconstituted pharmaceutical formulation comprising between about 25 μg/ml and about 250 μg/ml of a single chain bispecific antibody comprising a first and a second binding domain, wherein the first binding domain specifically binds CD3 T cell surface antigen;
- and
- wherein the formulation comprises between about 5 mM and about 125 mM citrate, between about 100 mM and about 300 mM lysine, between about 10% and about 20% trehalose, and between about 0.01% and about 1% Polysorbate 80, and has a pH of between 5.0 and about 8.0.
Dependencies are inferred from the claim text.