Lyophilized formulations of engineered anti-IL-23p19 antibodies
AssigneeSchering Corporation
InventorsXuhong Li, Ramesh S. Kashi, Aniket Badkar
Life of this patent
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Abstract
The present invention provides lyophilized formulations of antibodies, such as antibodies that specifically bind to human interleukin-23 p19 (IL-23p19), or antigen binding fragments thereof.
Claims14
A lyophilized formulation of an anti-human IL-23p19 antibody, or antigen binding fragment thereof, comprising:
- a) said anti-human IL-23p19 antibody, or antigen binding fragment thereof;
- b) sodium citrate;
- c) polysorbate 80;
- and
- d) sucrose
- wherein the antibody, or antigen binding fragment thereof, comprises:
- i) a light chain comprising CDRL1, CDRL2 and CDRL3, wherein:
- CDRL1 comprises the sequence of SEQ ID NO:36;
- CDRL2 comprises the sequence of SEQ ID NO:41;
- and
- CDRL3 comprises the sequence of SEQ ID NO:46;
- and
- ii) a heavy chain comprising CDRH1, CDRH2 and CDRH3, wherein:
- CDRH1 comprises the sequence of SEQ ID NO:19;
- CDRH2 comprises a sequence selected from the group consisting of SEQ ID NOs:24-26;
- and
- CDRH3 comprises the sequence of SEQ ID NO:31.
A lyophilized pharmaceutical formulation of an anti-human IL-23p19 antibody, or antigen binding fragment thereof, made by lyophilizing an aqueous solution comprising:
- a) 5-25 mg/mL anti-human IL-23p19 antibody, or antigen binding fragment thereof;
- b) about 50 mM sucrose;
- c) about 0.05 mg/mL polysorbate 80;
- and
- d) about 2.5 mM citrate buffer at pH 4.4-5.2,
- wherein the antibody, or antigen binding fragment thereof, comprises:
- i) a light chain comprising CDRL1, CDRL2 and CDRL3, wherein:
- CDRL1 comprises the sequence of SEQ ID NO:36;
- CDRL2 comprises the sequence of SEQ ID NO:41;
- and
- CDRL3 comprises the sequence of SEQ ID NO:46;
- and
- ii) a heavy chain comprising CDRH1, CDRH2 and CDRH3, wherein:
- CDRH1 comprises the sequence of SEQ ID NO:19;
- CDRH2 comprises a sequence selected from the group consisting of SEQ ID NOs:24-26;
- and
- CDRH3 comprises the sequence of SEQ ID NO:31.
A lyophilized pharmaceutical formulation of an anti-human IL-23p19 antibody, or antigen binding fragment thereof, that when reconstituted comprises:
- a) 25-100 mg/mL anti-human IL-23p19 antibody, or antigen binding fragment thereof;
- b) about 200 mM sucrose;
- c) about 0.2 mg/mL polysorbate 80;
- and
- d) about 10 mM citrate buffer at pH 4.4 to 5.2,
- wherein the antibody, or antigen binding fragment thereof, comprises:
- i) a light chain comprising comprising CDRL1, CDRL2 and CDRL3, wherein:
- CDRL1 comprises the sequence of SEQ ID NO:36;
- CDRL2 comprises the sequence of SEQ ID NO:41;
- and
- CDRL3 comprises the sequence of SEQ ID NO:46;
- and
- ii) a heavy chain comprising CDRH1, CDRH2 and CDRH3, wherein:
- CDRH1 comprises the sequence of SEQ ID NO:19;
- CDRH2 comprises a sequence selected from the group consisting of SEQ ID NOs:24-26;
- and
- CDRH3 comprises the sequence of SEQ ID NO:31.
Dependencies are inferred from the claim text.