Stable high concentration sodium chloride formulations containing pd-1 antibody and methods of use thereof

A method of making an antibody formulation, the method comprising:

• (a) adding trehalose and sodium chloride to the antibody to achieve an antibody formulation having a concentration of trehalose no less than 50 mM and a concentration of sodium chloride no less than 25 mM, wherein the antibody comprises a heavy chain variable region (a) a HCDR1 (Heavy Chain Complementarity Determining Region 1) of SEQ ID NO:
• 1,
• (b) a HCDR2 of SEQ ID NO:2, (c) a HCDR3 of SEQ ID NO:3 and a light chain variable region that comprises:
• (d) a LCDR1 (Light Chain Complementarity Determining Region 1) of SEQ ID NO:4, (e) a LCDR2 of SEQ ID NO:5, and (f) a LCDR3 of SEQ ID NO:6;
• (b) concentrating the antibody formulation of (a) from 150-200 mg/mL;
• and
• (c) adding polysorbate 20 to the antibody formulation of (b) to obtain an antibody formulation having a concentration of polysorbate 20 of no less than 0.01 mg/mL,
• wherein the antibody formulation of (c) is in an aqueous solution and has a viscosity of no more than 30 cP at 25° C., and wherein the antibody formulation of (c) is stable upon agitation, freeze-thaw and thermal stress.