Pharmaceutical anti-tnf-alpha antibody formulation

A liquid aqueous pharmaceutical formulation, wherein the liquid aqueous pharmaceutical formulation has a pH of 5 to 5.5 and is free or substantially free of a phosphate buffer, wherein the liquid aqueous pharmaceutical formulation comprises a therapeutically effective amount of adalimumab in a buffered solution comprising L-histidine and (i) citrate and/or (ii) acetate, wherein:

• (a) the liquid aqueous pharmaceutical formulation has a content of aggregated species of adalimumab of less than about 5% after storage at 5° C. for 3 to 6 months;
• (b) the liquid aqueous pharmaceutical formulation has a content of aggregated species of adalimumab of less than about 5% after storage at 25° C. for 3 to 6 months;
• (c) the liquid aqueous pharmaceutical formulation has a content of aggregated species of adalimumab of less than about 40% after storage at 25° C. for 3 to 6 months;
• (d) the liquid aqueous pharmaceutical formulation has a content of aggregated species of adalimumab of less than about 5% under heat stress conditions at 55° C.;
• (e) the liquid aqueous pharmaceutical formulation has a content of acidic species of adalimumab of less than about 40% under heat stress conditions at 55° C.;
• (f) the liquid aqueous pharmaceutical formulation has enhanced stability of at least 6 months at a temperature of about 5° C. or 25° C.;
• or
• (g) the liquid aqueous pharmaceutical formulation retains at least about 80% TNFα neutralizing activity after storage of 6 months at a temperature of about 5° C. or 25° C. and/or after being subjected to heat stress at 55° C., freeze-thaw conditions from −20° C. to 5° C., and/or mechanical stress.