主权项 |
1. A composition comprising (i) a conjugate comprising a humanized monoclonal antibody chemically coupled to N2′-deacetyl-N2′-(3-mercapto-1-oxopropyl)-maytansine (DM1) via a linker molecule selected from the group consisting of N-succinimidyl 4-(2-pyridyldithio)pentanoate (SPP) and N-succinimidyl-4-(N-maleimidomethyl)cyclohexane-1-carboxylate (SMCC), (ii) about 10 mM to about 20 mM of a buffering agent selected from the group consisting of an acetate buffer, a succinate buffer, and a histidine buffer, (iii) about 0.1% to about 3% wt./vol., about 2% to about 5% wt./vol., or about 4% to about 6% wt./vol. sucrose, (iv) about 50 mM to about 500 mM glycine or mannitol, (v) about 0.002% to about 0.1% wt./vol. of a surfactant, and (vi) water, wherein the composition has a pH of about 5-6. |