| abstract |
PROBLEM TO BE SOLVED: To provide a preparation of a single domain antigen-binding molecule, such as a nanobody molecule, particularly a preparation of a TNF-binding nanobody molecule. (A) a TNF-binding Nanobody molecule at a concentration of about 10 to about 250 mg / mL, preferably about 10 to about 130 mg / mL, (b) sucrose, sorbitol, or a concentration of about 5 to about 10% A lyoprotectant selected from trehalose, (c) a surfactant selected from polysorbate 80 or poloxamer 188 at a concentration of about 0.01-0.6%, preferably 0.01-0.02% And (d) a buffer selected from a histidine buffer at a concentration of about 10 to about 20 mM or a Tris buffer at a concentration of about 20 mM, such that the pH of the formulation is about 5.0 to 7.5. A formulation wherein the TNF-binding Nanobody molecule in the formulation retains at least about 70% of its binding activity after storage for at least 3 months at 4 ° C. [Selection figure] None |