DRUG FOR B-SPECIFIC T-CELL ACTIVATORS (BITE)

摘要

1. A liquid pharmaceutical composition comprising a polypeptide, TRIS and phosphate, where the polypeptide contains the amino acid sequence shown in SEQ ID NO: 8, characterized in that the composition contains a polypeptide in a concentration of from 0.5 to 3.0 mg / ml, 100 mm TRIS and 50 mM phosphate, the pH of the composition is approximately 6.0 and 0.04% polysorbate 80.2. A composition according to claim 1, characterized in that the composition further comprises a lyoprotectant. 3. The composition according to claim 2, characterized in that the composition contains 2-10% lyoprotectant. A composition according to claim 2 or 3, characterized in that the lyoprotector is trehalose or trehalose dihydrate. 5. A composition according to claim 1, characterized in that the composition further comprises approximately 4% trehalose dihydrate. The composition according to p. 1, 2, 3 or 5, characterized in that the composition contains a polypeptide at a concentration of 2 mg / ml. A solid mixture obtained by lyophilization of a liquid composition according to any one of the preceding paragraphs. 8. A liquid pharmaceutical composition, characterized in that the composition is reconstituted by dissolving the lyophilized solid mixture of claim 7 in a suitable liquid medium. The composition according to p. 1, 2, 3, 5 or 8, characterized in that the bioavailability of the polypeptide after subcutaneous administration of the composition is 60% .10. The composition according to p. 1, 2, 3, 5 or 8 for use in a therapeutic method. 11. The composition according to p. 1, 2, 3, 5, or 8 for use in a therapeutic method, said method comprising parenteral administration of the composition. The composition according to p. 1, 2, 3, 5 or 8 for use in a method for the therapeutic treatment of hyperproliferative diseases of the prostate gland. The composition according to p. 1, 2, 3, 5 or 8 for use in a method for the therapeutic treatment of hyperproliferative diseases of the prostate gland,