PHARMACEUTICAL FORMULATION FOR ANTI-CCR8 ANTIBODIES
Patent Information
- Application Number
- ARP20250100568
- Authority / Receiving Office
- AR · AR
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-03-06
- Filing Date
- 2025-02-28
- Publication Date
- 2026-09-02
Claims
The present invention relates to safe pharmaceutical formulations for stabilizing a therapeutic anti-CCR8 antibody. The pharmaceutical formulation is provided as a liquid, such as a frozen liquid, or in lyophilized form, and may be ready to use or may be further diluted for intravenous or subcutaneous administration.
1. A pharmaceutical formulation comprising a human anti-CCR8 antibody or its antigen-binding fragment having ADCC and / or ADCP activity, wherein the pharmaceutical formulation comprises: a. 2.5-15 mM histidine; b. 50-100 ppm polysorbate, preferably polysorbate 80; c. 5%-8% sucrose; d. 10-50 mM arginine; e. 2.5-50 mM methionine; and f. 25 mg / mL-150 mg / mL of human anti-CCR8 IgG antibody, and wherein the pharmaceutical formulation is characterized by a pH of 6.3 ± 0.5.