A high-concentration monoclonal antibody formulation and uses thereof
AssigneeJiangsu Biojetay Biotechnology Co., Ltd.
InventorsQinglei LI, Chuan LIAO
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Abstract
Provided is a high-concentration antibody formulation. The antibody formulation includes a monoclonal antibody and surfactants. The surfactants are polysorbate and poloxamer. The concentration of the monoclonal antibody is 100 mg/mL to 200 mg/mL. The high-concentration antibody formulation is high in stability under freeze thawing, oscillation, acceleration and long-term conditions, such that the high-concentration antibody formulation can keep good stability in the preparation, transportation and storage processes, thereby guaranteeing the clinical medication safety and quality controllability.
Claims20
A high-concentration antibody formulation, wherein the antibody formulation comprises a monoclonal antibody and surfactants, wherein the surfactants are polysorbate and poloxamer, and the concentration of the monoclonal antibody is from 100 mg/ml to 200 mg/ml, optionally from 135 mg/ml to 165 mg/ml.
Dependencies are inferred from the claim text.