A kind of injection preparation of anti-PD-L1 monoclonal antibody
A monoclonal antibody, PD-L1 technology, applied in the field of biomedicine, can solve the problems of safety and effectiveness, protein stability changes, easy formation of precipitated particles or aggregates, difficulty in obtaining stable protein preparations, etc., to achieve good biological biological activity, maintain physical stability, and ensure normal proliferation
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Embodiment 1
[0047] An injection preparation of an anti-PD-L1 monoclonal antibody provided in Example 1 of the present invention, the injection preparation includes the following ingredients:
[0048] a) anti-PD-L1 monoclonal antibody with a protein content of 10-60 mg / ml;
[0049] b) a buffer with a concentration of 10-60 mM;
[0050] c) a stabilizer at a concentration of 100-150 mM;
[0051] d) an osmotic pressure regulator at a concentration of 10-100 mM;
[0052] e) 0.005%-0.05% (w / v) surfactant;
[0053] Wherein, the pH value of the injection preparation is 5.8-6.3.
[0054] Wherein, the buffering agent includes citrate buffer, histidine hydrochloride buffer or succinate buffer; the stabilizer includes one or more of sucrose, trehalose, mannitol, glycine, methionine, arginine a mixture; the osmotic pressure regulator includes one or more mixtures of sodium chloride, magnesium chloride, glucose, sorbitol, and sodium citrate; the surfactant includes polysorbate 20, polysorbate 80, T...
Embodiment 2
[0081] Embodiment 2 of the present invention provides an injection preparation of anti-PD-L1 monoclonal antibody, which further limits the protein content of anti-PD-L1 monoclonal antibody to 18-30 mg / ml on the basis of Embodiment 1.
Embodiment 3
[0083] Embodiment 3 of the present invention provides an injection preparation of anti-PD-L1 monoclonal antibody, and the injection preparation further defines that the buffer is histidine hydrochloride buffer on the basis of Embodiment 1.
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