Injection preparation of anti-PD-L1 monoclonal antibody
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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
Active Publication Date: 2020-04-10
BEIJING DONGFANG BIOTECH
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[0006] Anti-PD-L1 monoclonal antibody is a protein product for parenteral administration, including intravenous, intramuscular or subcutaneous injection, etc. It is easy to degrade in solution state, has poor physical stability, and is easy to form precipitated particles or Condensate, it is difficult to obtain stable protein preparations, and changes in the safety and effectiveness of monoclonal antibody drugs are often caused by changes in protein stability, which is also the main difficulty in the current anti-PD-L1 monoclonal antibody preparation process
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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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Abstract
The invention relates to the field of biological medicine, and particularly provides an injection preparation of an anti-PD-L1 monoclonal antibody, which comprises the anti-PD-L1 monoclonal antibody with the protein content of 10-60 mg/ml; a buffer agent having a concentration of 10-60 mM; a stabilizer with the concentration of 100 to 150 mM; an osmotic pressure regulator with the concentration of10-100 mM; and 0.005%-0.05% (w/v) of a surfactant; wherein a pH value of the injection preparation is 5.8 to 6.3. The anti-PD-L1 monoclonal antibody disclosed by the invention has relatively high affinity and good biological activity; meanwhile, different auxiliary materials are selected according to the characteristics of the anti-PD-L1 monoclonal antibody, so that the safety and effectiveness of the monoclonal antibody in the preservation process can be guaranteed, and the physical stability, chemical stability and biological stability of the anti-PD-L1 monoclonal antibody can be maintained.
Description
technical field [0001] The invention relates to the technical field of biomedicine, in particular to an injection preparation of anti-PD-L1 monoclonal antibody. Background technique [0002] With the acceleration of aging, cancer caused by environmental pollution and other factors has become the number one killer of human health. On average, 1 out of every 6 deaths in the world is caused by cancer. In the past ten years, the morbidity and mortality of malignant tumors in my country have maintained a natural growth rate of about 4% and 2.5% per year. According to the global cancer burden estimation results, the new cases and deaths of malignant tumors in my country accounted for 23.7% and 30.2% of the global new cases and deaths of malignant tumors, respectively. At present, the incidence of cancer in China is on the same level as the world average, but the prognosis of cancer in my country is relatively poor. Therefore, it is necessary to increase the awareness of cancer pr...
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