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Human erythropoietin hybrid Fc fusion protein phase change preparation and preparation method thereof
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A fusion protein, erythropoietin technology, applied in the biological field, can solve the problems of poor medication compliance, limited intravenous administration routes, damaged blood vessel walls, etc., achieve stable and controllable quality, avoid safety risks, Stable quality effect
Pending Publication Date: 2022-05-27
SHANGHAI CHEMO WANBANG BIOPHARMA
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Furthermore, considering that most of the applicable population are patients with wasting diseases (renal failure, cancer), their physical status is already extremely weak, and their medication compliance is often poor; in addition, such patients often experience severe damage to the vessel wall due to multiple injections , limited intravenous route of administration
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[0024] Human erythropoietin-HyFc fusion protein injection prescription (unit: g).
[0025]
[0026] Note: The amount of water for injection when the diluent is prepared here includes water for injection in which Poloxamer 407 is dissolved.
[0027] Preparation method: according to the above prescription, weigh Poloxamer 407, add water for injection, stir and dissolve, add diluent and mix, and refrigerate at ~4°C overnight to obtain solution I; . Dilute the human erythropoietin hybrid Fc fusion protein stock solution of the prescription amount to the total amount with solution II to obtain a semi-finished product, which is subjected to sterilization filtra...
Embodiment 2
[0030] Physical properties test of human erythropoietin-HyFc fusion protein in situ gel.
[0031] The phase transition temperature was measured using the test tube inversion method. The finished product was taken out from the refrigerator at 2 to 8°C, 5 ml was drawn into the test tube, and a thermometer was inserted into the sol. Put the test tube into a water bath (the water bath level is about 2-3 cm higher than the sol content), and slowly heat up (the temperature rise rate is controlled at about 1 °C per minute, and the measurement range is 15-60 °C). Tilt the test tube and observe the phase transition temperature when the content changes from a free-flowing sol state to a non-free-flowing gel state.
[0033] an examination prescription 1 prescription 2 prescription 3 prescription 4 prescription 5 phase transition temperature No apparent phase transition 37.1℃ ...
Embodiment 3
[0036] Forced degradation assay of human erythropoietin-HyFc fusion protein in situ gel.
[0037] Using forced degradation conditions (40°C ± 2°C), and selecting "purity" as the key quality indicator (acceptable limit: ≥95.0%), the stability of each formula product was investigated. The results are as follows.
[0038]
[0039] From the above table, it can be seen that when prescriptions 2 to 5 are placed under the forced degradation conditions for 5 days and 10 days, the protein purity is within the qualified range, and the product quality is stable; the protein purity of prescriptions 3 and 4 does not change significantly compared with 0 hours , can be used as the preferred prescription.
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Abstract
The invention belongs to the technical field of biology, and particularly relates to a human erythropoietinhybridFc fusionproteinphase change preparation and a preparation method thereof. The human erythropoietinhybridFc fusionprotein is a hybridFc fusionprotein expressed by CHO (Chinese HamsterOvary) cells by utilizing a recombinant DNA (DeoxyriboseNucleic Acid) technology, and structurally comprises human erythropoietin and a hybrid Fc fragment. The human erythropoietin hybrid Fc fusion protein preparation contains a human erythropoietin hybrid Fc fusion proteinstock solution and an in-situ gel matrix, does not contain human serum albumin and other exogenous harmful substances which may cause safety risks, and effectively avoids the safety risks of clinical medication while ensuring the long-term storage stability of the preparation. The preparation provided by the invention has special physical and chemical properties, is a liquid sol at room temperature, is convenient for industrial production, and can be converted into a semi-solid gel after subcutaneous injection administration to realize a slow release effect. According to the preparation method provided by the invention, the prepared preparation is stable in quality and is clinically used for treating anemia.
Description
technical field [0001] The invention belongs to the field of biotechnology, and in particular relates to a human erythropoietin hybrid Fc fusion protein phase-change preparation and a preparation method thereof. Background technique [0002] Natural human erythropoietin is a polypeptide hormone that regulates erythropoiesis, 90% of which is produced by the kidneys. At present, human erythropoietin is a short-acting genetically engineered recombinant human erythropoietin, which needs to be administered 2 to 3 times a week. It is widely used in renal anemia, anemia caused by tumor chemotherapy and other clinical applications. Treatment of anemia. [0003] The EPO-HyFc fusion protein involved in the present invention is a homodimer composed of two structural units each containing 411 amino acids connected by a pair of disulfide bonds, wherein the amino acid sequence of the human erythropoietin part is the same as that of the natural human erythropoietin. The protein is the sa...
Claims
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