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首页> 外文期刊>Ukrainian Biochemical Journal >Development of the method for microbiological purity testing of recombinant human interleukin-7-based product
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Development of the method for microbiological purity testing of recombinant human interleukin-7-based product

机译:基于重组人白介素7的产品的微生物纯度测试方法的开发

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The goal of the work was justification of standardization parameters of the product based on recombinant human IL-7 by “microbiological purity” parameter and development of its measurement method with consideration of the requirements of guideline documents regarding quality of medicinal products. Suitability assessment of microbiological purity testing procedures was performed. It has been established that the studied product in standard testing methods possessed antimicrobial activity against test microorganisms Basillus subtilis ATCC 6633 (on soybean casein digest agar and Sabouraud dextrose agar containing an antibiotic), Candida albicans АТСС 10231 (on soybean casein digest agar and Sabouraud dextrose agar containing an antibiotic), and possessed no antimicrobial activity against test microorganisms Staphylococcus aureus ATCC 6538 (on soybean casein digest agar) and Pseudomonas aeruginosa ATCC 9027 (on soybean casein digest agar). The efficacy of lecithin and polysorbate as substances eliminating antibacterial effect in combination with 50-fold dilution of the test sample has been suggested and proven for the purpose of antimicrobial activity neutralization. The developed total aerobic microbial count measurement procedure for the test product conforms to acceptance criteria provided by SPU (2.6.12), and can be used for its microbiological purity control.
机译:该工作的目的是通过“微生物纯度”参数来证明基于重组人IL-7的产品标准化参数的合理性,并考虑到有关药品质量的指导性文件的要求,开发其测量方法。进行了微生物纯度测试程序的适用性评估。已经确定,在标准测试方法中研究的产品对测试微生物具有抗微生物活性,对枯草芽孢杆菌ATCC 6633(对大豆酪蛋白消化琼脂和含有抗生素的Sabouraud葡萄糖琼脂),白色念珠菌АТСС10231(对大豆酪蛋白消化琼脂和Sabouraud葡萄糖)琼脂中含有抗生素),对测试微生物没有金黄色葡萄球菌ATCC 6538(在大豆酪蛋白消化琼脂上)和铜绿假单胞菌ATCC 9027(在大豆酪蛋白消化琼脂上)具有抗菌活性。已经提出卵磷脂和聚山梨酯作为消除抗菌作用的物质与50倍稀释的测试样品相结合的功效,并已被证明可用于中和抗菌活性。为测试产品开发的总需氧微生物计数测量程序符合SPU(2.6.12)提供的验收标准,可用于其微生物纯度控制。

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