确定抗 D 免疫球蛋白候选标准的质量标准

E. N. Kalinina, N. S. Vildanova, E. S. Kormshchikova, A. Yovdiy, M. V. Smolnikova
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引用次数: 0

摘要

药品质量控制是技术周期不可分割的一部分,是产品上市销售的必要条件。无论是在俄罗斯还是在国外,在对制剂进行实验室检测时,都必须使用参考材料--经过认证的标准样品。目前,对于俄罗斯制药业来说,重要的是提供使用国家标准样品评估人抗 D 免疫球蛋白特异性活性的方法。如果不生产稳定的抗-D 抗体浓缩物并验证每批产品是否适合销售,就不可能生产这种产品。这就需要建立规范要求和制定监管文件。目的是确定抗 D 免疫球蛋白候选标准的质量标准。分析了血液制品质量控制、药品生物标准的制造和应用领域的国内外规范基础。获得了三个系列的抗 D 抗体冻干浓缩物,并对其特性进行了实验室实验研究。作为工作成果,批准了技术规范,包括消费者特征清单、评估方法说明和相关标准。所确定的要求可作为抗 D 免疫球蛋白候选标准在批量生产过程中进行质量控制的依据。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Determination of quality criteria for candidate standard for anti-D immunoglobulin
Quality control of medicines is an integral part of the technological cycle, obligatory for the release of products into public distribution. Both in Russia and abroad, when carrying out of laboratory testing of the preparations, it is prescribed to use the reference materials – the certified standard samples. Currently, it is important for the Russian pharmaceutical industry to provide the methods for evaluating the specific activity of human anti-D immunoglobulin with a national standard sample. Its production is impossible without the production of stabilized concentrate of anti-D antibodies and verifying the suitability of each batch for sale. This requires the establishment of specification requirements and the development of regulatory documentation.Aim is to define the quality criteria for candidate standard for anti-D immunoglobulin.Material and methods. The national and foreign normative bases in the field of quality control of blood products, manufacturing and application of biological standards of medicines were analyzed. Three series of lyophilized concentrate of anti-D antibodies were obtained and a laboratory-experimental study of their properties was carried out.Results and discussion. As a result of the work done, technical specifications were approved, including a list of consumer characteristics, a description of the methods for their assessment and relevant norms.Conclusions. The established requirements can become the basis for the releasing quality control of the candidate standard for anti-D immunoglobulin during its serial production.
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