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| 关于生物制品残余DNA质量控制问题 | |
| 引用本文： | 王兰,王军志. 关于生物制品残余DNA质量控制问题[J]. 中国新药杂志, 2011, 0(8) |
| 作者姓名： | 王兰 王军志 |
| 作者单位： | 中国食品药品检定研究院重组技术产品室; |
| 基金项目： | 国家“重大新药创制”科技重大专项(2009ZX09307-001); 国家高技术研究发展计划(863计划)(2007AA021601,2007AA021204) |
| 摘 要： | 随着生物医药技术的飞速发展,越来越多的哺乳动物细胞,尤其是连续传代细胞系用于生产疫苗和治疗性生物制品。重组蛋白制品的用量随着临床治疗效果的需求越来越大,由微克级上升到了毫克甚至克级,需要长期反复用药的生物制品也越来越多。同时疫苗的使用者为健康人群,而且很多疫苗使用人群也扩大到婴幼儿,这使得药品监管部门不得不更加重视疫苗等生物制品的安全性,其中细胞残余DNA的质量控制一直是人们关注的热点。本文就不同时期国内外对于DNA残留问题的看法、DNA残留量质控标准的制定、DNA残留量检测方法等研究进展作一综述,并提出残余DNA问题未来需要进一步开展的工作。 |
| 关 键 词： | 生物制品 DNA残留 质量控制 |
Issues on quality control of residual DNA in biological products |
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| WANG Lan,WANG Jun-zhi. Issues on quality control of residual DNA in biological products[J]. Chinese Journal of New Drugs, 2011, 0(8) | |
| Authors: | WANG Lan WANG Jun-zhi |
| Affiliation: | WANG Lan,WANG Jun-zhi(Division of Biopharmaceuticals,National Institutes for Food and Drug Control,Beijing 100050,China) |
| Abstract: | More and more mammalian cells,especially continuous cell lines(CCLs),were used to produce vaccines and therapeutic biological products with the rapid development of biomedical technologies.The doses of recombinant protein products has increased from microgram to milligram or even gram for the demand of clinical treatment,and more biological products needed long-term and repeated administration.Meanwhile,the users of vaccines were healthy people and many vaccines have been used for infants and youth,therefor... |
| Keywords: | biological products residual DNA quality control |
| 本文献已被 CNKI 等数据库收录！ | |