重组肠道病毒71型疫苗(汉逊酵母)抗原冻干参考品的制备及稳定性研究 |
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引用本文: | 张改梅 陈磊 赵丽丽 谢学超 李国顺 肖海峰 郭林 徐颖之 朱芮波 刘建凯 顾美荣. 重组肠道病毒71型疫苗(汉逊酵母)抗原冻干参考品的制备及稳定性研究[J]. 国际生物制品学杂志, 2020, 43(6): 267-270. DOI: 10.3760/cma.j.cn311962-20200831-00085 |
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作者姓名: | 张改梅 陈磊 赵丽丽 谢学超 李国顺 肖海峰 郭林 徐颖之 朱芮波 刘建凯 顾美荣 |
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作者单位: | 北京民海生物科技有限公司研发中心 102600
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摘 要: | 目的 制备重组肠道病毒71型(enterovirus A71,EV-A71)疫苗(汉逊酵母)抗原冻干参考品,用于重组EV-A71疫苗(汉逊酵母)的抗原含量测定。方法 选取检定合格的重组EV-A71疫苗(汉逊酵母)原液,加入冻干保护剂,冷冻干燥制备重组EV-A71疫苗(汉逊酵母)抗原冻干参考品,对其进行保护剂抗原含量标定,并对其进行反复冻融试验,37 ℃、2~8 ℃和-20 ℃稳定性研究。结果 制备的抗原冻干参考品鉴别试验、无菌检查结果均符合规定,水分含量为1.4%。经标定,几何均值为2 146 U/ml,几何变异系数为7.2%。10次反复冻融,抗原含量仍无明显变化;37 ℃放置3个月,抗原含量无明显变化;2~8 ℃和-20 ℃分别放置30个月,抗原含量仍较为稳定。 结论 制备了一批稳定的、均一性良好的抗原冻干参考品,可以用于重组EV-A71型疫苗(汉逊酵母)抗原含量测定。
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关 键 词: | 肠道病毒71型 重组疫苗 抗原 参考品 稳定性 |
The preparation of freeze-dried recombinant enterovirus A71 vaccine (Hansenula) antigen reference and its stability#br# |
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Affiliation: | Center of Research and Development, Beijing Minhai Biotechnology Co., Ltd., Beijing 102600, China
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Abstract: | Objective To prepare a lyophilized reference antigen of recombinant enterovirus 71 vaccine (Hansenula) for the determination of antigen content of recombinant EV-A71 vaccine (Hansenula). Methods Bulk of qualified recombinant EV- A71 vaccine (Hansenula) was selected as the raw material of reference, adding freeze-dried protective agent, then lyophilized to prepared freeze-dried recombinant EV-A71 (Hansenula) vaccine antigen reference, after the calibration on the antigen content, the reference was carried on the freeze-thaw test, stored at 37 ℃, 2-8 ℃ and -20 ℃ for the stability study. Results All the quality indexes of prepared reference met the relevant requirements, and the moisture content was 1.4%. After calibration, geometry mean of reference antigen content was 2 146 U/ml and geometric variation coefficient was 7.2%.There was no significant change in antigen content after repeated freezing and thawing for 10 times. There was no significant change in antigen content for 3 months at 37 ℃.The antigen content remained stable at 2-8 ℃ and -20 ℃ for 30 months, respectively. Conclusion A batch of stable and homogeneous reference antigens were prepared, which could be applied for the determination of antigen content in recombinant EV-A71 vaccine (Hansenula). |
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Keywords: | Enterovirus 71 Recombinant vaccine Antigen Reference Stability |
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