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重组酵母乙型肝炎疫苗质量分析 被引量:3

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摘要 我单位从美国默沙东制药公司引进重组酵母乙型肝炎疫苗工业化大规模生产技术和生产线,按<重组(酵母)乙型肝炎疫苗制造与检定规程>已生产140多批约1.5亿支、5μg HBsAg/支规格的重组酵母乙型肝炎疫苗.为确立该工艺所生产疫苗批内的均质性和批间的一致性,对各批疫苗各项质量指标的批间差异进行了分析.
出处 《中国生物制品学杂志》 CAS CSCD 2002年第3期189-189,共1页 Chinese Journal of Biologicals
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  • 1梁争论,李艳萍,荆庆,吴小音,李荣成,王建峰,杨继业,钟熙,任玲君,李河民,张华远.一种新型重组(汉逊酵母)乙型肝炎疫苗人体安全性和免疫效果考核[J].中国计划免疫,2004,10(4):193-197. 被引量:37
  • 2赵桂珍 马力 等.国产与进口重组酵母乙肝疫苗阻断母婴传播的研究[J].中华微生物学和免疫学杂志,1998,18(6):463-463.
  • 3Descamps J, Mary A, Rommel E, et al. Release potency tests of hepatitis vaccines. Dev Biol Stand, 1999, 101: 259-294.
  • 4World Health Organization. Requirement for hepatitis B vaeeines made by recombinant DNA techniques (Requirements for Biological Substances No 45, amendment 1997). WHO Technical Report Series, 1999, 889: 94-95.
  • 5Giffroy D, Mazy C, Duchene M. Validation of a new ELISA method for in vitro potency assay of hepatitis B-containing vaccines. Pharmeuropa Bio, 2006, 2006 ( 1 ): 7-14.
  • 6Cuervo ML, Sterling AL, Nicot IA, et ah Validation of a new alternative for determining in vitro potency in vaccines containing hepatitis B from two different manufacturers. Biologicals, 2008, 36 (6): 375-382.
  • 7Vranckx RP. Potency tests for hepatitis B virus vaccines in laboratory animals. Dev Biol Stand, 1983, 54: 63-70.
  • 8World Health Organization. Requirement for hepatitis B vaccines made by recombinant DNA techniques. WHO Technical Report Series, 1989, 786: 38-60.
  • 9Hendriksen CF. Towards eliminating the use of animals for regulatory required vaccine quality control. ALTEX, 2006, 23 (3): 187- 190.
  • 10Hendriksen CF. Replacement, reduction and refinement alternatives to animal use in vaccine potency measurement. Expert Rev Vaccines, 2009, 8 (3): 313-322.

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