KSBB Journal

The Korean Society for Biotechnology and Bioengineering (한국생물공학회)
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Manufacturing and Establishment of the 2nd National Standard for Varicella Vaccine

수두생바이러스백신 국가표준품 (2차) 제조 및 확립에 관한 연구

  • Kim, Yeon-Hee (National Center for Lot Release, National Institute of Food and Drug Safety Evaluation) ;
  • Kim, Do-Keun (National Center for Lot Release, National Institute of Food and Drug Safety Evaluation) ;
  • Sohn, Yeo-Won (Biopharmaceuticals and Herbal Medicine Evaluation Department, Korea Food & Drug Administration) ;
  • Han, Eui-Ri (National Center for Lot Release, National Institute of Food and Drug Safety Evaluation) ;
  • Kim, Seok-Hwan (National Center for Lot Release, National Institute of Food and Drug Safety Evaluation) ;
  • Lim, Jong-Mi (National Center for Lot Release, National Institute of Food and Drug Safety Evaluation) ;
  • Won, Yun-Jung (National Center for Lot Release, National Institute of Food and Drug Safety Evaluation) ;
  • Yoon, Heui-Seong (National Center for Lot Release, National Institute of Food and Drug Safety Evaluation) ;
  • Jo, Moon-Hee (National Center for Lot Release, National Institute of Food and Drug Safety Evaluation) ;
  • Kim, Kwan-Soo (Biologics Research Division, National Institute of Food and Drug Safety Evaluation) ;
  • Kim, Jae-Ok (National Center for Lot Release, National Institute of Food and Drug Safety Evaluation)
  • 김연희 (식품의약품안전평가원 국가검정센터) ;
  • 김도근 (식품의약품안전평가원 국가검정센터) ;
  • 손여원 (식품의약품안전청 바이오생약심사부) ;
  • 한의리 (식품의약품안전평가원 국가검정센터) ;
  • 김석환 (식품의약품안전평가원 국가검정센터) ;
  • 임종미 (식품의약품안전평가원 국가검정센터) ;
  • 원윤정 (식품의약품안전평가원 국가검정센터) ;
  • 윤희성 (식품의약품안전평가원 국가검정센터) ;
  • 조문희 (식품의약품안전평가원 국가검정센터) ;
  • 김관수 (식품의약품안전평가원 생물의약품연구과) ;
  • 김재옥 (식품의약품안전평가원 국가검정센터)
  • Received : 2010.06.30
  • Accepted : 2010.12.03
  • Published : 2010.12.31
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Abstract

Biological products, such as live varicella vaccine, are composed of biological substances derived from biological organisms. It is very difficult to identify these biologics' characteristics by analysis of simple physical and chemical methods alone. So the reference material is essential in order to evaluate the quality of bilogics. The 1'st national standard for varicella live vaccine was manufactured, established in 2002 and 2003, and have been used for the manufacturer's quality control and national lot release since then. As the lack of its availability and the decrease of its stability, this study was initiated by National Institute of Food and Drug Safety Evaluation (NiFDS) in 2008 to manufacture and establish the 2nd national standard for varicella live vaccine. The candidate material was manufactured from one of domestic manufacterers and the joint research of the NiFDS and manufacturers of varicella live vaccine was conducted to estimate of the reliable virus content. In the collaborative study, 3 laboratories including NiFDS performed the virus content test more than 7 times and all assay results were statistically analyzed. The mean coefficient of variation (CV) was 1.24%, and the geometric mean titre (GMT) variation range of each laboratory was low. On the basis of the results of this study, the candidate material of 2nd national standard for varicella live vaccine was assigned a potency of 4.26 log10 pfu/0.5 mL, when reconstituted in 0.7 mL.

수두 생바이러스 백신과 같은 생물의약품은 다양한 물질이 복합적으로 구성되어 있어 단순한 물리 화학적 분석방법만으로는 그 특성을 규명할 수 없다. 따라서 이러한 생물의 약품의 품질을 평가하기 위해서는 표준품이 필수적이다. 2002년과 2003년에 제조 및 확립한 1차 국가표준품의 재고량 소진 및 역가 감소에 따라 식품의약품안전평가원에서는 수두 생바이러스 백신의 2차 국가표준품을 확립하기 위하여 2008년 용역연구사업을 통해 국내의 수두 생바이러스 백신 제조회사에서 표준품 후보물질을 제조하였으며, 국가표준품 후보물질의 역가산정을 위하여 국내 제조사 및 식품의약품 안전평가원에서 공동연구를 수행하였다. 국내제조사를 포함한 3개의 공동연구 시험소에서 7회 이상의 반복시험을 수행하여 얻은 공동연구 결과를 통계학적으로 분석한 결과 3곳의 공동연구 시험소의 통합역가에 대한 변이계수 (coefficient variation, CV)는 1.24%로 각 시험소간의 기하평균 (GMT) 변동 수준이 매우 낮음을 확인할 수 있었다. 또한, 수두 생바이러스 백신의 2차 국가표준품의 표시역가는 $4.26\;log_{10}\;PFU$/0.5 mL로 산정하였다.

Keywords

References

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