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논문 기본 정보

자료유형
학술저널
저자정보
Tae Jun Park (National Institute of Food and Drug Safety Evaluation) Chan Woong Choi (National Institute of Food and Drug Safety Evaluation) Ho Kyung Oh (National Institute of Food and Drug Safety Evaluation) Jae Ok Kim (National Institute of Food and Drug Safety Evaluation) Byung Kuk Kim (National Institute of Food and Drug Safety Evaluation) Hyun Kyung Kang (National Institute of Food and Drug Safety Evaluation) Eun Jeong Kwon (National Institute of Food and Drug Safety Evaluation) Eun Jeong Gweon (National Institute of Food and Drug Safety Evaluation) Sang Jin Park (National Institute of Food and Drug Safety Evaluation) Ho Il Kang (National Institute of Food and Drug Safety Evaluation) Ki Kyung Jung (National Institute of Food and Drug Safety Evaluation) Sang Mi Park (National Institute of Food and Drug Safety Evaluation) Ji Hye Kim (National Institute of Food and Drug Safety Evaluation) Ki Won Han (National Institute of Food and Drug Safety Evaluation) Ja Young Jeong (National Institute of Food and Drug Safety Evaluation)
저널정보
한국독성학회 Toxicological Research Toxicological Research Vol.33 No.3
발행연도
2017.6
수록면
225 - 231 (7page)

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초록· 키워드

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National reference standards (NRSs) for biologics are established through potency estimation by a multicenter joint study of standard materials used in the approval process for national lot release and quality control of vaccines, blood products, and other biologics. In this study, a stability evaluation was conducted to determine whether the potency of NRSs for six blood products was being maintained at a consistent level in Korea. The present study conducted real-time stability tests via in-vivo/in-vitro bioassay on NRSs for blood coagulation factor VIII concentrate (2nd standard), antithrombin concentrate, prekallikrein activator, anti-hepatitis B immunoglobulin, blood coagulation factor IX concentrate, and anti-tetanus human immunoglobulin, as well as a trend analysis using cumulative annual results. The real-time stability test results showed that the mean potency of six NRSs was all within the control limit. In the trend analysis, the potency of NRS for blood coagulation factor VIII concentrate (2nd standard) showed a decreasing trend, while the potency of all other products had been stably maintained. The present study confirmed that the mean potency of NRSs for six blood products had been stably maintained in Korea. The findings of the present study establish a foundation that can ensure the quality of NRSs for biologics in Korea, and it is expected to make a major contribution to the supply of high-quality biologics.
#National reference standard #Blood product #Real-time stability test #Trend analysis

목차

INTRODUCTION
MATERIALS AND METHODS
RESULTS
DISCUSSION
ACKNOWLEDGMENTS
REFERENCES

참고문헌 (12)

참고문헌 신청
Knezevic, I / 2009 / Stability evaluation of vaccines: WHO approach / Biologicals 37:357~359 google schola World Health Organization / 2011 / WHO manual for the establishment of national and other secondary standards of vaccines (Ordering code: WHO/IVB/11.03) / WHO google schola World Health Organization / 1992 / Annex 2: Guidelines for national authorities on quality assurance for biological products google schola ICH / 2003 / Stability testing of new drug substances and products, Q1A(R2), step 4 / ICH google schola Epstein, J.S / 2012 / Best practices in regulation of blood and blood products / Biologicals 40:200~204 google schola

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