Abstract ▼

The rabbit pyrogen test is currently practiced for national lot release of complete blood products. While it costs many lives of rabbits, it does not line with the international trend which argues for minimization of animal testing, also represented as 3R. There also has been a need of replacement d

The rabbit pyrogen test is currently practiced for national lot release of complete blood products. While it costs many lives of rabbits, it does not line with the international trend which argues for minimization of animal testing, also represented as 3R. There also has been a need of replacement due to its impossibility in quantification of pyrogen, and also to its sensitivity to condition of animals and technique of examinant.
The purpose of this research project is to develop an alternative pyrogen test for national lot release of complete blood products. Three organizations including MFDS collaborated for this joint research about Limulus Amebocyte Lysate, or LAL (endotoxin), and confirmed the possibility to adopt for Monocyte Activation Test.
We established conditions and methods of LAL (endotoxin) test for 4 Human Normal Immunoglobulin in maltose(pH 4.25) products, 2 Human Tetanus Immunoglobulin products and 1 Factor VIII:C Monoclonal Antibody-purified, Freeze-dried Human Blood Coagulation Factor VIII:C product. The three organizations shared the methods and performed preliminary and final examinations for 20 lots of each products to evaluate research competency.
As a result, we confirmed that endotoxin contents were less than the detection limits of each products, which were 0.1 EU/mL, 1.0 EU/mL and 0.005 EU/IU, respectively, and that the spiked recovery rates fell into the satisfactory range, 50~200%. We also performed Monocyte Activation Test for 3 lots of each 2 Human Normal Immunoglobulin in maltose(pH 4.25), 2 Human Tetanus Immunoglobulin products and 1 Factor VIII:C Monoclonal Antibody-purified, Freeze-dried Human Blood Coagulation Factor VIII:C product that were examined in the LAL test to evaluate the possibility to adopt. We confirmed statistical significance of each value, and the satisfactory endotoxin recovery rate (50~200%).
By this research of alternative pyrogen test for national lot release of complete blood products, we predicated possible substitutability of the rabbit pyrogen test. The results of the research will be used as base line data for introduction of in vitro pyrogen test which is mainly inspected for safety of blood product, and will also contribute to blood product quality improvement.

목차 Contents

• 표지 ... 1
• 자체연구개발과제 최종보고서 ... 2
• 국문요약문 ... 3
• Summary ... 4
• 목차 ... 5
• 연구개발과제 연구결과 ... 6
• 제1장 연구개발과제의 개요 ... 6
• 제2장 연구개발과제의 국내ㆍ외 연구개발 현황 ... 9
• 제3장 연구개발과제의 연구수행 내용 및 결과 ... 12
• 제4장 연구개발과제의 연구결과 고찰 및 결론 ... 29
• 제5장 연구개발과제의 목표달성도 및 관련분야에의 기여도 ... 31
• 제6장 연구개발과제의 연구개발 결과 활용계획 ... 32
• 제7장 참고문헌 ... 33
• 끝페이지 ... 35