자외선 흡광도를 이용한 유전자재조합의약품 함량 결정과정 분석

• 영문명: Analysis of Protein Content Determination Using UV Absorbance in Recombinant DNA-derived Biologics
• 발행기관: 대한약학회
• 저자명: 강소영(Soyeong Kang) 최진실(JinShil Choi) 엄준호(Joon Ho Eom)
• 간행물 정보: 『약학회지』제64권 제2호(2020년), 173~177쪽, 전체 5쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2020.04.30

영문 초록

This study summarizes the theoretical background of the protein concentration determination process using UV absorbance and proposes the standard calculation formular. We analyzed the protein concentration determination process of recombinant DNA-derived biologics that is inspected by the Ministry of Food and Drug Safety for the last three years (2017-2019) and we found some errors in calculation formular. In addition, we analyzed parameters and acceptance criteria of system suitability test (SST), and we proposed the direction for setting the SST. If the results of this study are widely understood and utilized by product manufacturers and research developers, the calculation of protein concentration using UV absorbance for each product would be simplified and standardized, and contribute to efficient communication between product manufacturers and regulatory authority.

목차

서 론(Introduction)

연구 방법(Research Methods)

결과 및 고찰(Results and Discussion)

결 론(Conclusion)

감사의 말씀(Acknowledgment)

Conflict of Interest

References

키워드

UV Protein Content Absorbance Extinction Coefficient