Chang Hee JUNG, Jae Il LEE, Jung Eun BAE, In Seop KIM
언어
영어(ENG)
URL
https://www.earticle.net/Article/A174403
※ 원문제공기관과의 협약기간이 종료되어 열람이 제한될 수 있습니다.
원문정보
초록
영어
In biopharmaceutical manufacturing, many products are produced by Chinese hamster ovary (CHO) cells. Validation of viral safety is essential in ensuring the safety of CHO cell culture-derived biopharmaceuticals, because CHO cells contain endogenous retrovirus like particles(RVLP). RVLP should be removed and/or inactivated during the manufacture of biopharmaceuticals, and must not be present in the final product. Therefore validated quantitative detection method is required for ensuring the safety of biopharmaceuticals against RVLP. In this study, a TaqManbased real-time quantitative PCR assay to detect RVLP was developed and validated. Specific primers for amplification of RVLP nucleic acid was selected, and RVLP RNA was quantified by use of TaqMan probe. The sensitivity of the assay was calculated to be 2.24×100 copies/μL. The TaqMan-based real-time PCR assay was proven to be reproducible and very specific to RVLP. The established real-time PCR assay was successfully applied to the detection of RVLP during the manufacture of a therapeutic antibody using CHO cells. Therefore, it was concluded that this fast, specific, sensitive, and robust assay is invaluable for detection of RVLP and virus clearance evaluation during the manufacture of CHO cell culture-derived biopharmaceuticals.
한국생물공학회 [The Korean Society for Biotechnology and Bioengineering]
설립연도
1984
분야
공학>생물공학
소개
이 법인은 생물 공학의 발전과 보급에 이바지하고, 회원 상호 간의 연구 협력과 친목을 도모함을 목적으로 한다
1. 생물공학 분야의 발전을 위한 연구 협력
2. 생물공학의 실용화를 촉진시키기 위한 산학 협동
3. 학술연구 발표회, 강연회, 연수회 등 학술활동의 개최
4. 국,영문 학술지,소식지,학술회의 Proceedings 및 학술도서의 발간
5. 생물공학 발전을 위한 정책 건의
6. 기타 국제 교류 등 본 학회의 목적 달성을 위한 제반 활동