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학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
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연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
논문 기본 정보
- 자료유형
- 학술저널
- 저자정보
- 발행연도
- 2008.1
- 수록면
- 12 - 20 (9page)
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초록· 키워드
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Validation of viral safety is essential in ensuring the safety of mammalian cell culture-derived biopharmaceuticals, because numerous adventitious viruses have been contaminated during the manufacture of the products. Mammalian cells are highly susceptible to minute virus of mice(MVM), and there are several reports of MVM contamination during the manufacture of biopharmaceuticals. In order to establish the validation system for the MVM safety, a real-time PCR method was developed for quantitative detection of MVM in cell lines, raw materials, manufacturing processes, and final products as well as MVM clearance validation. Specific primers for amplification of MVM DNA was selected, and MVM DNA was quantified by use of SYBR Green I. The sensitivity of the assay was calculated to be 6 × 10-2 TCID50/mL. The real-time PCR method was proven to be reproducible and very specific to MVM. The established real-time PCR assay was successfully applied to the validation of Chinese hamster ovary (CHO) cell artificially infected with MVM. MVM DNA could be quantified in CHO cell as well as culture supernatant. When the real-time PCR assay was applied to the validation of virus removal during a virus filtration process, the result was similar to that of virus infectivity assay. Therefore, it was concluded that this rapid, specific, sensitive, and robust assay could replace infectivity assay for detection and clearance validation of MVM
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참고문헌 (25)
참고문헌 신청
/ 1998 / Guidance on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin; availability / International Conference on Harmonisation
Adamson, S. R / 1999 / Experiences of virus, retrovirus and retrovirus-like particles in chinese hamster ovary (CHO) and hybridoma cells used for production of protein therap
Arden, N. / 2004 / Life and death in mammalian cell culture: strategies for apoptosis inhibition / Trends Biotechnol 22 : 174 ~ 180
Boschetti, N. / 2003 / Stability of minute virus of mice against temperature and sodium hydroxide / Biologicals 31 : 181 ~ 185
Celis, P / 2004 / European regulatory guidance on virus safety of recombinant proteins, monoclonal antibodies and plasma derived medicinal products / Dev. Biol. Stand 118 : 3
Adamson, S. R / 1999 / Experiences of virus, retrovirus and retrovirus-like particles in chinese hamster ovary (CHO) and hybridoma cells used for production of protein therap
Arden, N. / 2004 / Life and death in mammalian cell culture: strategies for apoptosis inhibition / Trends Biotechnol 22 : 174 ~ 180
Boschetti, N. / 2003 / Stability of minute virus of mice against temperature and sodium hydroxide / Biologicals 31 : 181 ~ 185
Celis, P / 2004 / European regulatory guidance on virus safety of recombinant proteins, monoclonal antibodies and plasma derived medicinal products / Dev. Biol. Stand 118 : 3
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