Viral clearance

소개글

"Viral clearance"에 대한 내용입니다.

목차

1. Need for viral clearance evaluation
1) Viral clearance
2) 바이러스 유입 경로

2. Regulatory expectations
1) Viral clearance 연구
2) Viral clearance mechanism 설정

3. Biopharmaceutical downstream processes
1) Harvest depth filtration
2) Low pH treatment
3) Solvent detergent or detergent inactivation
4) Viral filtration
5) Chromatographic steps

4. Future perspective

본문내용

1) Viral clearance 연구
(1) 모델 바이러스의 선정 시 고려사항
Titers to which the virus can be grown to
The presence of a reliable assay for the detection of viruses
- Quantitative PCR (q-PCR): based on the detection of viral nucleic acids
- Viral plaque assay: detect the presence of an intact viral particle
Any health hazards that the viruses may pose to
(2) 모델 바이러스 선정
Viral clearance studies are required to be conducted with at least two model viruses.
- Typically, one model retrovirus (X-MuLV) and one parvovirus (MMV) are selected.
인간 세포주 모델 바이러스
ex. Herpes simplex virus, HIV-1, hepatitis A virus, porcine parvovirus, and possibly encephalomycarditis virus

참고 자료

Abhinav A. S., Viral clearance for biopharmaceutical downstream processes: Pharmaceutical Bioprocessing: 2015: 127-138
Kathryn M. R., Clearance by Protein A, Anion Exchange and Cation Exchange Chromatography Steps: American Pharmaceutical Review: 2015
https://www.americanpharmaceuticalreview.com/Featured-Articles/181836-Viral-Clearance-by-Protein-A-Anion-Exchange-and-Cation-Exchange-Chromatography-Steps/
Viral clearance: the basics on how to conduct effective studies: GE Healthcare Review
https://www.gelifesciences.com/en/us/solutions/bioprocessing/knowledge-center/viral-clearance-study-basics