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Volumn 52, Issue 4, 2009, Pages 293-301

Filter preconditioning enables representative scaled-down modelling of filter capacity and viral clearance by mitigating the impact of virus spike impurities

Author keywords

Filter fouling; Flow decay; Log reduction value (LRV); Spiking study; Viral clearance; Viral safety

Indexed keywords

FILTER FOULING; FLOW DECAY; LOG REDUCTION VALUE (LRV); SPIKING STUDY; VIRAL CLEARANCE; VIRAL SAFETY;

EID: 66149112921     PISSN: 08854513     EISSN: None     Source Type: Journal    
DOI: 10.1042/BA20080133     Document Type: Article
Times cited : (24)

References (23)
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    • 0003478671 scopus 로고    scopus 로고
    • European Agency for the Evaluation of Medicinal Products , European Agency for the Evaluation of Medicinal Products, London, U.K
    • European Agency for the Evaluation of Medicinal Products (1996) Note for Guidance on Virus Validation Studies, European Agency for the Evaluation of Medicinal Products, London, U.K.
    • (1996) Note for Guidance on Virus Validation Studies
  • 7
    • 0004125932 scopus 로고    scopus 로고
    • U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research , U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Bethesda, MD
    • U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research (1997) Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Bethesda, MD
    • (1997) Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use
  • 8
    • 67650992328 scopus 로고    scopus 로고
    • International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (1998) Guidance on Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin, Q5A, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva
    • International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (1998) Guidance on Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin, Q5A, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva
  • 10
    • 57649236847 scopus 로고    scopus 로고
    • Parenteral Drug Association PDA
    • Parenteral Drug Association (PDA) (2005) PDA J. Pharm. Sci. Technol. 59, S2
    • (2005) PDA J. Pharm. Sci. Technol , vol.59


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.