메뉴 건너뛰기




Volumn 25, Issue 6, 2001, Pages 26-31

Viral clearance strategies for biopharmaceutical safety: Part II: A multifaceted approach to process validation

Author keywords

[No Author keywords available]

Indexed keywords


EID: 0041780677     PISSN: 15342131     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article
Times cited : (6)

References (12)
  • 2
    • 0035139317 scopus 로고    scopus 로고
    • Viral clearance strategies for biopharmaceutical safety, part 1: General considerations
    • H. Aranha, "Viral Clearance Strategies for Biopharmaceutical Safety, Part 1: General Considerations," BioPharm 14 (1), 28-35 (2001).
    • (2001) BioPharm , vol.14 , Issue.1 , pp. 28-35
    • Aranha, H.1
  • 3
    • 0035110750 scopus 로고    scopus 로고
    • Viral clearance strategies for biopharmaceutical safety, part 2: Filtration for viral clearance
    • H. Aranha, "Viral Clearance Strategies for Biopharmaceutical Safety, Part 2: Filtration For Viral Clearance," BioPharm 14 (2), 32-43 (2001).
    • (2001) BioPharm , vol.14 , Issue.2 , pp. 32-43
    • Aranha, H.1
  • 4
    • 0033508929 scopus 로고    scopus 로고
    • Safety issues for plasma derivatives and benefit from NAT testing
    • H. Willkommen, I. Schmidt, and J. Lower, "Safety Issues for Plasma Derivatives and Benefit from NAT Testing," Biologicals 27, 325-331 (1999).
    • (1999) Biologicals , vol.27 , pp. 325-331
    • Willkommen, H.1    Schmidt, I.2    Lower, J.3
  • 6
    • 0032564029 scopus 로고    scopus 로고
    • Guidance on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin
    • "Guidance on Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin," Federal Register 63 (185), 51074-51084 (1998).
    • (1998) Federal Register , vol.63 , Issue.185 , pp. 51074-51084
  • 8
    • 0033059158 scopus 로고    scopus 로고
    • Application of bacteriophages as surrogates for mammalian viruses: A case for use in filter validation based on precedents and current practices in medical and environmental virology
    • H. Aranha-Creado and H. Brandwein, "Application of Bacteriophages as Surrogates for Mammalian Viruses: A Case for Use in Filter Validation Based on Precedents and Current Practices in Medical and Environmental Virology," PDA J. Pharm. Sci. Technol. 53, 75-82 (1999).
    • (1999) PDA J. Pharm. Sci. Technol. , vol.53 , pp. 75-82
    • Aranha-Creado, H.1    Brandwein, H.2
  • 9
    • 0031726232 scopus 로고    scopus 로고
    • Virus assay methods: Accuracy and validation
    • A.J. Darling, J.A. Boose, and J. Spaltro, "Virus Assay Methods: Accuracy and Validation," Biologicals 26, 105-110 (1998).
    • (1998) Biologicals , vol.26 , pp. 105-110
    • Darling, A.J.1    Boose, J.A.2    Spaltro, J.3
  • 10
    • 0026291444 scopus 로고
    • Defective endogenous retrovirus-like sequences and particles of Chinese hamster ovary cells
    • K.P. Anderson et al., "Defective Endogenous Retrovirus-Like Sequences and Particles of Chinese Hamster Ovary Cells," Dev. Biol. Stand. 75, 123-132 (1991).
    • (1991) Dev. Biol. Stand. , vol.75 , pp. 123-132
    • Anderson, K.P.1
  • 11
    • 0009859175 scopus 로고
    • Detection of viruses in recombinant cells by electron microscopy
    • R.E. Spier, J.B. Griffiths, and C. MacDonald, Eds. Butterworth-Heinemann Ltd., Oxford, UK
    • C. Liptrot and K. Gull, "Detection of Viruses in Recombinant Cells by Electron Microscopy," Animal Cell Technology: Developments, Processes, and Products, R.E. Spier, J.B. Griffiths, and C. MacDonald, Eds. (Butterworth-Heinemann Ltd., Oxford, UK, 1991), pp. 653-656.
    • (1991) Animal Cell Technology: Developments, Processes, and Products , pp. 653-656
    • Liptrot, C.1    Gull, K.2
  • 12
    • 0025761580 scopus 로고
    • Genomic organization and expression of endogenous retrovirus-like elements in cultured rodent cells
    • K.K. Lueders, "Genomic Organization and Expression of Endogenous Retrovirus-Like Elements in Cultured Rodent Cells," Biologicals 19, 1-7 (1991). PT
    • (1991) Biologicals , vol.19 , pp. 1-7
    • Lueders, K.K.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.