메뉴 건너뛰기




Volumn 21, Issue 1, 2002, Pages 57-83

Validation of biopharmaceutical purification processes for virus clearance evaluation

Author keywords

Biopharmaceutical; Biosafety testing; Viral clearance; Viral safety; Viral validation

Indexed keywords

CYCLIC GMP; VACCINE;

EID: 0036229888     PISSN: 10736085     EISSN: None     Source Type: Journal    
DOI: 10.1385/mb:21:1:057     Document Type: Review
Times cited : (40)

References (45)
  • 1
    • 0008851194 scopus 로고    scopus 로고
    • Biologicals Control Act of 1902 (1902)
  • 19
    • 0008812770 scopus 로고    scopus 로고
    • Office of Biologics Research and Review, Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use (Food and Drug Administration, Bethesda, MD, 1987)
  • 20
    • 0005613142 scopus 로고
    • Notice on the registration of drugs: Requirements for validation studies to demonstrate the virus safety of drugs derived from human blood or plasma
    • (1994) Bundesanzeiger , vol.84 , pp. 4742-4744
  • 22
    • 0008851427 scopus 로고    scopus 로고
    • The European Agency for the Evaluation of Medicinal Products, Human Medicines Evaluation Unit - CPMP Biotechnology Working Party Note for Guidance on Virus Validation Studies: the Design, Contribution and Interpretation of Studies Validating the Inactivation and Removal of Viruses, (CPMP/BWP/268/95 Final Version 2, Canary Wharf, London, 1996)
  • 23
    • 0008839472 scopus 로고    scopus 로고
    • The European Agency for the Evaluation of Medicinal Products, Human Medicines Evaluation Unit - CPMP Biotechnology Working Party Medicinal Products Derived from Human Plasma, (CPMP/BWP/268/95 Final Version 2, Canary Wharf, London, 1996)
  • 24
    • 0008838666 scopus 로고    scopus 로고
    • Office of Biologics Research and Review, Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (Food and Drug Administration, Bethesda, MD, 1993)
  • 25
    • 0008828535 scopus 로고    scopus 로고
    • Office of Biologics Research and Review, Draft Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use (Food and Drug Administration, Bethesda, MD, 1994)
  • 26
    • 0008833021 scopus 로고    scopus 로고
    • Center for Biologics Evaluation and Research, Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use (Food and Drug Administration, Rockville, MD, 1997)
  • 27
    • 0008813387 scopus 로고    scopus 로고
    • ICH Topic Q5A. Step 4 Consensus Guideline, Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, CPMP/ICH/295/95. The European Agency for the Evaluation of Medicinal Products, Human Medicines Evaluation Unit, Canary Wharf, London (1997)
  • 28
    • 0029806575 scopus 로고    scopus 로고
    • Validation: Ensuring the accuracy of scaled-down chromatography models
    • (1996) Biopharm. , vol.9 , Issue.9 , pp. 51-54
    • Sofer, G.1
  • 30
    • 84886493425 scopus 로고
    • Freezing and thawing serum and other biological materials
    • (1992) Art to Science , vol.11 , Issue.2 , pp. 1-7
  • 31
    • 0003228192 scopus 로고
    • ICH guideline on "validation of analytical procedures: Definitions and terminology; availability,"
    • 1 March
    • (1995) Federal Register , vol.4 , pp. 11259-11262
  • 32
    • 0029852635 scopus 로고    scopus 로고
    • Process validation for virus removal. Considerations for design of process studies and viral assays
    • (1996) BioPharm. , vol.9 , Issue.9 , pp. 42-50
    • Darling, A.J.1    Spaltro, J.J.2
  • 34
    • 0002570977 scopus 로고
    • Validation of immunological and biological assays
    • (1995) Biopharm. , vol.NOV. , pp. 36-42
    • Little, L.E.1
  • 35
    • 0008833022 scopus 로고    scopus 로고
    • United States vs Barr Laboratories, Inc.; Civil Action No. 92-1744, U.S. District Court for the District of New Jersey; 812F. Supp. 458; 1993 U.S. Dist. Lexis 1932; 4 February 1993, as amended 30 March 1993
  • 38
    • 0008838008 scopus 로고    scopus 로고
    • Note for Guidance on Minimizing the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products - CPMP/CVMP EMEA/410/01 - February 2001
  • 39
    • 0008851195 scopus 로고    scopus 로고
    • Notification of the Safety Requirements for Pharmaceuticals Made From Body Components of Cattle, Sheep or Goats for the Protection Against the Risk of Transmission of BSE and Scrapie - BGA, Germany Feb. 1994
  • 40
    • 0008862725 scopus 로고    scopus 로고
    • Notification Concerning the Approval Registration of Pharmaceuticals of 28 March 1996 Protection Against Pharmaceutical Product Risks, Level II BfArM, Federal Institute for Pharmaceuticals and Medicinal Products, Germany


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.