Virus assay methods: Accuracy and validation

Biologicals

Volumn 26, Issue 2, 1998, Pages 105-110

  Darling, Allan J ^a   Boose, Jeri Ann ^a   Spaltro, John ^a  

^a MA BioServices Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BIOASSAY; DIAGNOSTIC ACCURACY; PRIORITY JOURNAL; VIRUS DETECTION; VIRUS DIAGNOSIS;

EID: 0031726232     PISSN: 10451056     EISSN: None     Source Type: Journal    
DOI: 10.1006/biol.1998.0134     Document Type: Article

References (11)

1. 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.
2. 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).
3. 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).
4. 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.
5. 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.
6. Federal Health Office and Paul Erlich Institute Federal Office for Sera and Vaccines. Notice on the Registration of Drugs: Requirements for Validation Studies to Demonstrate the Virus Safety of Drugs Derived from Human Blood or Plasma, Bundesanzeiger, 84, 4742-4744, 1994.
7. ICH Guideline on "Validation of Analytical Procedures: Definitions and Terminology; Availability", Federal Register, 4, 11259-11262, 1 March 1995.
8. Darling AJ, Spaltro JJ. Process Validation for Virus Removal. Considerations for Design of Process Studies and Viral Assays. Biopharm, 42-50, October 1996.
9. Spearman C, Kaerber G. In: Bibrack, B, Wittmann, G, eds. Virologische Arbeitsmethoden. Stuttgart: Fischer Verlag, 1974, 37-39.
10. Little LE. Validation of Immunological and Biological Assays, Biopharm, November 1995, 36-42.
11. United States v. 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.