Scope and practicality of in vivo testing for adventitious agents

Developments in Biologicals

Volumn 123, Issue , 2006, Pages 147-152

  Whiteman, M D ^a,b  

^a BioReliance Corporation   (United States)

^b BioReliance   (United States)

Author keywords

Adventitious viral contaminants; Biologicals testing; In vivo virus screen

Indexed keywords

ANIMAL; CHICK EMBRYO; CONFERENCE PAPER; CULTURE TECHNIQUE; DRUG CONTAMINATION; GUINEA PIG; HUMAN; ISOLATION AND PURIFICATION; METHODOLOGY; MOUSE; PATHOGENICITY; REPRODUCIBILITY; VIRUS; YOLK SAC;

ANIMALS; CELL CULTURE TECHNIQUES; CHICK EMBRYO; DRUG CONTAMINATION; GUINEA PIGS; HUMANS; MICE; REPRODUCIBILITY OF RESULTS; VIRUSES; YOLK SAC;

EID: 33644611262     PISSN: 14246074     EISSN: None     Source Type: Book Series    
DOI: None     Document Type: Conference Paper

References (10)

1. Code of Federal Regulations: Biological Products: General. Title 21, Part 600.3 (US Government Printing Office, Washington, DC), 2003.
2. Code of Federal Regulations: Animals and Animal Products. Title 9, Part 113.53 (US Government Printing Office, Washington, DC), 2003.
3. Jacobs JP, Magrath DI, Garrett AJ, Schild: Guidelines for the acceptability, management and testing of serially propagated human diploid cells for the production of live virus vaccines for use in man. J Biol Stand 1981; 9: 331-342.
4. FDA/CBER: Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (FDA/CBER, 1993) Rockville, MD: Food and Drug Administration, Center for Biologics Evaluation and Research, 1993.
5. FDA/CBER: Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use (FDA/CBER, 1997) Rockville, MD: Food and Drug Administration, Center for Biologics Evaluation and Research, 1997.
6. FDA/CBER: Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy (FDA/CBER, 1998) Rockville, MD: Food and Drug Administration, Center for Biologics Evaluation and Research, 1998.
7. International Conference on Harmonization: Guideline on Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin (ICH 5A, 1997) Geneva, Switzerland: International Conference on Harmonization, 1997.
8. International Conference on Harmonization: Guideline on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used in the Production of Biotechnological/Biological Products (ICH Q5D, 1997) Geneva, Switzerland: International Conference on Harmonization, 1997.
9. EMEA/CPMP (European Agency for the Evaluation of Medicinal Products. Committee for Proprietary Medicinal Products): Note for Guidance on the use of Bovine serum in the manufacture of human biological medicinal products. London, 2003, pp 1-8.
10. Fenno J, Luczak J, Moore A, Poiley J, Raineri R, Whiteman M: The characterization of transformed cell substrates. BioPharm 1988; September: 36-42.