Current challenges in viral safety and extraneous agent testing

Biologicals

Volumn 38, Issue 3, 2010, Pages 335-337

  Mackay, David ^a   Kriz, Nikolaus ^a  

^a EMEA   (United Kingdom)

Author keywords

Extraneous agents; Regulations; Veterinary vaccines; Viral safety

Indexed keywords

VETERINARY DRUG;

ARTICLE; BLUETONGUE; BOVINE VIRAL DIARRHEA; DRUG INDUSTRY; FOOT AND MOUTH DISEASE; GOOD MANUFACTURING PRACTICE; IMMUNOGENICITY; POLYMERASE CHAIN REACTION; PRION DISEASE; PRIORITY JOURNAL; RISK ASSESSMENT; RISK MANAGEMENT; SENSITIVITY AND SPECIFICITY; SEROCONVERSION; VACCINE PRODUCTION; VIRUS GENOME; VIRUS VIRULENCE;

ANIMALS; DRUG CONTAMINATION; HUMANS; RISK ASSESSMENT; RISK FACTORS; VACCINATION; VETERINARY MEDICINE; VIRAL VACCINES; VIRUSES;

EID: 77952955201     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2010.01.014     Document Type: Article

References (7)

1. Kappeler A., Lutz-Wallace C., Sapp T., Sidhu M. Detection of bovine polyomavirus contamination in fetal bovine sera and modified live viral vaccines using polymerase chain reaction. Biologicals 1996, 24(2):131-135.
2. Krakowka S., Ringler S.S., Arumugam P., McKillen J., McIntosh K., Hartunian C., et al. Evaluation of Mycoplasma hypopneumoniae bacterins for porcine Torque Teno virus DNAs. Am J Vet Res 2008, 69:1601-1741.
3. Minimising the risk of transmitting animal spongiform encephalopathy agents via human or veterinary medicinal products. European pharmacopoeia 2008, 558-567. [Chapter 5.2.8], Council of Europe, Strasbourg. 6th ed.
4. EMEA/CVMP/743/00-Rev.2 Revised guideline on requirements and controls applied to bovine serum used in the production of immunological veterinary medicinal products [site accessed 23.10.2009]. http://www.emea.europa.eu.
5. EMEA/532090/2007- Rev.1 CVMP Opinion following an article 33(4) referral on Bovilis BVD and Bovilis BVD-MD site accessed 23.10.2009. http://www.emea.europa.eu.
6. Okada et al. 113th Japan Society of Veterinary Science meeting - poster: Potential risk of contamination of feline live attenuated vaccines by RD-114 virus, 2007.
7. Env recombinant. J Virol 1999, 73:7994-8002.