Development, standardization and assessment of PCR systems for purity testing of avian viral vaccines

Biologicals

Volumn 38, Issue 3, 2010, Pages 381-388

  Ottiger, Hans Peter ^a  

^a INSTITUTE OF VIROLOGY AND IMMUNOLOGY   (Switzerland)

Author keywords

Avian viral vaccines; European Pharmacopoeia; Extraneous agent; Polymerase chain reaction

Indexed keywords

CRYOMAREX; EPTIFIBATIDE; MAREK DISEASE VACCINE; NEWCASTLE DISEASE VACCINE; RISPENS; UNCLASSIFIED DRUG; VIRUS VACCINE;

ARTICLE; AVIAN ENCEPHALOMYELITIS ENTEROVIRUS; AVIAN INFECTIOUS BRONCHITIS VIRUS; AVIAN LEUKOSIS ONCOVIRUS; AVIAN ORTHOREOVIRUS; AVIAN PNEUMOVIRUS; DRUG PURITY; DRUG QUALITY; GYROVIRUS; ILTOVIRUS; INFECTIOUS BURSAL DISEASE VIRUS; INFLUENZA VIRUS A; MAREK DISEASE; NEWCASTLE DISEASE; NEWCASTLE DISEASE PARAMYXOVIRUS; NUCLEOTIDE SEQUENCE; POLYMERASE CHAIN REACTION; PRIORITY JOURNAL; PROCESS DEVELOPMENT; PROCESS OPTIMIZATION; QUALITY CONTROL; SENSITIVITY ANALYSIS; SEROTYPE; STANDARDIZATION; VACCINE PRODUCTION; VIRAL CONTAMINATION; VIRUS DETECTION; VIRUS STRAIN;

ANIMALS; BIRNAVIRIDAE INFECTIONS; CHICKENS; DRUG CONTAMINATION; INFECTIOUS BURSAL DISEASE VIRUS; NEWCASTLE DISEASE VIRUS; POLYMERASE CHAIN REACTION; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; RISK ASSESSMENT; SPECIES SPECIFICITY; VIRAL VACCINES; VIRUSES;

AVES; AVIADENOVIRUS; AVIAN ENCEPHALOMYELITIS VIRUS; AVIAN INFECTIOUS BRONCHITIS VIRUS; AVIAN LEUKOSIS VIRUS; AVIAN ORTHOREOVIRUS; CHICKEN ANEMIA VIRUS; DUCK ADENOVIRUS 1; GALLID HERPESVIRUS 1; GALLID HERPESVIRUS 2; INFECTIOUS BURSAL DISEASE VIRUS; INFLUENZA A VIRUS; NEWCASTLE DISEASE VIRUS; TURKEY RHINOTRACHEITIS VIRUS;

EID: 77952957064     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2010.01.015     Document Type: Article

References (19)

1. Council of Europe European pharmacopoeia. Editions of the Council of Europe http://www.pheur.org/.
2. van der Kamp M. Replacement, reduction or refinement of animal use in the quality control of veterinary vaccines: development, validation and implementation. Replacement, reduction and refinement of animal experiments in the development and control of biological products 1996, vol. 86:73-76. Karger, Basel, Dev Biol Stand. F. Brown, K. Cussler, C. Hendriksen (Eds.).
3. Castle P. Replacement, reduction and refinement of animal experiments in the development and control of biological products. Alternatives to animal testing: achievements and recent developments in the European Pharmacopoeia 1996, vol. 86:21-29. Karger, Basel, Dev Biol Stand. F. Brown, K. Cussler, C. Hendriksen (Eds.).
4. Bruckner L., Bongers J., Castle P., Flore P.H., Guittet M., Halder M., et al. Three Rs approaches to the production and quality control of avian vaccines. The Report and recommendations of the ECVAM workshop 41. ATLA 2000, 28:241-258.
5. Halder M. Three Rs potential in the development and quality control of immunobiologicals. ALTEX 2001, 18(Suppl):13-47.
6. Lucken R., Stolp R. Identification of extraneous agents and other contaminants. Veterinary vaccinology 1997, 108-109. Elsevier. P.P. Pastoret, J. Blancou, P. Vannier, C. Verschueren (Eds.).
7. Ottiger H.P. Use of PCR for extraneous agent testing in avian vaccines, in: advancing science and eliminating of the use of laboratory animals for development and control of vaccines and hormones 2002, vol. 111. Karger, Basel, Dev Biol23-26.
8. Ottiger H.P. Monitoring veterinary vaccines for contaminating viruses. New diagnostic technology: applications in animal health and biologics controls 2006, vol. 126:309-319. Karger, Basel, Dev Biol. P. Vannier, D. Espeseth (Eds.).
9. Stäuber N., Brechtbühl K., Bruckner L., Hofman M.A. Detection of Newcastle disease virus in poultry vaccines using the polymerase chain reaction and direct sequencing of amplified cDNA. Vaccine 1995, 13:360-364.
10. Häuptli D., Bruckner L., Ottiger H.P. Use of reverse transcriptase polymerase chain reaction for detection of vaccine contamination by avian leukosis virus. J Virol Methods 1997, 66:71-81.
11. Vögtlin A., Bruckner L., Ottiger H.P. Use of polymerase chain reaction (PCR) for the detection of vaccine contamination by infectious laryngotracheitis virus. Vaccine 1999, 17(20-21):2501-2506.
12. Timgren R. Use of RT-PCR for the detection of vaccine contamination by infectious bursitis disease (Gumboro) virus. Dissertation faculty of veterinary medicines 2001, University of Berne.
13. Bruhn S., Bruckner L., Ottiger H.P. Application of RT-PCR for the detection of avian reovirus contamination in avian viral vaccines. J Virol Methods 2005, 123:129-130.
14. Lang K. Detection of Marek's disease virus contamination in poultry vaccines using PCR. Dissertation Faculty of Veterinary Medicines Vetsuisse 2005, University of Berne.
15. Bruckner L., Ottiger H.P. Pre-Validation study for testing of avian viral vaccines for extraneous agents by PCR. Pharmeuropa BIO 2007, 1:73-75.
16. Elgizoli M., Vögtlin A., Bruckner L., Ottiger H.P. Sequence analysis of a Newcastle disease virus contaminating avian vaccines 1998, Union of Swiss Societies for Experimental Biology USGEB, Fribourg, Switzerland, Abstract p. 112.
17. Bootz F., Sieber I., Popovic D., Tischhauser M., Homberger F.R. Comparison of the sensitivity of in vivo antibody production tests with in vitro PCR-based methods to detect infectious contamination of biological materials. Lab Anim 2003, 37:342-351.
18. Bauer B.A., Besch-Willford C.L., Riley L.K. Comparison of the mouse antibody production (MAP) assay and polymerase chain reaction (PCR) assays for the detection of viral contaminants. Biologicals 2004, 32:177-182.
19. Motitschke A., Ottiger H.P., Jungbäck C. Evaluation of the sensitivity of PCR methods for the detection of extraneous agents and comparison with in vivo testing. Biologicals 2010, 38:389-392.