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TRANSLATIONAL RESEARCH PLATFORM FOR VETERINARY BIOLOGICALS
(DBT-TANUVAS Partnership Programe)
Adventitious Viral Genome Detection in Vaccines or Products of Animal Origin
Backdrop:
 The recent reports on the presence of extraneous viruses such as porcine circovirus and porcine
parvovirus contamination in rotavirus vaccine and the identification of nodovirus in the insect cells
which was used to produce human papilloma virus (HPV) vaccine had cautioned the regulators and
vaccine industry about the need for extensive characterization of the vaccine banks and substrates
 The major sources of extraneous Viruses contamination in vaccine and cell banks are animal
derived raw materials such as porcine trypsin, bovine serum, cell line, source of Virus isolation, etc
used during the vaccine development and production process
 Currently the 9CFR 113 extraneous Virus testing protocol was practiced by vaccine industry to
screen their Virus and cell banks. However, there is an extensive list of bovine, porcine and human
Viruses which are not detected by laborious and time-consuming 9CFR 113 protocol.
 Regulators and manufacturers are in great need of additional testing procedures which may be
useful as adjuncts and replacements for the 9 CFR tests in quality control labs of vaccine
manufacturers.
Technology available
TRPVB has developed a multiplex PCR assay for detection of adventitious Viruses of porcine and
bovine origin
A: The gel picture shows the test samples positive for two viral nucleic acids
M-Marker 100bp ladder; T- Test; N-Negative; P- Porcine viral DNA constructs (n=4)
 TRPVB has developed multiplex PCR assay for screening FBS for five prominent
bovine Viruses and for screening porcine trypsin for six prominent porcine
Viruses
 Initial screening of veterinary vaccines (n=17), human vaccines (n=10), and
trypsin (n=7) at TRPVB indicated that 52% of veterinary vaccines and 10% of
human vaccines and 100% of trypsin showed adventitious viral genome
contamination.
2nd Floor, Central University Building, Madhavaram Milk Colony, Chennai-51.
Phone- 25556275 – 78; E. mail – [email protected]
Optimized validated multiplex PCR to Detect
Bovine Viruses
1.
2.
3.
4.
5.
Bovine Parvovirus (BPV)
Bovine Herpesvirus (BHV)
Bovine CoronavVirus (BCV)
Bovine Pesti Virus (BPeV)
Bluetongue Virus (BTV)
Porcine Viruses
1.
2.
3.
4.
5.
6.
Porcine Circovirus (PCV)
Porcine Parvovirus (PPV)
African Swine Fever Virus (ASFV)
Classical Swine Fever Virus (CSFV)
Swine Vesicular Disease Virus (SVD) and
Porcine Respiratory Reproductive Syncitial Virus (PRRSV)
Samples for testing
The developed assay can detect the viral genomes from animal derived raw materials (Serum and
trypsin), animal clinical/tissue samples, vaccines, research samples, etc.
The amplified PCR products can be further confirmed by sequencing on request
Application of this technology
This assay would be useful for
 Vaccine manufacturers for screening animal derived raw materials used in vaccine
manufacturing
 Vaccine QC testing labs
 R&D laboratories and research institutes
 Animal disease diagnosis laboratories
 Academic institutions
2nd Floor, Central University Building, Madhavaram Milk Colony, Chennai-51.
Phone- 25556275 – 78; E. mail – [email protected]