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In vivo Services

ViruSure’s in vivo facility is fully GMP and GLP compliant and has been established to provide a high quality pathogen free environment for performing in vivo tests. A strict segregation concept together with full GMP compliant validation of the facility air flow and associated systems ensures trustworthy test results. A range of in vivo tests are offered by ViruSure as summarised below:

Prion Bioassays

The titration of samples from prion clearance studies in hamsters and/or mice is required where insufficient assurances around the level of prion removal can be provided by in vitro systems for prion detection like the Western blotting. As detailed in recent EU guidance on the performance of prion clearance studies, titration of the output samples in an animal bioassay may be required. In this instance, the samples are titrated by LD50 assay in mice or hamsters, depending on the type of TSE strain used in the prion clearance study. Because of the slow nature of TSE disease, these assays may require housing of the animals from 6 months up to 1 year.

In vivo advenititous agent testing

In vivo assays for the detection of virus contaminants are comparable to the general in vitro adventitious agent assays. The assays are performed in animal models by the inoculation of the test article into adult mice, suckling mice, embryonated chicken eggs and/or guinea pigs. The end point of the test is the detection of pathogenic viruses either by observation of clinical symptoms or via heamagglutination. This test is generally only required for the characterisation of cell banks, and is not routinely performed on production harvests (although this test may be requested for certain classes of product).

Tumorigenicity Testing

Tumorigenicity is defined as the process by which cells form tumors when inoculated into animals (generally an immunosuppressed animal model). Tumorigenicity is a characteristic of the immortalized cells themselves, rather than of the agents or components present in them. Tumorigenicity testing is required by FDA, WHO and EU guidelines for vaccine cell substrates used for the manufacture of human vaccine products. Generally 107 test cells and positive control tumor cells suspended in 0.2 mL are administered by the subcutaneous route into immunosupressed animals. Generally cells from the end-of-production passage level are used for this testing, and the number of animals developing tumours compared with a positive control tumor cell line (e.g. HeLa). Cell lines demonstrated to be tumorigenic may require additional characterisation via oncogenicity testing.

Oncogenicity Testing

Oncogenicity testing is designed to assure that agents that could immortalize cells and endow them with the capacity to form tumors are not present in a cell substrate. If a vaccine is manufactured in a cell substrate that has a tumorigenic phenotype, this cell line might carry a higher theoretical risk of containing oncogenic substances (e.g. oncogenes or oncogenic viruses). All tumours that develop in oncogenicity study need to be examined for the presence of DNA from the species that the cell substrate was derived from, as well as from the animal in which the oncogenicity testing was performed.

Virusure GmbH

Donau-City-Straße 1, A-1220 Vienna, Austria.
Phone: +43-(0)1-2699120
Fax: +43-(0)1-2699120/22