In Vitro Safety Studies
Cell culture tests can detect a wide spectrum of viruses by cytopathic effect, hemadsorption, hemagglutination, or probing with specific fluorescent antibodies. All tests are fully validated and are performed as standard with appropriate matrix interference controls. ViruSure has significant experience in developing protocols to test even highly interfering test samples.
What our Clients SayHK Inno. n. , (South Korea)
They are extremely professional, knowledgeable and very supportive. Also they are well understanding of regulatory aspects. They respond very promptly to questions and requests throughout the project. We are very satisfied working with Virusure.
A Range of Available In Vitro Tests + Assays
ViruSure’s Tech Gate facility in Vienna has been established with the goal of providing high quality in vitro testing for biopharmaceutical products.
A strict segregation concept together with full ICH compliant assay validation ensures trustworthy test results. Our team is highly trained and responsive to our customers’ needs. We can deploy both routine assays as well as custom test panels to meet your product’s specific requirements.
In vitro adventitious agent testing
The in vitro assay uses a selection of cell lines with a proven history in the detection of a wide range of potential virus contaminants. It is used both in the testing and characterization of recombinant cell banks, as well as in the testing of raw materials (e.g. bovine serum). Cell lines include Vero, MRC-5, HeLa and CHO.
Retrovirus infectivity testing
Many cells (especially cells of rodent origin) endogenously express retrovirus particles, or contamination may be introduced into the cell line exogenously. In vitro assays are used to detect the presence of replication competent retroviruses in recombinant cell banks or bulk harvests. Cell lines include PG4 S+L-, Mus Dunni, XC.
In vitro assay for bovine virus detection
(9CFR in vitro assay)
Bovine viruses can potentially contaminate biologics and biotechnology products due to exposure to bovine derived media components (e.g. FBS). This assay is used to amplify and detect by cytopathic effect, hemadsorption or probing with virus specific antibodies, known bovine contaminants and other contaminating bovine viruses.
In vitro assay for porcine virus detection
(9CFR in vitro assay)
Porcine viruses can potentially contaminate biologics and biotechnology products due to exposure to porcine derived reagents (e.g. trypsin). This assay is used to amplify and detect by cytopathic effect, hemadsorption or probing with virus specific antibodies, known porcine contaminants and other contaminating porcine viruses.
In vitro adventitious agent testing is routinely performed on a minimum of 3 cell lines. Vero and MRC-5 cells are almost always used, while the third cell line is selected based on the species of the producer cell line or the origin of the raw material.