In vivo assays
Moredun Scientific offers a comprehensive portfolio of in vivo biosafety testing services The assays are required at various stages of biopharmaceutical manufacturing as defined by international regulatory guidelines. Studies are conducted in our state of the art GLP accredited animal accommodation.
- In vivo adventitious agent assays screen for viral contaminants not known to cause any cytopathic or other discernable effects in cell culture systems.
- Rodent Antibody Production Tests detect and identify adventitious rodent viruses and are essential assays for rodent cell derived products.
- General Safety Tests, Abnormal Toxicity Tests detect the presence of extraneous toxic contaminants in test articles. They are survival studies, the test article is inoculated into guinea pigs and mice which are observed for 7 days for clinical signs of illness.
- Tumorigenicity studies determine if a cell substrate is capable of forming a tumor after inoculation into mice. These studies may be required for human epithelial cell lines, human cell lines used for live virus vaccine production and cells used in somatic cell or gene therapy. Cell substrates are typically injected into nude (nu/nu) mice which are monitored for signs of tumor formation.
- Oncogenicity studies assess the capacity of cell substrates to immortalize normal cells and endow them with the ability to form tumors in an animal model. Oncogenic activity from cell substrates could be due to either the cell substrate DNA or an oncogenic agent present in the cells. Typically, cell lysates are injected into newborn nude mice or newborn hamsters which are monitored for signs of tumor formation.
- Custom studies can also be established. Please contact us to discuss your specific requirements
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