In vivo biosafety assays are required at various stages in the manufacturing of biopharmaceuticals as defined by international regulatory guidelines. We have a portfolio of regulatory compliant assays with the animal phase conducted in our GLP accredited animal accommodation.
In vivo adventitious agent assays screen for viral contaminants not known to cause any cytopathic or other discernible effects in cell culture systems. The test article is inoculated into a range of animal species which increases the probability of virus detection. A combination of embryonated eggs, adult mice and suckling mice are generally used with guinea pigs, rabbits and other species included if appropriate. The animals are observed over a period of time for signs of ill health. These assays detect the presence of viral contaminants but do not identify the nature of the contaminant. Any positive results require further investigation.
Rodent Antibody Production Tests detect and identify adventitious rodent viruses and are essential assays for rodent cell derived products. Virus antibody-free rodents are inoculated with the test article and observed over a 28 day period. Serum samples are analysed (mainly by the ELISA technique) for the detection of antibodies to a panel of viruses. A positive test indicates that the test article contains a contaminating virus.
General Safety Tests and 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 immunocompromised 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.
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 immunocompromised mice or hamsters which are monitored for signs of tumor formation.
Custom studies can also be established. Please contact us to discuss your specific requirements