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Biodistribution studies provide an essential part in the pre-clinical safety evaluation of novel gene therapy technologies and are necessary to address regulatory concerns. They are designed to investigate the integration or expression of the vector construct in the germ line, the persistence of the vector in the target tissues and dissemination to non-target tissues. Quantitative PCR (Q-PCR) is the method of choice for the detection and quantification of specified gene sequences in biodistribution studies. BioReliance has been investing in and developing Q-PCR methods for virus detection for several years and is a world leader in the application of Q-PCR to viral safety studies, including biodistribution studies. BioReliance will undertake a complete biodistribution study ensuring that critical steps, such as tissue extraction, are conducted under the most stringent conditions and that the tissue samples are in perfect condition to satisfy the requirements of the highly sensitive molecular assays. At BioReliance, these studies are performed in GLP compliant facilities and meet full regulatory requirements.