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Biopharmaceutical Services
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Xenotransplantation Research in Xenotransplantation is, in part, driven by the fact that the demand for human organs for clinical transplantation exceeds the supply. Nonetheless, transplantation of nonhuman cells and tissues may be therapeutic for certain diseases, such as neurodegenerative disorders and diabetes, where human materials are not usually available. However, the potential for cross-species infection by retroviruses, which may be latent and lead to disease years after infection, is a public health concern. Charles River offers validated assays to ensure the absence of adventitious agents in the cells or tissues to be transplanted as well as the absence of retroviruses in patients receiving the transplanted cells or tissues. Our integrated Biopharmaceutical Services Xenotransplantation Testing Program will help you accelerate your efforts to assure product safety and to meet FDA, ICH, and CPMP guidelines. |
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