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Texcell is a world-renowned service company that provides viral safety and immunology services in full compliance with GLP and GMP standards. Since 1987 and thanks to our in-depth experience of providing viral safety testing and virus validation studies, we have provided support to a large number of products now licensed by the FDA, the EMEA and the MHW: recombinant proteins, monoclonal antibodies, vaccines, gene therapy products, medical devices and other products of human or animal origin, such as blood-derived products, heparin, hyaluronic acid and collagen. Texcell is also your central lab for pre-clinical and clinical trials. We offer a dedicated technology platform in immunology, together with comprehensive assay development (optimization and validation) under GLP conditions for monitoring humoral or cell-based immune responses. Meeting the authorities' requirements is one of the key points when evaluating the biosafety of medicinal products. A product must be analysed at each development stage, depending on the regulatory body concerned. Texcell makes particularly sure that it applies the latest guidelines published by the EMEA, FDA and ICH. Texcell also works with a number of independent experts in biology, virology and immunology who help draw up reports for submission to the authorities. Furthermore, Texcell’s own expert staff will willingly help you present the data generated in studies that we carry out on your behalf to the authorities. The excellence of our study designs and protocols is reinforced by our endorsement of project management. Today, the development time for a new molecule has to be as short as possible. Viral safety testing, virus validation and clinical studies need to be continually improved in order to optimize therapeutic strategies. Texcell mobilises the people, protocols and tools needed to complete your project successfully. Your dedicated project manager will provide a weekly progress report. As your partner, our top priority is the achievement of your goals. This web site will help you identify the services and protocols that we offer in viral safety testing, virus and prion validation and immunoprofiling.
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