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The combination of highly experienced staff and GMP facilities makes Cognate BioServices one of the most experienced contract manufacturers of cell-based products in the U.S. today. Cognate is a fully-integrated contract BioServices organization providing the highest level of scientific and management expertise to clients who are focused on the commercialization of cell-based products. Our comprehensive service package supports companies in the specific areas of Preclinical Research, Assay Development, Regulatory Services, Process Development, and cGMP Cell-Based Manufacturing. Cognate has outstanding expertise to provide guidance or take projects from start to finish. Cognate provides cGMP compliant manufacturing to support client efforts to bring their product to the clinic. Cognate’s staff has played a material role in the submission of 18 approved Investigational New Drug Applications (INDs) with the FDA for clinical trials of cell-based therapeutics in the U.S. These INDs cover numerous types of stem cells, immune cells and other primary cell types. Cognate Memphis was inspected by the US FDA in 2009. | ||||||||||||||||||
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Cognate provides full development and cGMP manufacturing services to companies and institutions engaged in development of cell-based products. Cognate has outstanding expertise to provide consultation or take projects from start to finish. With over 200 years of combined cell therapy and cGMP experience, the Cognate team offers a broad variety of management and support services to rapidly advance technology from early research stages through clinical and process development. | ||||||||||||||||||
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Cognate was formed to provide a broad range of preclinical, development and clinical phase services to institutions, biotechnology companies and large health care companies. Cognate applies the know-how and expertise of its scientific and technical teams to successfully develop biotechnology products across multiple cell-based technology platforms. | ||||||||||||||||||
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Cognate offers a broad range of analytical test methods, development and testing services for cell-based products. Our laboratory experts understand assay development for early product research, process development and cGMP in-process and release testing. | ||||||||||||||||||
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Cognate's team works with clients to support planning, performance and analysis of preclinical studies. The expertise of the process development team provides a cost-effective solution for product development and clinical phase planning. We offer development services in cell and molecular biology, immunological testing and customized process solutions. We provide regulatory support for cell-based and regenerative medicine products and technologies. | ||||||||||||||||||
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