SERVICES

cGMP Manufacturing

Cognate is a fully-integrated contract bioservices organization providing the highest quality of cGMP cell therapy manufacturing and related services. Cognate leverages its significant expertise to the benefit of the client, by providing a broad spectrum of services targeting the effective commercialization of cell-based products. Our comprehensive service packages support companies in the R&D, Preclinical and Clinical stages, including but not limited to Assay Development, Process Development, Regulatory Services, Scale-up, Automation, and cGMP Cell-Based Manufacturing.

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Process Development

Cognate is a contract services organization providing full product development support to companies commercializing cellular technologies. Cognate’s international experience with a wide range of products, across all stages of commercial development allows us to provide for our clients the most efficient translation from concept to market. The expertise of the process development team, akin to a skunkworks team of cell therapy experts, provides a cost-effective and seasoned team of experts to help overcome virtually any commercial hurdle.

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Cell Therapy Services

Cognate provides an array of technical and specialized manufacturing and product development services internationally with an unparalleled track record and proven expertise with cell-based technologies.  Cognate’s capabilities have been leveraged to the benefit of its clients focused on a broad range of therapeutic applications of both autologous and allogeneic cell-based technologies including, but not limited to stem cells, immune cells, chondrocytes, hepatocytes and other differentiated cell types. Cognate’s collective years of practical real-world development experience in the isolation, culture, and scale-up of such cells from a variety of tissue sources in a commercial environment is our unique value proposition, and is how we effectively help our clients meet their own internal milestones.

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Regulatory Services

Cognate provides international development, manufacturing and regulatory support to companies developing cell-based and regenerative medicine technologies. Cognate has outstanding real-world experience in navigating the evolving international commercial regulatory pathways required for a variety of different types of product approvals. In parallel with such regulatory support services, Cognate’s international experience in translating cGMP manufacturing between countries can effectively help our clients expand their product offerings across the world.

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