Clinical and Commerical Manufacturing
Cognate has unparalleled capabilities for autologous and allogeneic cell and cell-mediated gene therapy products such as CAR-T, TCR, TIL, MIL, DC, NK cell derived cell and cell-mediated gene-based immunotherapies as well as a broad spectrum of regenerative medicine products. Our international manufacturing expertise combined with a broad spectrum of targeted services for effective and optimized commercialization means the highest quality products will get to the patients who need them most -- when they need them.
Process and Assay Development
Our vast experience providing full support for a range of regenerative medicine and blood-derived immunotherapy products throughout all stages of clinical and commercial development. Cognate provides the most efficient translation from concept to market and our experience can help our clients avoid unnecessary bottlenecks and navigate the unexpected.
Ancillary Cell Therapy Manufacturing Services
Access a fully-integrated team of technical, quality assurance, quality control, manufacturing, process development, assay development and operational experts to put together the best plan for getting your product to the patients who need your products the most. Ancillary services are a combination of support, supply chain, logistics and other services that when combined and executed on properly ensure the highest quality product maintains traceability, consistency, and quality through all parts of the patient-to-patient process.
Clinical, Regulatory and Custom Services
Outstanding real-world experience in navigating the evolving international regulatory pathways coupled with know-how in translating cGMP manufacturing between countries across the globe, and at the clinical site, where education of the investigators is critical to maintaining the level of quality and consistency required to execute clinical trials. Migrating from clinical to commercial, we understand how critical close integration with the clinical investigators is. Cognate is equipped with a commercial mindset and the experience to know how changes in technology and approach can impact our clients’ products. Whether it’s a new assay, new sampling plan, new storage procedure or process, or a new device that needs to be modified to scale, or a new element of creating a closed manufacturing process that’s required, Cognate can help.