Unparalleled Cellular Immunotherapy Experience

Cognate has unparalleled experience in the large-scale manufacturing of both autologous and allogeneic cellular immunotherapy products that utilize cell and cell-mediated gene therapy technology.

Cognate’s team of experts have played a material role in the submission of numerous approved Investigational New Drug Applications (INDs) and new Biologic Drug License Applications (BLA)’s or equivalents with the FDA and/or other international regulatory agencies, including PAI/PLI readiness activities and final inspections.

Our experience in the development and manufacturing of drugs in the cellular immunotherapy space is unparalleled, Cognate’s largest clinical grade production was for an autologous dendritic cell vaccine product and associated placebo that was used in a large phase III clinical trial. The starting materials (tumor and leukapheresis) and final product came from and shipped to more than 80 clinical sites in 4 countries.

Cognate’s experience with immunotherapy includes a wide variety of different types of cell and gene-based therapeutics including but not limited to: T-cell, CAR-T, TCR, TIL, MIL, DC, NK, HSC, hu-MSC, MSC, BMSC, and others. Our team has held primary responsibility for drugs in development from pre-clinical through product approval, with significant experience in the clinical to commercial bridge. We have deep experience in regulatory applications for numerous different types of products, both autologous and allogeneic, and ranging from primary cells, to stem cells, to immune cells, cell-mediated gene therapy and everything in between.
This regulatory experience means Cognate is an expert in addressing the various pieces of the puzzle that must be completed to effectively manage the patient-to-patient process.

We can efficiently and successfully integrate all the right components of your personalized cell therapy process. Let us show you how we can be the optimal partner and help you get your products to market.