Our experience in the development and manufacturing of autologous and allogeneic cellular immunotherapies is unparalleled. Cognate’s largest personalized cellular immunotherapy production to-date 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 up to 86 clinical sites across the US, Canada, Germany, and the UK.
Cognate's experience with immunotherapy continues to expand, but currently includes a wide variety of different types of cell and gene-based therapeutics including but not limited to: T-cell, CAR-T, TCR, MILs, DC, NK, HSC, hu-MSC, MSC, BMSC, fibroblasts as well as a host of other cell types. Our team has held primary manufacturing responsibility for drugs in development from pre-clinical through product approval, with significant experience in the clinical-to-commercial bridge including working with our clients in the preparation for commercial approval. We have deep experience in the development, manufacturing, supply chain, logistics, and regulatory requirements for different types of products, both autologous and allogeneic, and include primary cells, stem cells, immune cells, and a variety of cell-mediated gene therapeutics.
Our comprehensive regulatory experience means Cognate is an expert in addressing the various pieces of the puzzle that must come together to effectively manage the process needle-to-needle. We can efficiently and successfully integrate all the necessary components of your personalized cell therapy process. Let’s discuss how we can be the optimal partner and help you get your products to market.