Our innovative process development and assay design team has a significant depth of cell-based therapy experience ranging from academic to hospital/clinical and industry institutions. This spectrum of experience provides our clients with access to a team with a full 360 view of the product lifecycle. Our team has demonstrated experience in the scale-up of simple and complex processes and using custom and off-the-shelf equipment and technology. We have further experience in various closed-system integrations and have even worked with third-party vendors for fully custom automation solutions.
Cognate's PD, AD, and Innovations team work hand in hand with your dedicated manufacturing teams and function as one resource to help you commercialize your products safely and effectively. As a fully integrated team, we have developed and integrated custom-automated or unit-based automated solutions at many stages in the development process and are able to effectively assess process change feasibility and robustness in collaboration with you and your team.
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At Cognate BioServices, our integrated scientific team has more than 50 years of combined experience. We work collaboratively with client scientists, clinical sites, vendors, and your dedicated team to assess, at any step along the way, any potential process and analytical solutions that will help create a more robust product.
Our team's hands-on expertise spans a wide variety of autologous and allogeneic cell types and starting materials, including but not limited to: Natural Killer (NK) Cells, MILs, Dendritic Cells (DC's), T-Cells, Car-T, BMSC's, MSC's, Whole Blood, apheresis, leukapheresis, tumor isolate, and a variety of Stem cells.
Cognate works with clients collaboratively at all stages of development on risk mitigations, investigations, change controls, development, assessment, and characterization of critical process parameters, and up to PPQ's as we prepare for pre-approval inspection. Finally, in preparation for commercialization, Cognate can work with you and your team to perform integrated small scale/at scale process limit evaluation studies to support qualification and validation activities for pivotal trials or registration.