At Cognate BioServices, we have unparalleled experience in the development, optimization, and scale-up of a variety of complex assays, including process characterization, potency, viral integration, and purity. We’re well-versed in the numerous immune assays often used in cellular immunotherapy products and in the qualification, and release of gene-modified products and offer 3rd party USP <70> testing for our clients who wish to outsource specific assays.
Our capabilities include development, qualification, and validation of assays, including all documentation, for:
Our innovative and collaborative team is able to scale up quickly, has experience with equipment and closed-system integration, and will work hand-in-hand with you and any of your third-party vendors for custom technology development. We’re able to develop and integrate custom-automated or unit-based automated solutions and are able to qualify and validate for pivotal trials or registration.
Cognate has ongoing collaborations with several critical technology vendors to facilitate our clients' access to the latest technologies. Our collaborations in this regard are focused on the rapid translation of products into commercial readiness.
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.