Process and Assay Development and Optimization

Cognate can handle internally or via a third party any of your needs when it comes to product characterization and release. Cognate has experience with rapid release testing, something that is critically important in patient populations that are critically ill with limited availability to wait for what can be long periods of product testing. We have experience in the development and optimization of a variety of manufacturing processes and related assays, including fully and semi-closed systems, unit based automation, process characterization, potency, viral integration, purity, a variety of immune assays often used in cellular immunotherapy products and various assays used in the qualification and release of gene modified products. Reach out to us here and let us describe how we can help.

Additional Experience:

  • Cell product characterization, in process QC testing, analytical development and optimization, assay scale up, assay validation, and lot release assays for identity, purity and potency and other measures as appropriate for living cellular product characterization.
  • Method development for scale up, technology innovation, equipment and/or closed system integration
  • Development and integration of fully custom automated or unit based automated solutions
  • Third party vendor collaboration for custom technology development
  • Qualification and validation for pivotal trials or registration