The combination of highly experienced staff and GMP facilities makes Cognate one of the most experienced contract manufacturers of cell-based products in the U.S. today. Cognate's staff has played a material role in the submission of 16 approved Investigational New Drug Applications (INDs) with the FDA for clinical trials of cell-based therapeutics in the U.S. These INDs cover numerous types of stem cells, immune cells, and other primary cell types.
Unparalleled Experience and Substantive Track Record
- Inspected and Licensed by California Food and Drug Branch to Manufacture GMP Cell Therapy Products
- Combined Managerial Experience Exceeds 150 Years in the Cell Therapy Field
- Developed Manufacturing Processes for Cell-Based Products
- Experience With Manufacturing of Both Autologous and Allogeneic Products
- Isolated and Expanded Human and Animal Cells
- Developed Innovative Closed Systems for Manufacturing of Adherent and Non-Adherent Cells
- Successful Collaborations with Multiple Companies and Institutions That Have Resulted in Publications in Peer-Reviewed Journals and Presentations at Scientific Meetings
- Conducted Manufacturing for Client Pivotal Clinical Trials
For a detailed PDF file with more information on Cognate's accomplishments, please click here.