Accomplishments

The combination of highly experienced staff, successful track records and cGMP facilities makes Cognate one of the most qualified contract manufacturers of cell-based products in the world today.

Cognate’s staff has played a material role in the submission of numerous approved Investigational New Drug Applications (INDs) or equivalents with the FDA and/or other international regulatory agencies, for clinical trials of cell-based therapeutics. These regulatory applications cover numerous types of stem cells, immune cells and other primary cell types.

Unparalleled Experience and Substantive Track Record

  • Inspected by U.S. FDA to Manufacture cGMP Cell Therapy Products
  • Highly Experienced Staff with an Average Managerial Experience of 15 Years in the Cell Therapy Field
  • Developed Manufacturing Processes for Cell-Based Products
  • Experience Manufacturing Both Autologous and Allogeneic Products
  • Isolated and Expanded Human and Animal Cells from a variety of tissue sources
  • 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
  • Manufacturing for Client Pivotal Clinical Trials
  • Rapid technology transfer and scale up, months from IND submission to clinical readiness

Company Highlights

  • Contract Bioservices and Cell-Based Product Development
  • cGMP Licensed and FDA Inspected Manufacturing Facility
  • State of the Art Research and Development Laboratories
  • Highly Experienced Technical Staff and Management
  • Demonstrated Ability to Rapidly Advance Technology from Concept into the Clinic
  • Customized Service Offerings within a dynamic industry