Track Record, Experience and Capabilities

Cognate’s combination of highly experienced staff, successful track record with large scale personalized cell and cell-mediated gene therapies and the commercial capacity, scale and capabilities of our cGMP facility makes Cognate one of the most qualified contract manufacturers of personalized cell and cell-mediated gene therapy products in the world today.

Cognate’s team of experts have 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 a wide variety of different types of cell-based therapeutics, including : CAR-T, TCR, TIL, MIL, DC, NK, MSC, HSC, hUC-MSC’s, and ADSC’s among others. Our team has held primary responsibility for drugs in development from the pre-clinical stage through product approval, with significant capabilities in the clinical to commercial bridge. Our regulatory applications experience covers numerous different types of products, both autologous and allogeneic, and ranging from primary cells, to stem cells, to immune cells and everything in between.

Unparalleled Experience and Substantive Track Record

  • Inspected by the U.S. FDA to Manufacture cGMP Cell and Gene Therapy Products with no 483’s in our operating history
  • Recent audit by QP after expansion and commercial readiness activities resulting in Statement of Compliance to EU GMP for ATMPs
  • Highly Experienced Staff with an Average Managerial Experience of 20+ Years in the Regenerative Medicine and/or Cellular Immunotherapy (RMCIT) Fields
  • Developed a number of optimal manufacturing processes and/or methods for Cell and Gene-Based Products, including, among other processes, unit-based automation and fully-closed devices.
  • Extensive experience in the development and manufacturing of both autologous and allogeneic products
  • Significant and highly specialized capabilities in the isolation and expansion of a variety of different Human and Animal Cells from a wide range of tissue sources.
  • Developed innovative closed systems and other unit-based automation devices and procedures for the isolation and for the manufacturing of adherent and non-adherent cells.
  • Successful International operating history.
  • Well-established track record of successful technology transfer into Cognate’s Memphis facility as well as internationally to various manufacturing collaborators.
  • A selection of our activities have resulted in publications in peer-reviewed journals and presentations
  • Significant experience in the development and manufacturing of clients’ products for pivotal clinical trials and related pre-commercial readiness activities.
  • When needed, Cognate successfully implements rapid technology transfer and scale up, reducing the time from IND submission to clinical readiness to only a few months.

Company Highlights

  • Contract manufacturing, assay development, process development, release assays, cytotoxicity, and restriction assays among others. Cognate is a leader in cell and gene therapies with a specific expertise in cell and cell-mediated immunotherapy manufacturing, with industry-leading experience in autologous and allogeneic cell and gene therapy manufacturing and related activities.
  • cGMP Licensed and FDA Inspected Manufacturing Facility, with an EU cGMP manufacturing certificate, capable of servicing North America, and Europe from our Memphis facility. Additional manufacturing capabilities outside the US available upon request.
  • State of the art PD/AD and Innovation laboratories with unparalleled experience in handling regenerative medicine and blood-derived products.
  • Unparalleled combination of expertise in the organization, including process development, scale-up, pre-commercialization, phase I, phase II, phase III, and commercial production of a wide range of cell and cell-mediated gene therapies and biologics .
  • Demonstrated experience and capability to rapidly advance technology from concept to clinic and commercial.
  • Customized service offerings tailored to the need of our clients.