Clinical and Commercial Manufacturing

Cognate’s team has over the last 25+ years, been on many sides of the product development table, with highly relevant experience in the venture capital, operations, consulting, therapeutic product development, and contract services business we know what it takes to get drugs from concept to approval. More importantly, we have the right experience, processes and systems in place to enable a client to successfully transition from clinical development into commercial approvals, regardless of geography and regulatory environment.

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.

Many drug developers in the cell and cell-mediated gene therapy field are faced with the build-vs-buy scenario, for two significant reasons: 1) the sheer capacity required to bridge the clinical to commercial transition and 2) the dedication and experience within the cell therapy CMO world in commercial readiness. The CMO model for pharma has a well established short-term and long-term value proposition, but many of today’s CDMO’s in the cell therapy world have not yet delivered on that same value proposition. Cognate invested significant capital and spent several years building the capacity and capabilities to support our client’s pre-commercial inspections and commercial production. Whether you are in Phase I or Phase III or have an approved product already, Cognate can help with all aspects of your clinical and commercial manufacturing needs. Reach out to us here and lets work together to ease your commercialization worries and create your own individualized value proposition.

MEMPHIS, TN CLINICAL AND COMMERCIAL cGMP MANUFACTURING:
This facility was originally a purpose built-out for autologous cell therapy manufacturing. In 2007, Cognate acquired the manufacturing capacity in Memphis and has since manufactured for many clients in various phases of clinical work and a variety of cell types. One of our largest clinical production campaigns was an autologous product for phase III clinical trials, with products shipped to more than 80 clinical sites in four countries. This facility has supported technology transfer and external manufacturing in close collaboration with partner facilities in Germany, England and other strategic locations. In 2015 Cognate undertook a large scale expansion in support of its commercial readiness plan. In 2017, Cognate opened up its new capacity and began manufacturing a variety of products in late stage clinical trials squarely aimed at rapid commercial approval.

Today we have a team of 270+ members. The majority of the Cognate team is focused on clinical and commercial manufacturing activities. Often initial stages of technology transfer and process development start with a combined team of experts from various parts of our organization to support rapid technology transfer and commencement of manufacturing activities.

Cognate’s Memphis facility is <5 miles from FedEx’s North America super hub and near several life science facilities, University of Tennessee, and St. Jude Children’s Research Hospital. Our proximity to the North American distribution hub insures drop off of patient material in the evening and delivery anywhere in North America by next morning, and enables support of shipment to and from North America, South America and Europe within a 24 hour window.

Clinical and Commercial Manufacturing

  • Process transfer, optimization and validation
  • Large-scale cGMP-compliant cell and cell-mediated gene therapy manufacturing for autologous and allogeneic products from a variety of starting sources (development and implementation of efficient and effective scale up, at the right time developmentally)
  • Ability and expertise to manufacture both adherent and suspension based cells
  • Packaging, storage and shipment to US and international clinical sites (5 minutes from worldwide FedEx hub in Memphis)
  • US and EU cGMP compliant manufacturing suites, including suites specifically designed to support gene modified cell therapy containment
  • Available space for custom configuration in support of large scale rapid commercial capacity expansion
  • Large supply chain expansion space available as volumes increase
  • Experience in multiple geographies to support internationalization of your products