Worldwide Manufacturing Services Experience

Cognate operates an 80,000+ square feet commercial scale cGMP compliant manufacturing facility in Memphis, TN, within 10 minutes of a FedEx super hub capable of servicing North and South America and Europe.

Our largest phase of clinical grade production was an autologous product for phase III clinical trials, mostly manufactured in Memphis with products coming from and shipped to more than 80 clinical sites in 4 countries. Cognate is currently capable of supporting manufacturing in several geographies on a custom engagement model.

In 2015 Cognate set out to design and build commercial scale capacity for clients developing allogeneic and autologous cell therapy products in the US and the EU/UK. Completing this build in 2016, we then turned our attention to commercial readiness processes and systems, capable of transitioning a client from clinical trials and into commercial production. In the first quarter of 2019, after completion of substantial commercial readiness activities, Cognate received a statement of compliance for EU cGMP, supporting our release of product into the EU/UK. This milestone is a precursor to our goal of releasing commercial products into the EU and the US following a pre-approval or pre-licensing inspection.

In Cognate’s operating history, it has operated facilities and/or manufacturing capacity in Memphis, TN, Sunnyvale, CA, Tel Aviv, Israel, Leipzig, Germany, London, UK, in close proximity to Cambridge, UK, and Lucknow, India. Cognate has supported technology transfer and external manufacturing in close collaboration with partner facilities in Germany and England.
The worldwide manufacturing and related ancillary services we offer to our clients is diverse. Please ask us for more details.

Today we employ 270+ people, with experience spanning the globe in terms of regulatory, manufacturing, clinical and operations across clinical . 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.