Service and Experience

We offer a number of different worldwide manufacturing services and the list keeps growing. 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 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 certificate 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. In 2020 we announced our acquisition of Cobra Biologics, which adds plasmid DNA, viral vector, protein and microbiota development, and manufacturing to our services, as well as additional fill-finish capabilities.

 

Today we employ 500+ people worldwide, with experience spanning the globe in terms of regulatory, manufacturing, clinical, and operations across clinical trials and commercial production and release. Cognate’s Memphis facility is strategically located less than 5 miles from FedEx’s World 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 ensures drop-off of patient material in the evening and delivery anywhere in North America by the next morning and enables support of shipment to and from North America, South America, and Europe within a 24-hour window.

 

 

 

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Is your current CMO struggling to meet your global demand? Let us show you why Cognate is the premier CDMO in global cell & gene therapy!