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Cognate Compliant with EU GMPs

For the manufacture of advanced therapeutic medicinal products

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Cognate BioServices, a contract development and manufacturing organization (CDMO) in the global cellular therapies industry, has received a statement of compliance for the manufacture and development of advanced therapy medicinal products (ATMPs) for EU/UK.
 
“We’re very proud to announce that we are now in a position to serve patients in the EU and the UK with our Memphis-based commercial manufacturing team and state of the art GMP manufacturing facility,” said J. Kelly Ganjei, chief executive officer, Cognate BioServices. “We have built an incredible company with a tenured group of manufacturing and quality experts of the highest caliber and a first class facility in which we can supply critical, life-saving therapies to patients in multiple geographies. This milestone is a precursor to our goal of releasing commercial products into the EU. Cognate has built a growing team of over 250 members during our commercial readiness rollout, and our execution of this milestone is a testament to Cognate’s leadership and vision in the cell and gene therapy industry.”

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