Cognate BioServices, Inc. (Memphis, TN) receives Statement of Compliance to EU Good Manufacturing Practice for manufacture of Advanced Therapeutic Medicinal Products
Memphis, June 10, 2019 – Cognate BioServices, Inc., a leading contract development and manufacturing organization (“CDMO”) in the global cellular therapies industry, today announced that It 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. 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. I am especially proud of and grateful to our entire team for the tremendous dedication and hard work that has gotten us to this milestone.”
-J. Kelly Ganjei, CEO Cognate BioServices
About Cognate BioServices
Cognate BioServices is a leading contract bioservices organization providing the highest level of scientific and management expertise in the development, manufacturing and related support services for personalized cell therapy products. Cognate provides full development and cGMP manufacturing services to companies and institutions engaged in the development and manufacture of cell-based products, with a competitive edge in the cellular immunotherapy field. The combination of highly experienced staff, international experience, successful track records and commercial ready cGMP facilities makes Cognate one of the most qualified contract manufacturers of cell and gene based products in the world today. Please visit www.cognatebioservices.com for more information