Monday, March 23, 2015

Lentiviral Vector Manufacturer, Theravectys, Granted a Manufacturing Establishment by the ANSM in Frence

The French National Agency for Medicines and Health Products Safety (ANSM) granted a GMP pharmaceutical establishment, Theravectys, to produce lentiviral vectors for clinical development from phase I through phase III.

The new GMP facility will be used to handle human cells producing himeric antigen receptors (CARs) and T-cell receptor (TCR)-based cell therapies. 

The Theravectys has over 10 years of experience in lentiviral vector-based therapy and has successfully performed the first vaccination trial performed in humans with lentiviral vectors. (read more here from Yahoo News). 



Global Compliance Seminar (GCS) provides global and FDA regulatory consulting and training services to the FDA-regulated industry in collaboration with the Regulatory Doctor. The US FDA is an Agency under the US Department of Health and Human Services (DHHS).

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