 | |
 |
The Establishment for Gene and Cell Therapy (ETGC) is dedicated to the preparation and production of gene and cell therapy products for regulatory pre-clinical studies (toxicology and pharmacology) and clinical studies (Phase I and II trials).
Created in 2005, the ETGC is composed of two production sites, authorised by the French Sanitary Safety Agency for Health Products (AFSSAPS) for a period of five years.
Our activities are performed in accordance with Standard Operating Procedures (SOP) in compliance with good manufacturing practices (GMP).
The goal of the ETGC department is to produce therapeutical batches to meet Genethon’s needs, but, depending on our availability, we also work with external laboratories, either French or from foreign countries.
Our technical expertise allows us to develop and follow-up clinical as well as phase I projects, including the creation of regulatory dossiers.
Our activities include the manufacturing of raw materials needed to produce batches of vectors (cell banks, plasmids).
The manufacturing processes of vectors consist of four phases that occur over a total period of 3 to 5 weeks:
Genethon has 2 production sites; a BL2 and a BL3 authorized sites, totaling 470 m2 of white rooms.
Due to Genethon’s projects of therapeutic trials, the ETGC is now specialized in the production of viral vectors such as adeno-associated (rAAV) or lentivirus such as human immunodeficiency virus (rHIV).
More information :
Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSaPS)
www.afssaps.fr
European Directorate for the Quality of Medicines (EDQM)
www.pheur.or
ETGC Glossary
(3 pages, 77 ko)