PreIndustrial Gene Therapy vector Consortium (PGT)
The PGT Consortium was awarded a grant from the ‘Avenir Investment’ Program in the first Call for Proposals for pre-industrial demonstrators in biotechnology.
This consortium is dedicated to the production of viral vectors, which are currently one of the major bottlenecks in the clinical development of gene therapies. Today this consortium constitutes a force for the development and production of these biomedicines which is unique in the world, and has therefore been supported within the framework of ‘Avenir investments’ for a duration of 9 years (2011-2019).
The ambition of PGT is to play a central role in the international arena in the production of gene therapy vectors which are indispensible for the large number of clinical trials currently taking place in the domain of biotherapies. The role of the consortium is to validate bioproduction procedures at a preindustrial scale, which is a prerequisite for the industrialization of manufacturing processes for gene therapy products and the emergence of a real industrial strategy for the production of gene therapy treatments.
PGT has a double objective: to accelerate the development of methods for vector production and quality control based on pharmaceutical norms and to respond to the growing demand for therapeutic vectors for clinical trials for rare diseases, which are becoming more and more frequent world-wide.
With this in mind, the action of the PGT consortium is based on applications of proof of concept: from preclinical regulatory studies to phase I/II clinical trials.
The mission of the consortium is to deliver gene therapy products for phase I/II studies principally but not exclusively to academic investigators.
The PGT project is structured in two phases: a phase (phase 1) in which equipment, installations and methods are designed and set up, followed by a functional and production phase (phase 2).
The consortium is composed of four first-class actors in the domain of gene therapy and bioproduction in France: Genethon and GenoSafe which are located in Evry, and Atlantic BIO GMP (ABG-EFS) and a UniversityHospitalCenter, both located in Nantes. Genethon is a non-profit biotherapy R&D organization created and funded by the Association Française contre les Myopathies, whereas GenoSafe is a private company. ABG is part of the French Blood Agency and the Nantes University hospital center; both are public structures under the authority of the Ministry of Health.