The planned University Hospital Institute (the "European Center for Transplantation Sciences and Immunotherapy", TSI-IHU) is now underpinned by the commissioning of new biomanufacturing capacities. On November 15th, 2010, Atlantic Bio GMP (ABG) inaugurated its 1300 m² facility dedicated to the production of gene transfer vectors for Phase I and II clinical trials.
The facility (located in Saint-Herblain, near Nantes) is the first of its kind in Europe and will significantly boost TSI-IHU's research capabilities. TSI-IHU intends to develop ground-breaking new treatments for immune rejection, novel strategies for immune tolerance (anti-CD28 therapies) and the use of stem cells and gene therapy for immunointervention or the treatment of genetic diseases.
Strong commitment from all the partners (the EFS, Nantes Metropole, Pays de la Loire Regional Council, Loire Atlantique County Council and the ERDF) has enabled the new €5.2 million production facility to be built on land owned by Nantes University Hospital. The ABG's running costs will be funded by an annual €1.5 million grant from the EFS, the AFM, INSERM and Nantes University Hospital - the four partners behind the creation of the ABG in early 2009.
"This facility reinforces the planned IHU's legitimacy in the biotherapy area because it slots perfectly into a coherent framework for the preclinical and clinical development of gene therapy.
ABG will further boost the competitiveness of our world-class research groups in this field, such as those led by Dr Philippe Moullier (Director of the Nantes Gene Therapy Unit (INSERM unit 649) and Scientific Director of the Généthon lab in 2 Evry), Dr Nicolas Ferry (Director of INSERM unit EE0502), Dr Yan Cherel (Director of a joint INRA-ENVN Development and Pathology of Muscle Tissue Laboratory) and Dr Ignacio Anegon (Director of INSERM unit 643)", emphasized Professor Jean-Paul Soulillou, who is championing the Nantes IHU project. "Within the IHU, we'll have research on viral vectors, their evaluation in large animal models of human disease, the production of viral vectors for clinical use and the University Hospital's Clinical Investigation Centre. This intermeshing of skills with high quality research is a unique opportunity for the development of biotherapies."
By using cutting-edge technologies in a highly controlled environment, all the ABG's products are manufactured according to quality and safety standards applicable to medicines for administration in humans. The facility is able to produce vectors derived from serotype 4, 5 and 8 adeno-associated viruses (AAVs) and adenovirus itself. These vectors are then modified and can transport "gene drugs" in the patient's cells, in order to restore normal cell function. There is no lack of projects underway; for example, the UMR 649 unit (led by Dr Fabienne Rolling and Dr Philippe Moullier) is producing AAV4 vectors for introducing a functional RPE65 gene into the cells of patients carrying the genetic mutation for Leber's congenital amaurosis (a condition which inevitably leads to blindness in the absence of treatment).
"The ABG is one of the first public-sector viral vector production facilities in Europe", commented Philippe Moullier MD (Scientific Director of the Généthon lab in Evry, Director of INSERM unit 649 (part of the IHU project) and Scientific Director for gene therapy projects at the ABG. "There is a very real need to progress biotherapies and this facility is unique asset for making the future Nantes-based IHU a centre of excellence in gene engineering", he added.
The AFM has been funding gene and cell therapy research labs and technical facilities in Nantes since 1996. In all, the charity has committed over €20 million in the city in the last 15 years. Thanks to this long-standing commitment to Nantes-based research groups and the drive to accelerate the development of biotherapies, the AFM is a founding partner in the Nantes IHU project. It has a seat on the board and envisions the creation (with its local partners) of a biotherapy institute in Nantes.
In line with the trend towards the concentration of gene therapy and cell transplantation resources within the planned Nantes IHU, the biopharmaceutical company LFB is thinking about establishing a production laboratory on the same site in the mid-term.