GenoSafe SAS (GenoS)
Workpackage (WP) participation
GenoSafe is a Contract Research Organisation specialised in the evaluation of quality, safety and efficacy of bio-therapeutic products, and more specifically gene-based therapeutic products. From the research stages to clinical phases, the company carries out studies to meet client-specific needs in strict compliance with regulatory requirements. GenoSafe offers a true partnership in study design, assay development and validation, product testing and data analysis in four main fields: (i) pre-clinical developement, such as biodistribution studies of gene-based products in animal models, (ii) wuality vontrol testing – product characterisation for preclinical and clinical use, (iii) clinical development – follow-up of subjects and (iv) regulatory affairs consulting.
GenoSafe combines high-quality performance of studies, project management and business administration and is GLP compliant.
Main tasks attributed to the project
GenoSafe is an important partner who evaluates the study design of the animal studies as well as assay development in defining the species, route of administration, doses, number of animals, organs, tissues and / or fluids and data analysis (WP5, 6).
GenoSafe established molecular analysis, such as biodistribution studies of the PEDF transplanted cells and the Gene Therapeutic Medicinal Product (GTMP) in animal models in collaboration with partners UNIGE and UN.
Methodology for the determination of the number of copies of the vector in modified IPE and RPE cells will be developed. Quality control of the GTMP for preclinical and clinical use provides essential requirements to ensure the safety of the gene therapeutic TargetAMD approach.
GenoSafe will also participate in dissemination activities since the organisation is one of the European opinion leaders in biosafety issues.
Dr. Séverine Pouillotseverine.firstname.lastname@example.org
Dr. Séverine Pouillot, PhD, worked on the validation of transfer methods of human embryonic stem cells for the cardiomyopathy associated to Duchenne muscular Dystrophy therapy. She joined GenoSafe in 2008 and since then, has managed several FP6 projects (TNMD, Clingene, MYOAMP) and national collaborative projects (ADNA, hESCREEN, INgeCELL).