We support our clients in designing their studies in accordance with international guidelines and methods validation by developing intelligent designs for the testing that will meet the expectations of the authorities and that are designed the minimum required development for the forthcoming clinical testing. We perform the studies in full compliance with GLP regulations and provide detailed study reports to support your regulatory submission.
The primary objective of your preclinical evaluation is to assess the toxicity and efficacy for your drug candidate providing you with accurate information of what can achieve your asset.
GenoSafe has a long and unique experience for carrying out the analytical testing of biological products with a special focus on novel therapies such as gene and cell therapies.
Drug formulation evaluation
Germline transmission studies
In vivo Gene Therapy
Non integrative Lentivirus vectors
Non vectorised DNA (plasmid)
Ex vivo Gene Therapy (autologous or allogenic)
Somatic Cell therapy
Stem Cells (Differenciated)
Autologous modified cells
The characterization of a product biodistribution profile following in vivo administration is a major component of a preclinical development program.
Biodistribution studies, required by regulatory agencies, are intended to determine the potential for a vector or a cellular agent presence and persistence in targeted tissues/biological fluids and their dissemination into non-target tissues/biological fluids and in the germline.
The biodistribution data, coupled with other preclinical safety endpoints help to determine whether product presence or gene expression correlates with any tissue-specific detrimental effects in the animals.
GenoSafe offers tissue/biological fluid analysis, using a quantitative PCR (qPCR) validated assay to determine the number of vector copies per microgram of genomic DNA.
In addition, the presence of a vector sequence in tissues/biological fluids may trigger further analysis to determine the transgene expression levels using reverse transcription quantitative PCR (RT-qPCR).
GenoSafe performs biodistribution studies in full compliance with GLP guidelines.