GenoSafe® is a contract research organization which specializes in evaluating the quality, safety and efficacy of innovative biological products.
GenoSafe offers analytical development, testing and quality control.
We meet our clients’ specific needs by performing custom studies in strict compliance with regulatory requirements.
As the development of your gene therapy or cell therapy product proceeds, GenoSafe will support your increasing needs for a specific assay method:
GenoSafe offers its clients an efficient and continuous approach ensuring the appropriate level of development at the right time according to regulatory guidelines.
Once a lead compound has been identified, the biopharmaceutical development is a long process including preclinical phases and clinical trials to obtain regulatory marketing approval. During this development a variety of analytical technologies are used to assess the characteristics of the product. Many of these methods must evolve into assays that will require validation for their final intended use. Validated test methods are necessary for full compliance with cGMP and GLP regulations.
We perform immunoassay in research grade study, Preclinical (GLP) studies and Clinical (GCP) studies.
We follow-up of the immune response before/after the treatment and help for the Inclusion/Exclusion of patients.
We assess the Cellular response using :
Cell phenotype (flow cytometry)
Evaluation of T‐Cell responses
We assess the Humoral response using :
Anti-drug antibody response
Detection / titration of binding antibodies (ELISA, ECLa (MSD platform))
Detection / titration of neutralizing antibodies (cell-based or not)
We advise investigator to define the parameters of the study
Develop and validate the qPCR methods
Perform the study in GLP conditions
Gene and protein expression assays (RT-qPCR, ELISA, W. Blot...)
We perform quality testing of produced batches :
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