GenoSafe is a contract research organization (CRO) specializing in the evaluation of the quality, safety, and efficacy of biological therapeutic products, particularly in the realm of advanced therapy medicinal products. The company offers a comprehensive suite of services that spans from discovery research to clinical development, including preclinical quality control, analytical development, and regulatory affairs. Their expertise encompasses a variety of innovative therapies, such as gene and cell therapies, with a strong emphasis on conducting studies in compliance with Good Laboratory Practices (GLP). GenoSafe's preclinical development services are designed to align with international guidelines, ensuring that studies are meticulously crafted to meet regulatory expectations while providing critical data on the toxicity and efficacy of drug candidates.

In addition to their preclinical services, GenoSafe focuses on immunology and molecular biology, offering custom assays to evaluate immune responses in both animal models and clinical trial participants. Their capabilities include measuring cytokines, chemokines, and growth factors, as well as assessing antibody production and neutralizing factors that may impact gene therapy outcomes. The company employs advanced techniques such as Enzyme-Linked Immunosorbent Assays (ELISA) and multiplex bead array assays to deliver precise and rapid results. Furthermore, GenoSafe is equipped to monitor immune responses to adeno-associated viral (AAV) vectors, which are commonly used in gene therapy, ensuring a thorough evaluation of both humoral and cellular immune responses to enhance the safety and efficacy of therapeutic interventions.

France

GenoSafe is a CRO providing analytical testing services for the evaluation of quality, safety and efficacy of Gene and Cell therapy candidates including :
   - GLP biodistribution, shedding and immunogenicity studies ;
   - QC testing, such as viral titration, safety and potency/efficacy testing ;
   - GCP bioanalysis of patient samples, including immunogenicity, shedding and gene expression studies.

GenoSafe brings more than 15 years of experience in the development, qualification and validation of key analytical methods for product and sample testing.

GenoSafe

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