GenoSafe is a specialised analytical CRO headquartered in Évry-Courcouronnes, France, focused on the evaluation, characterisation and quality control of advanced therapy medicinal products (ATMPs). Founded in 2003 by Genethon and AFM-Téléthon, the company was established to support the growing field of gene and cell therapy from early research through to clinical and commercial development.

The company provides analytical testing services across the full pharmaceutical development lifecycle, supporting biotechnology and pharmaceutical companies developing gene therapies, cell therapies, innovative vaccines and DNA/RNA-based therapeutics. GenoSafe operates according to international regulatory standards including GLP, GMP and GCP frameworks, enabling support for both preclinical and clinical programmes.

GenoSafe’s expertise is centred around molecular biology, immunology, vectorology and bioanalysis, with services spanning biodistribution studies, immunogenicity testing, viral safety and potency assays. The company has contributed to nearly 90 clinical trials and supports customers globally, with a significant proportion of its business generated internationally, particularly in the United States.

The company operates advanced laboratory infrastructure within the Genopole biotechnology cluster in France. In 2025, GenoSafe expanded its capabilities through the opening of new GMP-compliant laboratories to support increasing demand for analytical services in advanced therapies and biopharmaceutical development.

Key products and services

Preclinical development services

• GLP biodistribution studies
• Shedding and immunogenicity testing
• Toxicology support and preclinical bioanalysis
• Analytical method development and validation

Quality control and release testing

• Viral titration and potency testing
• Safety and efficacy testing for ATMPs
• GMP analytical testing and product characterisation
• Batch release and stability testing

Clinical bioanalysis services

• GCP analysis of patient samples
• Gene expression and immunogenicity studies
• Clinical biomarker and shedding analysis
• Clinical assay qualification and validation

Gene and cell therapy expertise

• Analytical support for gene therapies
• Cell therapy characterisation and testing
• DNA/RNA therapeutic evaluation
• Innovative vaccine analysis

Regulatory and analytical support

• GLP, GMP and GCP-compliant workflows
• Analytical validation for regulatory submissions
• Support from research through market authorisation
• Tailored analytical strategies for advanced therapies

By combining expertise in molecular biology, immunology and regulatory bioanalysis, GenoSafe supports pharmaceutical and biotechnology companies developing advanced therapies and next-generation biologics. Its specialised focus on gene and cell therapies, together with its GMP-compliant analytical infrastructure and international client base, positions the company as a leading analytical CRO partner in the advanced therapeutics sector.