GenoSafe
GenoSafe is a CRO specializing in the characterization and evaluation of innovative therapeutics, supporting projects throughout research, preclinical, quality control, and clinical stages. With over 20 years of expertise, they focus on analytical methods for gene and cell therapies, vaccines, and DNA/RNA products, ensuring regulatory compliance and quality. They also provide comprehensive services in preclinical, clinical, and quality control development, with a strong emphasis on methods validated in compliance with GMP, ICH, and BPx standards. GenoSafe supports clients from early research to clinical development, offering tailored analytical solutions, method validation, and testing across various platforms, including PCR, flow cytometry, ELISA, MSD-ECLA, and more. The company is involved in standardization efforts such as the ARDAT project and maintains certifications like BPL since 2008.
Industries
Nr. of Employees
small (1-50)
Services
Laboratory development, transfer, qualification and validation of analytical methods for preclinical, quality-control and clinical applications in compliance with GxP and ICH/FDA guidelines.
End-to-end biodistribution studies including tissue extraction, nucleic acid detection/quantification and reporting, executed under appropriate quality frameworks (BPL/GLP where required).
Humoral assays (cell-based neutralization, ELISA/ECL for total antibodies/ADA) and cellular assays (ELISpot, flow cytometry) to quantify immune responses in preclinical and clinical samples; screening and confirmatory workflows supported.
Multiplexed protein biomarker panels and single-plex assays using ELISA and electrochemiluminescence platforms to quantify cytokines, chemokines and other protein biomarkers from limited sample volumes.
Analytical testing for vector and cell therapy quality attributes including physical and infectious titration, genome and capsid quantification, full/empty capsid ratio, protein composition, contaminant detection, VCN/p24 measurement, potency, identity and stability studies; methods developed and validated to meet BPF/ICH/GMP expectations where applicable.
Performance of validated or bespoke assays for clinical sample testing to monitor immunogenicity, shedding, tissue expression (biopsies) and other clinical endpoints, aligned with regulatory guidance including FDA/ICH M10.
Laboratory development, transfer, qualification and validation of analytical methods for preclinical, quality-control and clinical applications in compliance with GxP and ICH/FDA guidelines.
End-to-end biodistribution studies including tissue extraction, nucleic acid detection/quantification and reporting, executed under appropriate quality frameworks (BPL/GLP where required).
Humoral assays (cell-based neutralization, ELISA/ECL for total antibodies/ADA) and cellular assays (ELISpot, flow cytometry) to quantify immune responses in preclinical and clinical samples; screening and confirmatory workflows supported.
Multiplexed protein biomarker panels and single-plex assays using ELISA and electrochemiluminescence platforms to quantify cytokines, chemokines and other protein biomarkers from limited sample volumes.
Analytical testing for vector and cell therapy quality attributes including physical and infectious titration, genome and capsid quantification, full/empty capsid ratio, protein composition, contaminant detection, VCN/p24 measurement, potency, identity and stability studies; methods developed and validated to meet BPF/ICH/GMP expectations where applicable.
Performance of validated or bespoke assays for clinical sample testing to monitor immunogenicity, shedding, tissue expression (biopsies) and other clinical endpoints, aligned with regulatory guidance including FDA/ICH M10.
Expertise Areas
- Preclinical biodistribution and expression studies
- Immunogenicity assessment (humoral and cellular)
- ATMP quality control and lot release analytics
- Clinical bioanalysis for ATMPs
Key Technologies
- qPCR / RT-qPCR
- Digital PCR (dPCR)
- Automated nucleic acid extraction
- Flow cytometry
News & Updates
Announcement of 20 years of GenoSafe's operation.
Scientific publication on AAV vector safety and efficacy.
Method for detecting neutralizing antibodies in gene therapy.
Study on immune response to AAV vectors.
GLP certification since 2008
GenoSafe has been certified GLP by the French Agency (ANSM) since 2008.
Involved in over 40 preclinical studies
GenoSafe has contributed to more than 40 preclinical studies.
Announcement of 20 years of GenoSafe's operation.
Scientific publication on AAV vector safety and efficacy.
Method for detecting neutralizing antibodies in gene therapy.
Study on immune response to AAV vectors.
GLP certification since 2008
GenoSafe has been certified GLP by the French Agency (ANSM) since 2008.
Involved in over 40 preclinical studies
GenoSafe has contributed to more than 40 preclinical studies.