GenoSafe
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Contact
1 rue de l'Internationale
91000 Evry-Courcouronnes
France
Head of Business Development
About us
GenoSafe provides analytical testing services for the evaluation of quality, safety and efficacy of Biologics and Innovative Therapeutics including:
- - biodistribution, shedding and immunogenicity studies on preclinical samples;
- - QC testing and in vitro potency/efficacy testing;
- - clinical bioanalysis of patient samples, including immunogenicity, shedding and gene expression studies.
GenoSafe brings more than 20 years of experience in the development, qualification and validation of key analytical methods for product and sample testing.
Business offer
Activities
- Service
- Cardiology
- Genetic Diseases
- Oncology
- Nervous Central System
- Hematology
- Infectiology
- Immunology
- Ophthalmology
- Inflammation
- Preclinical biomarkers
- Mechanism/Function
- Mechanism of action
- Safety
- PK/PD features
- Indication Identification
- Exploratory toxicology
- Drug-Target interaction
- Level of response duration
- Specificity
- Surrogate markers
- Predictive biomarkers
- Treatment efficacy
- Population stratification
- Risk/benefit profile
- Disease progression / follow-up
- CMC
- GLP compliance
- GLP compliance
- Master Cell Bank
- Production
- Cell Line development
- Clone selection
- Characterization
- Storage
- Analytical development
- Cell Culture
- Media composition
- Bioreactor conditions
- Gene modification / Transduction
- Retroviral & lentiviral vectors
- Cell expansion
- Wave-mixed bioreactors
- Stirred tank reactors
- Quality assurance, quality control & analytical process
- Cell line analytical development
- Host cell proteins
- Viral clearance
- Contaminants detection
- Biosafety & Bioanalysis
- Toxicology
- Non-clinical safety and toxicology studies
- PK/PD features
- Impurities detection
- Bioproduction analytical test
- Monitoring
- Characterization
- Batch consistency
- Batch release test
- Chemical, physical, biological test
- Quality control test support
- Post-production test
- Real-time stability test
- Clinical trials
- Phase I
- Phase II
- Phase III
- Phase IV
- Clinical biomarkers
- Predictive biomarkers
- Treatment efficacy
- Population stratification
- Risk/benefit profile
- Disease progression / follow-up
- Safety
- PK/PD features
- Surrogate markers
- Disease progression monitoring
- Companion biomarkers
- Pharmacology
- Treatment efficacy
- Treatment monitoring
- Toxicity
- CMC/analytical quality assessment, quality control
- Contaminants detection
- Safety for gene-edited cells
- translocation
- anti-nuclease response
- cytokine-independent growth
- Non-clinical safety and toxicology studies
- Gene Delivery System
- Lentivirus
- Other Retrovirus
- Adeno-Associated Virus (AAV)
- Adenovirus (ADV)
- Bioproduction/CMC/Analytical Quality Assessment, Quality Control
- Quality control
- Contaminants detection
- Safety for gene-edited cells
- Translocation
- anti-nuclease response
- cytokine-independent growth
- Non-clinical safety and toxicology studies
- Antigen-protective immune-response profile
- Humoral response characterization:
- Antibody dosage
- Functional antibody assays (neutralization, CDC, ADCC)
- Other serological assays
- Cell mediated immunity response
- T cell assays
- CMC
- GLP compliance
- for preclinical NCS (non-clinical safety) studies
- viral safety testing
- GMP compliance
- Master Banks (cell and viral as needed)
- manufacturing
- Characterization and testing
- storage
- shipment
- Regulatory safety
- Regulatory safety tests
- Immunotoxicology
- Non-clinical safety and toxicology studies
- Clinical trials
- Phase I
- Phase II (human challenge trials)
- Phase III (large population pending pathogen prevalence)
- Immune monitoring
- Quality control & analytical process monitoring
- Stability Assessment
- Biosafety & Bioanalysis
- Toxicology
- Immune response characterization
- Viral safety
- Batch release test
- Chemical, physical, biological testing
- Potency assay
- Impurities detection
- Quality control test support
