Texcell
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Contact
1 Rue Pierre Fontaine
91000 Evry Courcouronnes
France
Chief Business Officer
About us
From a service laboratory at the renowned Pasteur Institute in Paris in 1987 to an international contract research organization, Texcell has supported thousands of pharmaceutical and biotech companies in their journey to ensure the safety of their products, from preclinical stages to commercialization.
From our roots outside of Paris, Texcell Group has built out a growing network of technical support and laboratory facilities around the world. With an established presence in France, US, and Germany and a growing presence throughout Asia, we will support you wherever you need.
Business offer
Texcell is a contract research organization that specializes in viral testing, viral & prion clearance, bioassays, in vivo testing and GMP cell banking, for R&D, GLP and GMP projects.
Texcell offers a comprehensive catalog of tests for viral safety of products, and services to assess the ability of industrial process steps to eliminate and/or inactivate viruses (over thirty model or relevant viruses are offered) and prions.
Texcell is also a centralized laboratory for preclinical and clinical trials. It offers a technology platform dedicated to immunology, with a range of comprehensive assay developments (optimization and validation) under GMP conditions to analyze humoral and/or cell-mediated immune responses.
Activities
- Service
- Cardiology
- Genetic Diseases
- Oncology
- Nervous Central System
- Hematology
- Infectiology
- Immunology
- Ophthalmology
- Inflammation
- Target selection & validation
- Expression and pathway analysis of target
- quantification of target
- Assay development in in-vitro & in-vivo models
- Research exploratory companion biomarkers
- CMC
- GLP compliance
- GLP compliance
- Master Cell Bank
- Production
- Cell Line development
- Clone selection
- Characterization
- Storage
- Analytical development
- Bioproduction
- GLP compliance
- GMP compliance
- Quality assurance, quality control & analytical process
- Cell line analytical development
- Viral clearance
- Contaminants detection
- Biosafety & Bioanalysis
- Toxicology
- PK/PD features
- 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
- Safety
- PK/PD features
- Regulatory filing
- Regulatory Filing
- Companion biomarkers
- Treatment efficacy
- Treatment monitoring
- Toxicity
- Post-market surveillance
- Post-Market Surveillance
- Ex Vivo & In Vivo Strategy
- Ex Vivo & In Vivo Strategy
- CMC/analytical quality assessment, quality control
- Sterility
- Contaminants detection
- Bioproduction engineering
- CGMP
- Target Identification
- Assay development in in-vitro & in-vivo models
- Gene Delivery System
- Lentivirus
- Other Retrovirus
- Adeno-Associated Virus (AAV)
- Binder Generation
- Mouse immunization
- Ex Vivo & In Vivo Strategy
- Ex Vivo & In Vivo Strategy
- Bioproduction/CMC/Analytical Quality Assessment, Quality Control
- Quality control
- Contaminants detection
- Antigen identification, selection, optimization, and validation
- Assay development with in-vitro & in-vivo models
- Antigen characterization
- Antigen selection: pathogen sequencing and functional antigens
- Immunogenicity in relevant animal models
- Pathogen-host knowledge
- Pathogen genetics and mechanism of action
- In-vivo expression during pathogen cycle
- In-vitro and in-vivo models
- Antigen-protective immune-response profile
- Humoral response characterization:
- Antibody dosage
- Functional antibody assays (neutralization, CDC, ADCC)
- Other serological assays
- Vaccine: antigen format platforms
- Recombinant protein expression
- Cell
- Killed/inactivated virus
- Live attenuated virus
- Challenge test – Gold Standard
- In-vivo animal models
- Induced immune response characterization
- In-vitro models
- Ex-vivo models
- 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
- Vaccine delivery/Administration routes
- Route of Administration
- Intramuscular route
- intradermal route
- Nasal route
- Mucosal routes
- Regulatory safety
- Regulatory safety tests
- Viral safety
- Immunotoxicology
- 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
- Bioproduction analytical monitoring
- Key and critical process parameters (KCP, CPP)
- Identification
- Monitoring
- Batch release test
- Chemical, physical, biological testing
- Potency assay
- Challenge animal models
- Impurities detection
- Quality control test support
- Regulatory Filing
- Regulatory Filing
- New Drug Application (IND)
- Investigational Medicinal Product (IMPT) for clinical investigations (EMA)
- Common Technical document (CTD) section 3 (CMC) 4 (NCS) and 5 (Clinics) for submission
- Post-market surveillance
- Clinical Trial phase IV
- Immune monitoring
