Eurofins BioPharma Product Testing France
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Contact
12 Rue du Parcs d'Activités
69210 Lentilly
France
Directeur Commercial et Marketing
About us
Eurofins BioPharma Product Testing France, leader in testing and analysis services for the pharmaceutical and biotechnology industries, offers a complete range of quality control, analytical development and research services in the pharmaceutical products sector. With in-depth expertise and high-performance facilities, the company helps customers to guarantee the safety, quality and regulatory compliance of their products, contributing to the advancement of health and medical research.
In France, the Eurofins BioPharma Product Testing network has 450 employees working in 6 laboratories organised around 3 main campuses in Les Ulis, Fontenilles and Lentilly and 3 specialist laboratories in Saint-Augustin, Sainte-Croix-en-Plaine and Peyruis.
Business offer
With over 20 years' experience, Eurofins offers personalised support and solutions tailored to the needs of its customers. Its comprehensive range of testing and analysis services supports pharmaceutical companies in all phases of their product life cycle. Its laboratories are equipped with state-of-the-art technology, enabling them to deliver accurate and reliable results within a short timeframe. Their areas of expertise include
- Physico-chemical analyses
- Microbiological analyses
- Development, validation and transfer of analytical methods
- Cleaning and disinfectant validation
- Root Cause Investigation - Troubleshooting
- Packaging items
- Analysis of extractables and releargables
- Nitrosamines, elemental impurities according to ICHQ3D
- Medical devices
- Stability studies, storage and clinical logistics
Activities
- Service
- Immunotherapy lead generation
- Biophysical profile
- Manufacturability
- Production quality
- CMC feasibility
- CMC
- GLP compliance
- Master Cell Bank
- Storage
- Analytical development
- Cell Culture
- Media composition
- Bioreactor conditions
- Quality assurance, quality control & analytical process
- Stability Assessment
- Physical & chemical profile
- Shear/shaking
- Viscosity
- Photostability
- pH
- Freeze/thaw
- Heat/degradation
- Aggregation
- Biosafety & Bioanalysis
- Toxicology
- 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
- Formulation
- Formulation
- Stability
- Storage stability
- Delivery
- Route of Administration
- Devices associated
- CMC/analytical quality assessment, quality control
- Cross contamination
- Sterility
- Contaminants detection
- Bioproduction engineering
- Purification/Extraction
- Filtration / microfiltration / ultrafiltration
- Centrifugation
- Chromatography
- CGMP
- Conditioning
- Storage
- Delivery
- Supply chain logistics
- Tracking process
- Monitoring logistics
- Bioproduction/CMC/Analytical Quality Assessment, Quality Control
- Supply chain logistics
- Tracking process
- Monitoring logistics
- GMP batch
- CGMP
- Cross contamination
- Sterility
- Quality control
- Contaminants detection
- Antigen-protective immune-response profile
- Humoral response characterization:
- Antibody dosage
- Functional antibody assays (neutralization, CDC, ADCC)
- Vaccine: antigen format platforms
- Recombinant protein expression
- Bacterial
- Cell
- Fungi
- mRNA vaccine
- CMC
- GMP compliance
- Master Banks (cell and viral as needed)
- storage
- shipment
- Cell Culture / Fermentation
- media formulation and supply
- Ability to work in BSL2 conditions
- Bioproduction GMP
- Pilot Batches scale
- Process development & optimization
- Scale-Up & Validation
- USP (Scale-Up)
- Vaccine shipment and distribution
- Storage matter
- Quality control & analytical process monitoring
- Stability Assessment
- Batch release test
- Chemical, physical, biological testing
- Potency assay
- Impurities detection
- Quality control test support
