Eurofins CDMO
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Contact
2 bis avenue de Gascogne
31470 Fontenilles
France
Business Development Manager
About us
Eurofins CDMO provides integrated, end-to-end drug development solutions supporting clients from gene development through finished product.
We offer a full suite of drug development services encompassing development of the bioprocesses for a broad range of products, formulation screening, analytical development, pre-clinical testing, sterile and non-sterile bio-manufacturing of clinical trial batches, small commercial batches and orphan drugs. The group delivers solutions for the development and biomanufacturing of antibodies, proteins, enzymes, vaccines and different types of bacteria.
Business offer
✔ Accelerate pre-clinical and clinical phases of your product with easy scale-up and smooth transfer from development to GMP facilities, including fill & finish suites (manufacturing under isolator and single-use material).
✔ Produce cell banks, including research, master, working and end-of-production cell banks.
✔ Develop innovative formulations for liquid and solid dosage forms for proteins, oligonucleotides, peptides or microorganisms for various delivery routes.
✔ Develop and validate stability indicating methods, as well as stability evaluation of drug substances and developed drug products, including Accelerated Stability, ICH stability, In-Use Stability, and Accelerated Stability Assessment Programs (ASAPs).
✔ Produce batches for preclinical and early phase clinical studies.
✔ Manufacturing small batches and orphan drugs.
✔ Offer regulatory support throughout the complete development pathway.
Activities
- Service
- Cardiology
- Genetic Diseases
- Oncology
- Nervous Central System
- Hematology
- Infectiology
- Immunology
- Ophthalmology
- Inflammation
- Other
- CMC
- Master Cell Bank
- Cell Line development
- Clone selection
- Characterization
- Analytical development
- Cell Culture
- Media composition
- Bioreactor conditions
- Gene modification / Transduction
- Retroviral & lentiviral vectors
- Cell expansion
- Stirred tank reactors
- Bioproduction
- Batches production type
- Mammalian
- Yeast
- Bacterial
- GLP compliance
- GMP compliance
- Pilot Batches
- Tests
- Optimization
- Scale-Up process
- Process optimization & validation
- Volume
- Preclinical / Tox
- Low volume (< 200 L)
- USP (Scale-Up)
- Cell expansion
- Inoculation
- Low volume containers to Bioreactors
- DSP (Recovery)
- Harvest
- Filtration
- Purification
- Fill & Finish
- Aseptic filling
- Lyophilization
- Batch release
- Storage matter
- Instruction
- Logistic
- Cell cryopreservation
- Controlled-rated freezer
- thaw
- Quality assurance, quality control & analytical process
- Stability Assessment
- Physical & chemical profile
- Shear/shaking
- Viscosity
- Photostability
- pH
- Freeze/thaw
- Heat/degradation
- Aggregation
- Cell line analytical development
- Host cell proteins
- Viral clearance
- Contaminants detection
- 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
- Dose
- Stability
- Excipients
- Adjuvants
- Sterilization
- Lyophilization
- Storage stability
- Delivery
- Route of Administration
- Devices associated
- Clinical trials
- Phase I
- Phase II
- Phase III
- Vaccine: antigen format platforms
- Recombinant protein expression
- Bacterial
- Cell
- Synthetic Peptides or oligomers
- Virus-like particles (VLP) and nanoparticle-based carriers
- Killed/inactivated virus
- Live attenuated virus
- Viral vector encoding target antigen
- DNA plasmid vaccine
- mRNA vaccine
- Lipid delivery vehicle
- 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
- Cell Culture / Fermentation
- media formulation and supply
- Bioreactor conditions (cell in suspension, adherent cell player)
- Ability to work in BSL2 conditions
- Cell expansion
- Single use technology (SUS)
- Wave-mixed bioreactors
- Stirred tank reactors
- Gene modification / Transduction
- Molecular biology
- Expression systems
- Formulation
- Formulation
- Adjuvants
- Stabilization
- Excipients
- Vaccines Combination
- Lyophilization
- Shipment Monitoring
- Vaccine delivery/Administration routes
- Route of Administration
- Intramuscular route
- intradermal route
- Nasal route
- Mucosal routes
- Other devices: specify
- Delivery/ Encapsulation
- Polymeric Nanoparticles
- Lipid Nanoparticles
- Nano emulsions
- Adjuvanted delivery systems
- Clinical trials
- Phase I
- Phase II (human challenge trials)
- Phase III (large population pending pathogen prevalence)
- Bioproduction GMP
- Vaccine platform type
- Recombinant protein expression
- Synthetic Peptides or oligomers
- Virus-like particles (VLP) and nanoparticle-based carriers
- killed/inactivated virus
- Live attenuated virus
- Viral vector encoding target antigen
- DNA plasmid vaccine
- mRNA vaccine
- Lipid delivery vehicle
- Pilot Batches scale
- Process development & optimization
- Scale-Up & Validation
- Comparability characterization protocol
- Manufacturing Volume
- Small volume (< 100 L) adjusted to phase I/II needs: specify volume
- USP (Scale-Up)
- DSP (Recovery)
- Fill & finish
- Lyophilization
- Prefilled syringe
- Vaccine shipment and distribution
- Storage matter
- Labelling
- Packaging for shipping
- Instruction Label
- Cold chain logistics
- Quality control & analytical process monitoring
- Stability Assessment
- Batch release test
- Chemical, physical, biological testing
- Potency assay
- Impurities detection
- Quality control test support
