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Contact
location_on
48 Rue Roberval
87280 Limoges
France
public
Aurelien Gaillard
Directeur BD
Directeur BD
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About us
CDMO for large molecule, small molecule , peptides and mRNA vaccine
State of the Art Filling Line Capable of Filling Vials,
Syringes, and Cartridges
Business offer
Drug substance, Drug product & Intermediates, New Biologic Entities (NBEs) & biosimilars:
DP Formulation Development, DP Process Development, DP Characterization, Impurity:Degaradation pathway, Clinical In use Compatibility Studies, DP Stability Studies, Analytical Method Development
Global Capabilities for Biologics Analytical Services
Activities
- Therapeutic Product
- Oncology
- Immunology
- Target selection & validation
- Gene / protein discovery
- bioinformatics design
- Expression and pathway analysis of target
- quantification of target
- Assay development in in-vitro & in-vivo models
- Research exploratory companion biomarkers
- Hit discovery
- Screening & Identification
- Therapeutic libraries
- In silico
- In-vivo models
- In-vitro & ex-vivo models
- Indication searching
- Bioinformatics prediction & analysis
- Immunotherapy lead generation
- Biophysical profile
- Binding & Affinity
- Potency & Specificity
- Epitope mapping
- Functional effects
- ADCC, ADCP & CDC
- Antigen density target
- Internalization
- Pharmacology & Biological activity
- PK/PD bioavailability
- Mode of Action
- Therapeutic efficacy
- Safety
- Immunogenicity
- Hypersensitivity & allergies
- Immunotoxicology
- Specificity
- Manufacturability
- Production quality
- CMC feasibility
- Cell activation
- Antibody-based activation
- Gene modification / Transduction
- mRNA electroporation
- CRISPR/Cas9
- Immunotherapy lead optimization
- Engineering
- ADC
- Linkers
- Fragments
- Fc-fusion proteins
- 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
- Bioproduction
- Batches production type
- Mammalian
- GLP compliance
- GMP compliance
- Pilot Batches
- Tests
- Optimization
- Scale-Up process
- Process optimization & validation
- Volume
- Preclinical / Tox
- Low volume (< 200 L)
- High volume (200 – 2000 L)
- Very high volume (> 2000 L)
- Commercial
- 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
- 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
- Regulatory filing
- Regulatory Filing
- Companion biomarkers
- Pharmacology
- 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
- Cleaning
- Cross contamination
- Sterility
- Deviations
- Contaminants detection
- Safety for gene-edited cells
- translocation
- anti-nuclease response
- cytokine-independent growth
- Bioproduction engineering
- Cell Expansion
- Stirred tank Bioreactor
- Wave bioreactor
- Cell factory
- Microcarrier-based culture
- Organoids culture
- Capsules culture
- Scale-Up
- Process optimization
- Automated manufacturing
- On-line monitoring
- Automated high throughput microbioreactor system
- Non-GMP expansion
- GMP expansion
- Other
- Purification/Extraction
- Filtration / microfiltration / ultrafiltration
- Centrifugation
- Chromatography
- CGMP
- Bioproduction modeling
- Metabolic / Kinetic modeling
- Control / command
- Global optimization
- Economic analyses
- Artificial Intelligence tools
- Formulation
- Conditioning
- Storage
- Delivery
- Transport
- Supply chain logistics
- Tracking process
- Monitoring logistics
- Target Identification
- Gene / protein discovery
- bioinformatics design
- Expression and pathway analysis of target
- quantification of target
- Assay development in in-vitro & in-vivo models
- Research exploratory companion biomarkers
- Biomarker Identification
- Research exploratory Companion biomarkers
- Bioinformatics design
- Bioinformatics prediction & analysis
- Binder Generation
- Mouse immunization
- Phage Display
- In silico
- Hybridoma
- CAR Construction
- Intracellular Domain
- T-cell activation/transduction
- Engineering
- Tandem CAR
- iCAR
- Ab-coupled TCR (ATCR)
- Modulation of CAR potency
- Ex Vivo & In Vivo Strategy
- Ex Vivo & In Vivo Strategy
- Bioproduction/CMC/Analytical Quality Assessment, Quality Control
- Bioproduction
- Scale-Up
- Automated manufacturing
- Automated high throughput microbioreactor system
- Supply chain logistics
- Tracking process
- Monitoring logistics
- Non-GMP pilot batch
- GMP batch
- Cleaning
- CGMP
- Cross contamination
- Sterility
- Deviations
- Quality control
- Contaminants detection
- Safety for gene-edited cells
- Translocation
- anti-nuclease response
- cytokine-independent growth
- Antigen identification, selection, optimization, and validation
- Omics analysis
- In silico modeling
- Structure-based antigen design
- Reverse vaccinology
- Epidemiology analysis
- Antigen expression systems
- Assay development with in-vitro & in-vivo models
- Antigen characterization
- Antigen optimization:
- Generation of mutants
- Early purification
- Early formulation
- Antigen selection: pathogen sequencing and functional antigens
- Surface glycoproteins
- Strongly immunogenic
- Mutation variability
- Membrane antigens
- Outer-membrane proteins (OMP), toxins
- Internal protein
- Less immunogenic
- Conservative sequence
- Immunogenicity in relevant animal models
- Pathogen-host knowledge
- Pathogen genetics and mechanism of action
- Biomolecular analysis
- In-vivo expression during pathogen cycle
- Host interaction (infection mechanisms)
- 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
- Cell mediated immunity response
- T cell assays
- Reactogenicity Assessment
- Research exploratory biomarkers
- efficiency vaccination
- protection correlation
- Vaccine: antigen format platforms
- Recombinant protein expression
- Cell
- Synthetic Peptides or oligomers
- Virus-like particles (VLP) and nanoparticle-based carriers
- Killed/inactivated virus
- DNA plasmid vaccine
- mRNA vaccine
- Polysaccharides/ conjugated vaccines
- 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
- 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
- Regulatory safety
- Specificity
- Human sequence homologies
- Regulatory safety tests
- Viral safety
- Hypersensitivity
- Immunotoxicology
- Clinical trials
- Phase I
- Phase II (human challenge trials)
- Phase III (large population pending pathogen prevalence)
- Immune monitoring
- Data management
- 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
- Outer-membrane vesicles (OMV)
- Polysaccharides/ conjugated vaccines
- Other
- 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
- Large volume (100 – 1000 L) adapted for phase III needs
- USP (Scale-Up)
- DSP (Recovery)
- Fill & finish
- Lyophilization
- Prefilled syringe
- Vaccine shipment and distribution
- Storage matter
- Labelling
- Packaging for shipping
- Instruction Label
- Digitalization of bar code
- Cold chain logistics
- 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
Categories
Therapeutic applications
Expertises
Directory of Antibodies, Recombinant proteins and others
Cell Therapy Directory
Gene and CAR-T cell therapy Directory
Prophylactic Vaccines Directory
