Voisin Consulting Life Sciences

Activities

Categories

• Service
• Consulting

Therapeutic applications

• Cardiology
• Genetic Diseases
• Oncology
• Nervous Central System
• Hematology
• Infectiology
• Immunology
• Ophthalmology
• Inflammation

Expertises

Directory of Antibodies, Recombinant proteins and others

• 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
• Research exploratory Companion biomarkers
• Bioinformatics design
• Bioinformatics prediction & analysis
• Animal biomarkers
• Human biomarkers
• 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
• 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
• 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 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
Cell Therapy Directory

• Cell modification
• Direct reprogramming
• Cell Activation
• Ex Vivo & In Vivo Strategy
• Ex Vivo & In Vivo Strategy
• CMC/analytical quality assessment, quality control
• Cleaning
• Cross contamination
• Sterility
• Contaminants detection
• Safety for gene-edited cells
• translocation
• anti-nuclease response
• cytokine-independent growth
• Non-clinical safety and toxicology studies
Gene and CAR-T cell therapy Directory

• 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
• Gene Cloning
• Gene augmentation
• Gene inhibition
• Killing Gene
• KI / KO
• (Gene) engineering
• CRISPR activation
• CRISPR interference
• TRAC gene editing
• TALEN
• Gene Delivery System
• Lentivirus
• Other Retrovirus
• Adeno-Associated Virus (AAV)
• Adenovirus (ADV)
• Gene Gun
• Electroporation
• Lipid chemical methods
• Protein chemical methods
• Mixed chemical methods
• Inorganic methods
• Biomarker Identification
• Research exploratory Companion biomarkers
• Bioinformatics design
• Bioinformatics prediction & analysis
• CAR Construction
• Intracellular Domain
• T-cell activation/transduction
• Engineering
• Tandem CAR
• iCAR
• Ab-coupled TCR (ATCR)
• Modulation of CAR potency
• Adoptive T Cell Major Challenges in Solid Tumors
• Tumor/Ag heterogeneity
• Tumor associated Antigen
• Microenvironment
• Delivery/homing
• Combinations
• Persistence of CAR-T
• In vivo proliferation and activation of CAR-T
• Accessibility of tumor cells
• Cell procurement
• Autologous
• 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
• Sterility
• Deviations
• Quality control
• Contaminants detection
• Safety for gene-edited cells
• Translocation
• anti-nuclease response
• cytokine-independent growth
• Non-clinical safety and toxicology studies
Prophylactic Vaccines Directory

• 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
• Bacterial
• Cell
• Fungi
• 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
• 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
• 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
• 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
• Final scale up volume (> 1000 L) and validation for manufacturing
• Commercial supply during life cycle management
• USP (Scale-Up)
• Fill & finish
• Lyophilization
• Prefilled syringe
• Vaccine shipment and distribution
• Storage matter
• Labelling
• Packaging for shipping
• Instruction Label
• 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