PG Consulting
keyboard_backspaceBack to Home
Contact
12 rue Léon Hornecker
67200 Strasbourg
France
Président
About us
By providing its expertise and strategic input, PG Consulting supports Life Sciences companies in the development of their product candidates, from discovery to initiation of clinical trials (human & animal health).
Business offer
• State-of-the-art reports ;
• Research and identification of new targets, products, processes or innovation avenues ;
• Implementing CMC and non-clinical development strategy of the product candidate ;
• Project management, supervision & coordination ;
• Expertise in CMC-related activities of products under development ;
• Strategic review & evaluation ;
• Drafting of scientific & specific documents : scientific dossiers ”CIR” (French research tax credit), study reports, slide decks for oral presentations, re- search papers & review articles, answers to questions from competent authorities and review of MAA dossiers… ;
• Technical Support ;
• Implementing strategic foresight : science, technology, regulatory watch, competitive Intelligence, commercial intelligence.
Activities
- Service
- Oncology
- Infectiology
- Immunology
- Inflammation
- Other
- Target selection & validation
- Gene / protein discovery
- Assay development in in-vitro & in-vivo models
- Immunotherapy lead generation
- Biophysical profile
- Potency & Specificity
- Pharmacology & Biological activity
- Mode of Action
- Therapeutic efficacy
- Safety
- Immunogenicity
- Hypersensitivity & allergies
- Immunotoxicology
- Specificity
- Cell activation
- Cell-based activation (APCs, AAPCs)
- Bead-base activation
- Antibody-based activation
- Immunotherapy lead optimization
- Engineering
- Linkers
- Protein scaffolds
- Proof of concept
- Pharmacology potency
- Preclinical biomarkers
- Mechanism/Function
- Mechanism of action
- Indication Identification
- Drug-Target interaction
- Specificity
- Research exploratory Companion biomarkers
- Animal biomarkers
- Human biomarkers
- Predictive biomarkers
- Treatment efficacy
- CMC
- GLP compliance
- GLP compliance
- Master Cell Bank
- Cell Line development
- Characterization
- Analytical development
- Cell Culture
- Media composition
- Bioreactor conditions
- Bioproduction
- Batches production type
- Bacterial
- GLP compliance
- GMP compliance
- Pilot Batches
- Tests
- Optimization
- Scale-Up process
- Volume
- Preclinical / Tox
- Low volume (< 200 L)
- USP (Scale-Up)
- Cell expansion
- Low volume containers to Bioreactors
- DSP (Recovery)
- Harvest
- Filtration
- Purification
- Fill & Finish
- Aseptic filling
- Lyophilization
- Quality assurance, quality control & analytical process
- Stability Assessment
- Physical & chemical profile
- Viscosity
- Photostability
- pH
- Freeze/thaw
- Heat/degradation
- Aggregation
- Cell line analytical development
- Host cell proteins
- Biosafety & Bioanalysis
- PK/PD features
- Impurities detection
- Bioproduction analytical test
- Monitoring
- Characterization
- Batch consistency
- Batch release test
- Chemical, physical, biological test
- Post-production test
- Real-time stability test
- Formulation
- Formulation
- Dose
- Stability
- Excipients
- Adjuvants
- Sterilization
- Lyophilization
- Storage stability
- Delivery
- Route of Administration
- Devices associated
- Clinical biomarkers
- Predictive biomarkers
- Treatment efficacy
- Regulatory filing
- Regulatory Filing
- Antigen identification, selection, optimization, and validation
- 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
- Membrane antigens
- Internal protein
- Less immunogenic
- Conservative sequence
- Immunogenicity in relevant animal 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
- Research exploratory biomarkers
- efficiency vaccination
- protection correlation
- Vaccine: antigen format platforms
- Recombinant protein expression
- Bacterial
- Synthetic Peptides or oligomers
- Virus-like particles (VLP) and nanoparticle-based carriers
- Killed/inactivated virus
- Live attenuated virus
- DNA plasmid vaccine
- mRNA vaccine
- Lipid delivery vehicle
- Polysaccharides/ conjugated vaccines
- Other
- Challenge test – Gold Standard
- In-vivo animal models
- Induced immune response characterization
- 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
- Cell Culture / Fermentation
- media formulation and supply
- Bioreactor conditions (cell in suspension, adherent cell player)
- Cell expansion
- Single use technology (SUS)
- Formulation
- Formulation
- Adjuvants
- Stabilization
- Excipients
- Vaccines Combination
- Lyophilization
- Vaccine delivery/Administration routes
- Route of Administration
- Intramuscular route
- Nasal route
- Delivery/ Encapsulation
- Polymeric Nanoparticles
- Lipid Nanoparticles
- Nano emulsions
- Adjuvanted delivery systems
- 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
- DNA plasmid vaccine
- mRNA vaccine
- Lipid delivery vehicle
- Outer-membrane vesicles (OMV)
- Polysaccharides/ conjugated vaccines
- Pilot Batches scale
- Process development & optimization
- Scale-Up & Validation
- Manufacturing Volume
- Small volume (< 100 L) adjusted to phase I/II needs: specify volume
- USP (Scale-Up)
- DSP (Recovery)
- Fill & finish
- Lyophilization
- Prefilled syringe
- Quality control & analytical process monitoring
- Stability Assessment
- Biosafety & Bioanalysis
- Immune response characterization
- Bioproduction analytical monitoring
- Key and critical process parameters (KCP, CPP)
- Identification
- Batch release test
- Potency assay
- Impurities detection
- Regulatory Filing
- Regulatory Filing
- New Drug Application (IND)
- Common Technical document (CTD) section 3 (CMC) 4 (NCS) and 5 (Clinics) for submission
