BIOPHACT
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Avenue du lac / rue Pétrarque
31320 / 75016 Vigoulet Auzil / Paris
France
CEO
About us
Biophact is an independent company committed to support and assist Biotech or Pharma to transform a scientific conception into a pragmatic and feasible drug development plan compliant with the regulatory requirements and the medical need. 35 years of drug development in Big Pharmas provide a clear asset for project building.
Business offer
Using efficacy proven methodology and skills, Biophact makes your project credible and well designed for VC or competent authorities. We can help Biotech or Pharma with due diligence either for in- or for out-licensing.
Activities
- Service
- Oncology
- Nervous Central System
- Hematology
- Immunology
- Inflammation
- Target selection & validation
- Gene / protein discovery
- 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
- In-vivo models
- In-vitro & ex-vivo models
- Indication searching
- 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
- Avidity testing
- Cell-based activation (APCs, AAPCs)
- Bead-base activation
- Antibody-based activation
- Ex-vivo activation (cell transfer)
- In-vivo activation (in human transgenic mouse models)
- Gene modification / Transduction
- Retroviral & lentiviral vectors
- Transposon/transposase
- mRNA electroporation
- CRISPR/Cas9
- Immunotherapy lead optimization
- Engineering
- ADC
- Linkers
- Payloads
- Protein scaffolds
- Fragments
- Multi-, bispecific
- Fc-fusion proteins
- Indication Prioritization
- Antibody humanization
- Affinity maturation
- Proof of concept
- Pharmacology potency
- Exploratory toxicology
- in-vitro & ex-vivo models
- in-vivo models
- Cell expansion
- Gas permeable bags
- G-Rex bioreactors
- Wave-mixed bioreactors
- 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
- 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
- Cell origin
- Single donor
- Pool of donors
- Cell Banking
- IPs
- MSC
- CD34 + HSC cells
- Tissue acquisition
- Off the shelf
- Apheresis
- Target cell isolation
- iPS reprogramming
- Differentiated Cell
- Production Cell
- Safety donor-derived therapies
- 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
- Deviations
- Contaminants detection
- Safety for gene-edited cells
- translocation
- anti-nuclease response
- cytokine-independent growth
- 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
- 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
- Ex Vivo & In Vivo Strategy
- Ex Vivo & In Vivo Strategy