FLASH BioSolutions
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Contact
3 Avenue Hubert Curien Centre d'Innovation Langlade
31100 Toulouse
France
BUSINESS DEVELOPMENT MANAGER
About us
An 18-year-old CDMO, discovering and producing innovative technologies for highly effective and innovative therapeutics. FTX’s knowhow is built on strong scientific inspiration, which offers efficient RNA and DNA transfer solutions for its biopharmaceutical customers.
Business offer
Manufacturing for the Discovery, Preclinical, Clinical and Commercial phases of biotech and pharmaceutical companies: -LentiCare® : Integrative lentivirus (DNA), particularly for CAR-T and CAR-NK applications -FlashRNA® : Non-integrative viral particles (RNA) enabling delivery of 1 to 10 different RNAs, for applications in vaccines (therapeutic and oncolytic), cell and gene therapies. -Customer-specific projects.
Activities
- Therapeutic Product
- Service
- 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
- 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
- CAR Construction
- Intracellular Domain
- T-cell activation/transduction
- Engineering
- Tandem CAR
- iCAR
- Ab-coupled TCR (ATCR)
- Modulation of CAR potency
- 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
- 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
- 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)
- DSP (Recovery)
- 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
