Alter Ego biotech
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Contact
762 rue du docteur Maurer
78630 Orgeval
France
CEO
About us
We are independant CMC consultants, specialized in Biomanufacturing, providing strategic & operational support to biotech companies.
At early stage:
- You need to anticipate the CMC requirements supporting IND/IMPD
- You plan to scale-up & transfer your process to a CDMO while preserving product representativity
- Your team must integrate the GMP culture to support the development of your product
At late stage :
- You plan to modify your process for industrial performance or compliance constraints
- You need to transfer your process to a new production unit
- You need to define a CMC strategy based on a robust Quality by Design approach
In both cases, we define the appropriate supportive studies adapted to regulatory requirements.
Business offer
We provide support during the whole product life cycle with different interventions :
- CMC & Biomanufacturing lead
- One-off expertise (CDMO selection, audit, due diligence, technological evaluation, troubleshooting...)
Activities
- Service
- Cardiology
- Genetic Diseases
- Oncology
- Nervous Central System
- Hematology
- Infectiology
- Immunology
- Ophthalmology
- Inflammation
- Other
- CMC
- GLP compliance
- Master Cell Bank
- Production
- Cell Line development
- Clone selection
- Characterization
- Storage
- Analytical development
- Cell Culture
- Media composition
- Bioreactor conditions
- Cell expansion
- Wave-mixed bioreactors
- Stirred tank reactors
- Bioproduction
- Batches production type
- Mammalian
- Insect
- Yeast
- Bacterial
- 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
- 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
- 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 trials
- Phase I
- Phase II
- Phase III
- Phase IV
- CMC/analytical quality assessment, quality control
- Cleaning
- Cross contamination
- Sterility
- Deviations
- Contaminants detection
- 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
- Bioproduction/CMC/Analytical Quality Assessment, Quality Control
- Bioproduction
- Scale-Up
- Automated manufacturing
- Automated high throughput microbioreactor system
- Non-GMP pilot batch
- GMP batch
- Cleaning
- CGMP
- Cross contamination
- Sterility
- Deviations
- Quality control
- Contaminants detection
- Vaccine: antigen format platforms
- 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
- CMC
- 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
- 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
- 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
