AM-Biotech Consulting
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Contact
5 Avenue de Champagne
91940 LES ULIS
France
Présidente
About us
After working several years in different companies (start-up, biotech and big pharma) as CMC expert in recombinant protein and cell therapy, I decided to become consultant in order to help small companies (start-up, R&D, CDMO, Biotech) to develop dedicated innovative therapies by sharing my expertise in CMC such as process optimization, tech transfer and bioproduction (non-GMP and GMP).
Business offer
- - Management of complex project : optimization, industrialization, Tech transfer, non GMP and GMP activities (Drug Substance and Drug Product)
- - Selection of strategic CDMO for development and production.
- - Management of CAR-T cells project (optimization, Tech transfer, clinical batch manufacturing)
- - Senior expertise in project management (planning, budget, organization…), time and cost saving
- - Transition GMP manufacturing manager in small company (management of API, Aseptic filling, supply chain and maintenance teams): reorganization, planification of GMP activities, solving technical issue.
- - Regulatory dossier: technical support for writing
- New project evaluation and recommendation (Due Diligence)
- - E-learning Biotech (recombinant protein & cell therapy) training preparation.
- - Trainer in Biotechnology
Activities
- Service
- Oncology
- Hematology
- Immunology
- Inflammation
- Immunotherapy lead generation
- Manufacturability
- Production quality
- CMC feasibility
- Immunotherapy lead optimization
- Cell expansion
- G-Rex bioreactors
- 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
- Bioproduction
- Batches production type
- Mammalian
- Bacterial
- GLP compliance
- GMP compliance
- Pilot Batches
- Tests
- Optimization
- Scale-Up process
- Process optimization & validation
- Volume
- Preclinical / Tox
- Low volume (< 200 L)
- High volume (200 – 2000 L)
- USP (Scale-Up)
- Cell expansion
- Inoculation
- Low volume containers to Bioreactors
- DSP (Recovery)
- Harvest
- Filtration
- Purification
- Fill & Finish
- Aseptic filling
- Lyophilization
- Batch release
- Storage matter
- Instruction
- Logistic
- Cell cryopreservation
- Controlled-rated freezer
- thaw
- Quality assurance, quality control & analytical process
- Bioproduction analytical test
- Monitoring
- Characterization
- Batch consistency
- Formulation
- Formulation
- Stability
- Excipients
- Adjuvants
- Sterilization
- Lyophilization
- Storage stability
- Delivery
- Route of Administration
- Cell origin
- Single donor
- CMC/analytical quality assessment, quality control
- Cleaning
- Sterility
- Deviations
- Safety for gene-edited cells
- translocation
- anti-nuclease response
- cytokine-independent growth
- Bioproduction engineering
- Cell Expansion
- Stirred tank Bioreactor
- Wave bioreactor
- Cell factory
- Scale-Up
- Process optimization
- Automated manufacturing
- On-line monitoring
- Non-GMP expansion
- GMP expansion
- Purification/Extraction
- Chromatography
- CGMP
- Bioproduction modeling
- Global optimization
- Economic analyses
- Formulation
- Conditioning
- Storage
- Gene Delivery System
- Lentivirus
- Electroporation
- CAR Construction
- Engineering
- Modulation of CAR potency
- Bioproduction/CMC/Analytical Quality Assessment, Quality Control
- Bioproduction
- Scale-Up
- Tracking process
- 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
