
ABL Europe
MABDESIGN MEMBER
About us
CDMO services for GMP viral vectors.
Know-how
Gene therapies, oncolytic viruses and vaccines
Business offer
Development: Process and Analytical, Transfer, optimisation, or full development, Process scale-up & demonstration batches
Viral vector GMP manufacturing: Drug substance and Drug product, Phase 1 – 3, commercial launch
Supporting services: QC release & stability testing, Process & analytical validation, CMC regulatory support
Field of application
- Gene therapy
Expertise
- GMP compliance
- Master Cell Bank
- Production
- Characterization
- Storage
- Analytical development
- Cell Culture
- Media composition
- Bioreactor conditions
- Gene modification / Transduction
- Retroviral & lentiviral vectors
- Cell expansion
- Wave-mixed bioreactors
- Stirred tank reactors
- Batches production type
- Mammalian
- GMP compliance
- Pilot Batches
- Tests
- Optimization
- Scale-Up process
- Process optimization & validation
- Volume
- Preclinical / Tox
- Low volume (< 200 L)
- High volume (200 – 2000 L)
- Commercial
- USP (Scale-Up)
- Cell expansion
- Inoculation
- Low volume containers to Bioreactors
- DSP (Recovery)
- Harvest
- Filtration
- Purification
- Fill & Finish
- Aseptic filling
- Batch release
- Storage matter
- Instruction
- Cell cryopreservation
- Controlled-rated freezer
- thaw
- 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
- 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
Category
- Service
Contact
- Patrick Mahieux
CEO - Headquarter
4 Rue Laurent Fries,
67400 Illkirch-Graffenstaden 67400 Strasbourg - +33 (0)4 37 28 73 00
- pmahieux@ableurope.com
- https://www.abl-biomanufacturing.com/fr/accueil/