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

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