Alter Ego biotech

MABDESIGN MEMBER

About us

As experts in bioprocess industrialization, we provide CMC strategy setting up & operational support from pre-clinical stages to product commercialization.

Know-how

CMC
scale-up
Tech transfer
Validation
Decontamination
SUS

Business offer

Process Industralization
Process control
Industrial partnership
Contamination control
GMP compliance

Field of application
  • antibodies
  • cellular immunotherapy
  • immunomodulators
  • Gene Therapy
Therapeutic application
  • cardiology
  • genetic diseases
  • hematology
  • infectiology
  • immunology
  • oncology
  • ophtalmology

Expertise

  • GMP compliance
  • Master Cell Bank
  • Production
  • Characterization
  • Storage
  • Cell Culture
  • Bioreactor conditions
  • Cell expansion
  • Wave-mixed bioreactors
  • Stirred tank reactors
  • 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
  • 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
  • Viral clearance
  • Bioproduction analytical test
  • Monitoring
  • Characterization
  • Batch consistency
  • Batch release test
  • Chemical, physical, biological test
  • Quality control test support

Category

  • Service

Contact