Alter Ego biotech

MABDESIGN MEMBER

About us

Alter Ego biotech provides CMC and biomanufacturing expertise from clinical stages to licensed products.

Know-how

Chemistry Manufacturing Control (CMC)
Process Improvement: Technology assessment, scale-up, ...)
Tech transfer to GMP environment
Quality by Design
Process Validation
Comparability
Cleaning validation
Viral decontamination
Single Use system qualification

Business offer

We operate as :

CMC lead
By your side, we are part of your team to manage CMC & and particularly GMP biomanufacturing topics. We bring an operational perspective on CMC strategy establishment and coordination from CDMO selection or implementation of GMP manufacturing facilities to process validation and regulatory submission.

Operational Project manager
We lead your projects by providing technical expertise combined with customized methodologies and tailored CMC packages

Expert for ad-hoc requests
Due Diligence, Technological assessment, Troubleshooting, Audit

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

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