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

Chemistry Manufacturing Control (CMC)
Scale-up
Tech transfer
Process Validation
Comparability
Cleaning processes
Viral decontamination
Single Use system qualification

Business offer

PROCESS INDUSTRIALIZATION :
We support our client in building and executing appropriate industrialization roadmap from lab-scale to manufacturing scale.
We identify, select, and assess relevant technologies to support Process Scale-up or Tech Transfer.

PROCESS CONTROL :
We provide methodologies required for Product (QTPP, CQA) & Process (CPP, KPP, nKPP) characterizations and related Process Control Strategy as expected by ICH Q8 and ICH Q11 related to Quality By Design (QbD).
We define optimized Process validation and Product comparability strategies to support clinical batches, tech transfer or PPQ batches

INDUSTRIAL PARTNERSHIP :
We make connections between biotech industry stakeholders by finding CDMO partner and by looking for new industrial applications of technology

CONTAMINATION CONTROL :
We address product contamination risks by designing an adapted Contamination Control Strategy (CCS), by validating cleaning processes and decontamination processes, and by qualifying single-use systems.

COMPLIANCE :
We provide customized GMP training courses to support your quality culture
We evaluate your organization maturity by leading GMP readiness or PPQ readiness assessment

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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