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Management of all CMC activities for recombinant proteins and cell therapy

CMC – recombinant proteins

Expertise in all CMC development steps for recombinant proteins and monoclonal antibodies (mammalian cells, prokaryote cells, transgenic animal)

Documentation

Outsourced activities:

    • MCB/WCB preparation and characterization
    • QC testing and Viral testing
    • from development lab to GMP facility (drug substance and drug product)
    • from GMP facility to large scale facility (drug substance and drug product)

CMC – Cell & Gene therapy

Management of all CMC activities for cell & gene therapy

    • Raw material supply and certificate of analysis
    • Gene modification optimization
    • Amplification and scale up
    • Analytical method establishment using improved technologies
    • Optimized formulation and storage
    • Reference standard preparation and characterization
    • Tech transfer to GMP facility (drug substance and drug product)
    • GMP batch manufacturing follow up

Bring my expertise to support companies in developing innovative and dedicated therapies.