GTP Bioways CDMO

Exhibitor

GTP Bioways is a CDMO offering expert services for process development and non- cGMP or cGMP manufacturing of antibodies and proteins using both mammalian and microbial expression systems. Founded in 2000, the company has gathered over 24 years’ experience in developing custom processes for even the most challenging proteins and mAbs.

GTP’s services for biologics include:

  • R&D services
    • Developability and manufacturability assessment
    • Batches manufacturing for efficacy or non-GLP toxicology studies
  • Cell line and strain development
  • Process development
    • USP development
    • DSP development
    • Analytical methods development
    • Custom ELISA development for HCPs detection and quantification
    • Pre-formulation, formulation and stability assessment
    • Manufacturing of pre-clinical non-GMP batches
  • DS manufacturing
    • MCB/WCB manufacturing
    • GMP batch manufacturing
    • Stability studies
    • Analytical methods validation
  • DP manufacturing
    • F&F of vials and pre-filled syringes (batches up to 10 000 units)
    • Stability studies
    • Analytical methods validation
  • Regulatory support


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