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GMP Manufacturing

GMP Manufacturing

ProBioGen holds a manufacturing authorization for GMP (Good manufacturing practice) compliant manufacturing and batch release of biotechnological drug substances and fulfills all present regulatory requirements by EMA and FDA.

Our scope of services includes:

  • Manufacturing of pre-clinical and GMP  grade material
  • Disposable bioreactor Technology, stirred tank bioreactors
    • Decreased risk of cross contamination
    • Reduced time to get facility up and running
    • Cost effective processes
    • Fed batch processes and ATF
  • Quality control 
    • Monitoring of the process by in-process controls
  • Quality assurance
    • Analytical methods for product characterization are developed and validated for release
    • Transfer of analytical methods
  • Regulatory support (for IMPD/IND and MAA/BLA)
  • We provide professional project management throughout all steps