ProBioGen GMP Manufacturing Services by ProBioGen AG

Manufacturer ProBioGen AG
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. GMP Manufacturing Services include: 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... Read more


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ProBioGen GMP Manufacturing Services

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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.


GMP Manufacturing Services include:

  • 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