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Fujifilm Diosynth Biotechnologies

Biopharmaceutical Process Development and Manufacturing Services

Process Validation

Fujifilm Diosynth Biotechnologies

We offer process validation as an integral part of manufacturing as we know it is the key to your programme's success.

Process validation includes:

  • Determination of key process parameters and their operating ranges appropriate for the facilities on which the process will be run
  • Scale-down modeling of limits of re-use (for example, columns) and other formal frameworks to assess risk and aid good scientific judgment
  • Extractables studies
  • Good documentation to trace back and support developed rationales

process validation

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