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Scale Down Model Development

Highlights

  • Development of predictive scale down models based on a data science approach
  • Second opinion studies on scale down models
  • Improvment strategies of scale down models

Benefits

  • Benefit from experienced biotech- and statistics consultants
  • Decrease risk of scale up
  • Increase success rate of process characterization

Successfull commercialization of biotech products heavily depend on the quality and predictive power of the scale down models used for process development purposes. Using a well characterized and predictive scale down model reduces the during scale-up to manufacturing scale. Thereby, the risk for unwanted changes in productivity and product quality is reduced, achieving excellent scale up. Exputec supports the development of scale-down models based on its long-term experience in the scale up of biotechnological processes using the inCyght data science approach.

  • Assessment of overall scale-ability of the integrated process to avoid scaling pitfalls
  • Characterization and qualification support for upstream- and downstream scale-down models to understand the variances
  • Improvment of scale-down models based on mechanistic modelling