Process Development

We deliver the rapid progress of your biologic candidate into production. We achieve this with our extensive process development capabilities, which are robust, reproducible and scalable.

The step-wise approach taken during process development is as follows:

  • Upstream process development
  • Bioreactor evaluation of the selected clones
  • Culture conditions identification and improvement
  • Feeding regime optimization
  • Design of Experiments (DOE) and process modelling approaches at different stages of development
  • Process troubleshooting for quality, yield and robustness
  • Support for scale-up
  • Downstream process development
  • Single/multiple unit operation development and optimization
  • FMEA for CQA in a given unit operation
  • Process scale-down model and validation
  • Process characterization (statistical approach) and validation studies
  • TTD preparation and Process transfer at other manufacturing site
  • Support for process scale-up to bioreactor scale