Process Development

We deliver the rapid progress of your biologic candidate into GMP production to make it available to patients. 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 to plant bioreactor scale
  • 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