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