Smart process design
Our smart processes and dedicated project team meet all customer targets when it comes to fermentation output and purity.
Scaling to cGMP production is a two-step process.
Fermentation is all about enabling the microorganisms to produce your valuable product in the most efficient way; while downstream processing is about separating it from the waste.
At DSM we’ve developed specific strategies and recipes to maximize the cell density and product formation in the fermentation broth. We only use fermentation procedures that can be scaled up from the development phases and replicated at the manufacturing level – often by a factor of a thousand without an intermediate step.
Meanwhile we can include chemical and enzymatic process steps in our production processes – which are valuable in the preparation of semi-synthetic drugs, but also for the modifications of proteins by PEGylation. This saves both time and money while increasing reliability.
Benefits in fermentation
- Short and predictable strain and fermentation development timelines
- Ability to scale-up batches in a single step
- Optimization of the fermentation medium composition or fermentation process conditions (Further boosting your product’s productivity or maximize product purity profile)
- Close cooperation between process development and manufacturing departments to ensure watertight transfer.
To accelerate process development even more we apply design of experiments, high-throughput screening (HTS), and automation where possible in the recovery and purification development phase.
For example, we apply HTS to chromatography resin selection and for identifying binding and elution conditions to meet specific purification targets in a methodical way.