Downstream Process Development (DSP)
Our strategy is to develop customized purification processes for each therapeutic protein drug or monoclonal antibody: purity of product and high yield are priorities. This strategy ensures a very competitive development timeline, while including the application of DOE, high-throughput biophysical and biochemical assays, and automated screening platforms.
Our downstream capabilities match the scale of fermentation. This means that one fermentation batch can be purified in a single run without the need for sub-lotting.
Development of downstream process includes protein purification in different scales using various chromatography techniques. We develop downstream processes which include:
- High protein recovery yield and purity (using DOE);
- Protein purity/impurity analysis;
- Development of protein refolding methods;
- Rapid technology transfer and scale-up to cGMP manufacturing scale
Each DSP step like cell disruption, primary recovery involving solid-liquid separation, isolation and purification of the final product is performed with state-of-the-art equipment.
Downstream process development (DSP) includes harvesting, primaryrecovery, purification and refolding process development. Main equipment used in DSP is:
- Cell disruption in variable scale (High pressure homogenization, sonication)
- Primary recovery involving solid liquid separation (Centrifugation, filtration)
- Isolation (Inclusion bodies washing, refolding optimisation)
- Clarification: centrifugation (Beckman Coultier: from 1 ml to 6 L), filtration (Cogent M1, Pellicon)
- Purification methods: Affinity, Ion Exchange, Gel Filtration, Hydrophobic Interaction, Reversed Phase
- 6 ÄKTA chromatography systems with integrated DOE
- Final product (Tangential flow filtration, Centrifugal Filters, Sterile Filtration)
- Cold room