Process Development /

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.

DSP development

 

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