The downstream process equipment park is designed for:

• purification process development, optimization and robustness testing
• scaling up study
• purification tool for up to 10 g of purified material

Main equipment

• Akta™ Avant 150 chromatography system coupled to set of columns ensuring screening and production

• ultrafiltration systems that can accommodate a large range of membrane areas

Chromatography

• A high throughput screening strategy is proposed in order to determine the optimal resins and chromatographic conditions for binding and elution. The best identified conditions are fine-tuned using small-scale columns. A flow-chart including two to three different chromatographic steps (orthogonal approach) is then designed and tested at larger scale.
• The efficiency of the chromatography steps is monitored using different analytical tools: µBCA (for recovery yield estimation), SDS-PAGE, SE- and RP-HPLC (for purity analysis).

Ultrafiltration

• Ultrafiltration is used for buffer exchange, removal of impurities and formulation in the final buffer.
• Development implies different parameters (membrane type and cut-offs, protein loads, number of diafiltration volumes, pressure conditions…).
• Selection of the best conditions is based on different In Process Controls: UV, SDS-PAGE and SE-HPLC.