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
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
- 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 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.