3M has introduced production-scale variants of its advanced Emphaze AEX Hybrid Purifier that delivers early purification by removing Host-cell DNA (HcDNA) upstream of the protein-A chromatography column. Following the 2014 launch of the high-performance upstream purifiers, in laboratory and scale-up sizes, the latest introduction completes the Emphaze AEX Hybrid Purifier Range and is sized for large-scale production applications at process volumes up to 25,000 litres. The hybrid purifiers integrate both an Anionic Exchange (AEX) media and 0.2µm highly asymmetric membrane in a compact device that reduces both cellular debris and soluble impurities. The media is all-synthetic and has a cationic Q-functional chemistry that reduces host cell DNA by at least 4 Log Reduction Value (LRV), which is equivalent to 99.99%. In addition, host-cell protein (HCP) load is reduced by 25-35% and very low non-specific protein binding ensures a high yield of therapeutic proteins. Emphaze AEX Hybrid Purifier’s advanced media is able to achieve superior monoclonal antibody (mAb) recovery surpassing the conventional techniques currently in use. The 0.2µm membrane reduces Brevundimonas diminuta by more than 6 LRV (99.9999%), which significantly lowers the risk of bacterial contamination. Clarification is also greater, allowing a clarified solution of <5 NTU (Nephelometric Turbidity Units) while providing a level of protection that helps maximise protein-A column life cycles and allows the production platform to be designed with smaller sterilising filters and smaller chromatography columns downstream.
