3M has introduced production-scale variants of its Emphaze AEX Hybrid Purifier that provides early purification of mammalian cell cultures by removing Host-cell DNA (HcDNA) upstream of the protein-A chromatography column.
The latest product completes the Emphaze AEX Hybrid Purifier range and is for large-scale production applications at process volumes up to 25,000 litres. 3M provides support for biopharmaceutical organisations at all stages from laboratory studies to full-scale manufacturing.
Upstream removal of HcDNA using Emphaze AEX Hybrid Purifiers helps increase column-A output purity, and also allows less aggressive column-A cleaning, thereby helping to enhance column life and integrity, the company says.
The hybrid purifiers integrate both an Anionic Exchange (AEX) media and 0.2µm asymmetric membrane filter 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 company says.
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.
All Emphaze AEX Hybrid Purifiers are fully disposable, eliminating the need for cleaning validation, and can be retrofitted into existing 3M hardware.