The new Emphaze AEX Hybrid Purifier is available as laboratory and scale-up capsules, while production capsules will be introduced at the end of the year.
3M's purifier is a hybrid device which integrates both an anionic exchange (AEX) media and a downstream 0.2µm highly asymmetric membrane. It can prevent both cellular debris and soluble impurities reaching the protein-A chromatography column downstream. 3M says that Emphaze AEX Hybrid Purifier can improve column-A performance in terms of product purity and extend column life and integrity by allowing less aggressive cleaning procedures and chemicals. The cleaning regimen is known to have a major effect on column-A capacity fade.
The multi-mechanism AEX media is an all-synthetic Q-functional media that provides defined low level extractables. Its cationic Q-functional chemistry reduces host cell DNA by 4 Log Reduction Value (LRV) or greater and Host Cell Protein (HCP) load by 25-35%, while also exhibiting low non-specific protein binding for high yield of therapeutic proteins.
Increase life cycles
The integrated downstream 0.2 µm membrane reduces Brevundimonas diminuta by more than 6 LRV, lowering the risk of bacterial contamination compared to conventional technologies used at the primary recovery stage of the bioprocess. The hybrid purifier can also be deployed in harvest/centrate feeds of ≤100 NTUs (Nephelometric Turbidity Units) to achieve a clarified solution of <5 NTU, while providing protection for downstream 0.1µm or 0.2µm sterilising membranes and chromatographic stages. This allows the production platform to be designed with smaller sterilising filters, smaller chromatography columns and/or increased column life cycles.
Unlike conventional chromatographic stages, there is no need for column packing and the range is fully disposable.