Innovative single-use anionic-exchange/membrane hybrid device now available for laboratory and scale-up applications to protect Protein A column, enhance yield and simplify downstream process
3M has launched a unique single-use platform that removes host cell DNA (HcDNA) and proteins (HCP) in various applications within the bioprocessing industry. The new Emphaze AEX Hybrid Purifier is available as laboratory and scale-up capsules. Production capsules will be introduced at the end of the year.
Emphaze AEX Hybrid Purifiers combine six 3M technologies – including advanced polymers, membranes, non-woven fibres and surface modification – from its repertoire of 46 technology platforms. Emphaze is a hybrid device that integrates both an Anionic EXchange (AEX) media and a downstream 0.2µm highly asymmetric membrane in a single device. The result is a compact design that prevents both cellular debris and soluble impurities reaching the expensive protein-A chromatography column downstream.
Emphaze AEX Hybrid Purifers not only improve column-A performance in terms of product purity but also 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 well 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 very low non-specific protein binding for high yield of therapeutic proteins.
The integrated downstream 0.2µm membrane reduces Brevundimonas diminuta by more than 6 LRV, significantly lowering the risk of bacterial contamination compared with conventional technologies used at the primary recovery stage of the bioprocess. The hybrid purifier also ensures superior clarification; it can 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.
In addition to improving efficiency and protecting more expensive process equipment, Emphaze AEX Hybrid Purifiers are easy to use, scalable and offer reproducible performance. Unlike conventional chromatographic stages there is no need for column packing, negating risk. The range is fully disposable, eliminating the need for cleaning validation, and can be retrofitted into existing 3M hardware platforms.