The Emphaze™ AEX Hybrid Purifier is an all-synthetic, multi-mechanism clarifying product that contains a Q-functional anion exchange media and a fine particle, bioburden reduction membrane. This product can substantially reduce turbidity, DNA, HCP and bioburden for improved downstream purification.
Robustness performance defines our Emphaze™ AEX Hybrid Purifier. Users may see substantial reductions of DNA by more than 99.99%, as well a reduction in host cell proteins (HCP) of 25-35%. This clarifying product may also reduce bioburden by more than 99.9999% of Brevundimonas diminuta and turbidity reduction to often less than 5 NTU. The mAb recovery is often equal to or greater than 95%. These attributes may contribute to enhancing the contaminant clearance performance of protein A columns.
This type of purification is crucial because high levels of DNA may lead to protein precipitation or aggregation – either before or after the protein A column. Similarly, relatively high levels of HCP are seen in perfusion harvest and a large amount of HCP co-elutes with the protein from the Protein A column. The challenge for the downstream purification process is to consistently reduce DNA, HCP and other levels in the final product. Emphaze™ AEX Hybrid Purifier helps meet this challenge by providing consistent reduction of HCP, DNA and other undesirable elements.
How it Works
Emphaze™ AEX Hybrid Purifier is an all-synthetic, multi-mechanism clarifying single-use capsule containing a synthetic Q-functional anion exchange media integrated with a fine particle, bioburden reduction membrane. The anion exchange media is comprised of a quaternary amine hydrogel supported by a fine fiber nonwoven scaffold. Multiple 3M technology platforms were leveraged to produce a hyper-functionalized high purity polypropylene nonwoven containing covalently attached, thermally stable, water soluble polymer. The functional polymer accounts for roughly two-thirds of the mass of the anion exchange media.
The bioburden reduction membrane is a highly asymmetric, high loading capacity polyamide membrane which has distinct zones of decreasing pore size spanning a roughly 20X range and terminating with a 0.2 µm bioburden reduction rated pore size. All components of the Emphaze™ AEX Hybrid Purifier are compliant with United States Pharmacopeia (USP) <88> Class VI 70°C Biological Reactivity Tests, in vivo.
Using Science to Improve Filtration
The 3M™ Emphaze™ product represents a class of purification products that can be utilized to help redefine the manufacturing processes for the production of therapeutic proteins and other biologics. At 3M Purification Inc. we are committed to apply science to filtration and providing you with quality products.
Our technology, products and innovation reflect what we do for our customers every day: advance, enhance and improve their products and processes to enable their success. 3M Purification's dedicated technical services and laboratory personnel help solve customers’ most arduous separations problems. Our engineers work to provide solutions that reduce the overall cost of ownership and our researchers are constantly working on breakthroughs that make new separations platforms possible. Every day our products are used by researchers, process developers and manufacturing personnel for critical filtration, separation and process monitoring steps in the biopharmaceutical industry.