3M Purification has introduced a new purification technology designed to help biopharmaceutical manufacturers achieve high product purity early in the manufacturing process. The new 3M Emphaze AEX Hybrid Purifier combines three 3M technologies—advanced polymer materials, fine fiber nonwovens, and membranes—to deliver an all-synthetic clarifying product line containing both a novel anion exchange nonwoven media, and a fine particle, bioburden reduction membrane. The Emphaze AEX Hybrid Purifier laboratory and scale-up capsules will be launched in mid-2014, with the production capsules to be launched at the end of the year.
"The Emphaze AEX Hybrid Purifier is a multi-mechanism clarifying device," says Tom Martin, global business manager, life sciences process technologies, 3M Purification. "This product actually represents a new class of clarifying products, with an all-synthetic construction, substantial chromatographic capability, and a defined 0.2 m pore size."
The product is an integral combination of two types of media—Q-functional nonwoven and membrane—that work together to provide product purity after clarification when using a single unit operation. The defined pore size of the qualifying membrane provides removal of insoluble particles below 0.1 um in size, resulting in superior turbidity reduction says the company. At the same time, the high chromatographic capacity of the Q-functional nonwoven provides substantial reduction of negatively charged, soluble impurities including DNA and HCP. This combination of attributes allows the hybrid purifier to provide product purity before and, most importantly, after the protein A column, enabling a novel and simple post protein A mAb purification process.
"We designed the Emphaze AEX Hybrid Purifier to provide the highest possible level of product protein purity early in biopharmaceutical downstream process. What is truly exciting is that by targeting the removal of particularly problematic impurities from entering the protein A column, a profound impact on the entire downstream process can be realized," says Greg Jellum, global laboratory manager, life sciences process technologies, 3M Purification.
The Emphaze AEX Hybrid Purifier offers a loading capacity similar to fine grades of highly-charged conventional depth filters, and can be incorporated into existing manufacturing processes where such a depth filter would be used. The Emphaze AEX Hybrid Purifier will be encapsulated in 3M's signature single-use capsule design, thereby providing the opportunity to minimize capital in a matched component harvest solution. By providing the best possible protection of valuable downstream unit processes, the technology holds potential for improving efficiency in the production of mAb drugs for conditions including various cancers, as well as autoimmune diseases like rheumatoid arthritis and Psoriasis.