ST. PAUL, Minn. –– 3M Purification’s new purification technology platform,

under the 3M Emphaze brand, is designed to help biopharmaceutical manufacturers achieve high

product purity early in the manufacturing process, improving efficiency and process economics.

The new 3M™ Emphaze™ AEX Hybrid Purifier, the first in a series of single-use chromatographic

products, uniquely combines three 3M core technologies — advanced polymer materials, fine fiber

nonwovens, and porous membranes — into a novel purification media. The result is an allsynthetic

clarifying product line containing both a novel anion exchange nonwoven media and a

fine particle, bioburden reduction membrane. In addition to the 3M Emphaze AEX Hybrid Purifier

Laboratory and Scale-Up single-use capsules introduced in July, the 3M Emphaze AEX Hybrid

Purifier family is now completed with the introduction of two new Production capsules.

“The 3M Emphaze AEX Hybrid Purifier is a multi-mechanism clarifying product,” said Tom

Martin, Global Business Manager, Life Sciences Process Technologies, 3M Purification. “This,

actually, represents a new class of clarifying products, with an all-synthetic construction, substantial anion exchange capacity, and a defined 0.2 ?m pore size membrane.”

The product is an integral combination of two types of media (Q-functional nonwoven and

membrane) that work synergistically together to provide unsurpassed product purity after

clarification when using a single unit operation. The unique nonwoven hydrogel together with the

qualifying membrane provides tremendous removal of insoluble particles well below 0.1 µm in

size, resulting in superior turbidity reduction. 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. When used in mAb purification, this combination of attributes

allows the hybrid purifier to provide superior product purity before the protein A affinity column, which in turn results in even greater purity downstream of the protein A operation. In turn, high purity product enables significant process simplification in downstream processes.

“We designed the 3M 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,” said Greg Jellum, Global

Laboratory Manager, Life Sciences Process Technologies, 3M Purification. “This new product

platform is a tremendous demonstration in leveraging 3M’s materials-based technology engine to

enable integrated process innovation for our industry.”

The 3M Emphaze AEX Hybrid Purifier offers a loading capacity similar to fine grades of highlycharged

conventional depth filters, and can easily be incorporated into existing manufacturing

processes where such a depth filter would be used. The 3M Emphaze AEX Hybrid Purifier will be

encapsulated in 3M’s signature single-use capsule design. This common product design and

hardware platform enables seamless integration into a 3M matched component solution with high

capacity Zeta Plus depth filtration and LifeASSURE sterilizing grade membranes for a state-of-theart

harvest and clarification process. By providing the best possible protection of valuable

downstream unit processes, the 3M Emphaze AEX Hybrid Purifier technology holds significant

potential for improving efficiency in the production of mAb drugs, other mammalian or bacterial

culture produced recombinant proteins or viral vectors, or plasma fractionation processes.