Single-use Purification Media Improves Efficiency

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The all-synthetic 3M Emphaze AEX Hybrid Purifier contains both an anion-exchange nonwoven media and a fine-particle, bioburden reduction membrane.


 

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, combines three 3M core technologies-advanced polymer materials, fine fiber nonwovens, and porous membranes-into a novel purification media. The all-synthetic clarifying product line contains both an anion-exchange nonwoven media and a fine-particle, bioburden reduction membrane. 3M recently introduced production capsules, which are an addition to the laboratory and scale-up single-use capsules introduced in July 2014.

The product is an integral combination of two types of media (Q-functional nonwoven and membrane) that work synergistically together to provide product purity after clarification when using a single-unit operation. The nonwoven hydrogel together with the qualifying membrane remove insoluble particles well below 0.1 µm in size to reduce turbidity. At the same time, the chromatographic capacity of the Q-functional nonwoven reduces negatively charged, soluble impurities including DNA and HCP. The hybrid purifier can be used in monoclonal antibody (mAb) purification before the protein A affinity column, which results in greater purity downstream of the protein A operation. In turn, high purity product enables significant process simplification in downstream processes.

Source: 3M Purification