3M reports achieving high product purity early in the manufacturing process and improving efficiency and economics is important to biopharmaceutical manufacturers.
3M notes increasing removal of impurities like DNA and HCP during clarification improves the performance of downstream capture and polishing steps.
The 3M Emphaze™ AEX Hybrid Purifier meet these challenges through reduction of cell debris, DNA and HCP at clarification to help improve downstream process steps. The new Emphaze capsules are sterilization/sanitization compatible and can be used across various aqueous based biopharmaceutical processes, including vaccine purification. Additionally, the improved Emphaze AEX Hybrid Purifier products now feature two new laboratory capsules and one scale-up capsule that allows evaluations at laboratory and scale-up volumes.
“Customer input is critical in evaluating the performance and effectiveness of any product to maximize performance,” said Himanshu Nivsarkar, Global Marketing Manager, 3M Separation and Purification Sciences Division. “With the Emphaze AEX Hybrid Purifier, customers experience benefits in typical monoclonal antibody purification processes, including nominal 30% HCP and greater than 4 log DNA reduction. It has a consistent output turbidity (<5 NTU) leading to potential downsizing of the sterilizing grade membrane and increased product purity post-protein A. This also reduces turbidity post viral inactivation/neutralization step leading to a lower impurities load on the downstream AEX column, thus allowing customers to optimize their processes.”
Emphaze AEX Hybrid Purifier products are synthetic multi-mechanism single-use purifier products used for biopharmaceutical clarification. They deliver consistent, high purity clarified process fluid by removing soluble and insoluble impurities, such as DNA, HCP, and cell debris, through a combination of chromatographic and size exclusion mechanisms. Emphaze AEX Hybrid Purifier products combine three unique 3M technologies — advanced polymer materials, fine fiber nonwovens, and membranes — to deliver a synthetic clarifying product line containing a novel anion exchange nonwoven media and a fine particle, reduction membrane.