3M Polisher ST Value Cost Analysis in the Manufacturing Process of mAb Replacing AEX Polishing Column

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By Alexei Voloshin, Joris Van de Velde, Hani El-Sabbahy and Himanshu Nivsarkar, 3M’s Separation and Purification Sciences Division

One of the most important purification steps, especially for traditional mAb methods, is the operation of primary capture chromatography. Significant efforts have been made to improve the productivity and efficiency of this affinity capture step.

Single-use chromatography technology provides the flexibility that a multi-product manufacturing facility needs. Several studies have shown that the capital investment required with a single-use facility is lower, and these facilities offer substantial savings in time and labor by eliminating cleaning and cleaning validation procedures.

3M â„¢ Emphaze â„¢ AEX Hybrid Purifier has been widely adopted in upstream production processes bringing chromatography into clarification. With 3M â„¢ Polisher ST, 3M now brings a single-use chromatography solution to the downstream manufacturing space, enabling the replacement of multipurpose chromatography columns.

To improve the overall economics of the process and enable the adoption of single-use equipment at any scale, disposable chromatography solutions must exhibit high throughput capabilities and improve product yield. In this Application Note, we discuss strategies for replacing the downstream polishing AEX column with an advanced single-use AEX solution such as 3M Polisher ST in traditional and modern mAb manufacturing processes.


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