Impact of Clarification Technology on Bioprocessing Costs of Goods Sold (COGS)

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

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

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

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

To improve overall process economics and enable the adoption of single-use equipment at any scale, disposable chromatography solutions must exhibit high throughput capabilities and improved 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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