Process Economic Analysis: Impact Of Clarification Technology On Bioprocessing Costs Of Goods Sold (COGS)

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

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

Single-use chromatography technology offers the flexibility which a multiproduct manufacturing facility requires. 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.

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

To improve the overall process economy and allow adoption of single-use equipment at any scale, disposable chromatography solutions need to show high throughput capacities and improve the product yield. In this application note, we discuss strategies for replacing the downstream polishing AEX column with an advanced single-use AEX solution like 3M Polisher ST in traditional and modern mAb manufacturing processes.