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We explored the impact of a novel single use technology employing chromatographic principle-based clarification for a process-intensified cell line technology. In this study, a 16% economic benefit ($/g) was observed using a single-use chromatographic clarification compared to traditional single-use clarification technology by improving the overall product cost through decreased operational complexity, higher loading capacity, increased product recovery, and higher impurity clearance.

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As therapies have grown in complexity, some drug manufacturing platforms have lost viability. To address a variety of modalities while continuing to operate efficiently, it is necessary to reinvent how physics and chemistry are utilized within these separation technologies.

Read now (PDF, 789 KB): 3M embraces the alignment of our culture with that of customers who pursue high-risk initiatives with a goal of accomplishing truly disruptive outcomes.

The use of the 3M™ Harvest RC Chromatographic Clarifier, a single-stage chromatographic clarification product, is identified as an alternative strategy to a three-stage filtration train. Using bioprocess cost modeling, the overall cost of the clarification process was reduced by 17%–30% through process compression, depending on bioreactor scale.

Read our recent co-publication with Ambrx