Demonstrating a Modular Selectivity With a Weak AEX-HIC Resin for Achieving High mAb Purity and Recovery in a Downstream ProcessDemonstrating a Modular Selectivity With a Weak AEX-HIC Resin for Achieving High mAb Purity and Recovery in a Downstream Process

BPI Contributor

January 28, 2025

15 Min View
Bio-Rad BPI Ask the Expert Webcast

Date: Jan 28, 2025

Duration: 15 Min

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This webcast features: Sushmita Koley, PhD, Staff Scientist, Process Chromatography R&D, Bio-Rad Laboratories.

Chromatographic purification process is a critical step in the biomanufacturing of molecules such as monoclonal antibodies (mAbs), bispecific antibodies (BsAbs), and other recombinant proteins. After the initial capture step, polishing chromatography typically involves two to four orthogonal steps using anion exchange, cation exchange, or hydrophobic interaction chromatography.

Although these traditionally operated single-mode ion-exchange chromatography methods have been employed in the downstream processing of biotherapeutics, achieving high purity and yield has often been challenging. To overcome these limitations, there has been a significant increase in the implementation of multimodal adsorbents for purification processes which not only help to reduce the number of steps, but also improves the overall process economics and achieve the sustainability goals.

In this webcast, learn how Bio-Rad's new scalable multimodal resin, Nuvia wPrime 2A Media, with a modulable selectivity was employed for designing a mAb purification process in a flow-through mode. The purification process demonstrated a 10x reduction in the high molecular weight (HMW) species along with achieving a high mAb monomer recovery. Understand how Nuvia wPrime 2A Media, a novel weak anion exchange hydrophobic interaction chromatography (AEX-HIC) resin, can accelerate your method development and benefit your manufacturing processes.

Key Takeaways:

  • A design of experiment (DOE) approach was employed to predict effective clearance of aggregates or HMW species.

  • Nuvia wPrime 2A Media reduced HMW species by over 10x from the load to the purified pool while achieving a total mAb monomer recovery of 85%.

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