Demonstrating A Modular Selectivity With A Weak AEX-HIC Resin For Achieving High mAb Purity And Recovery In A Downstream Process

Chromatographic purification plays a critical role 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 techniques like anion exchange, cation exchange, or hydrophobic interaction chromatography.

However, achieving both high purity and yield has often been challenging with traditional single-mode ion-exchange chromatography methods. To overcome these limitations, the industry has increasingly turned to multimodal adsorbents for purification processes — an innovative solution that not only helps to reduce the number of steps but also improves process economics and achieves sustainability goals.

In this webcast, learn how Bio-Rad’s new Nuvia wPrime 2A Media, a scalable multimodal resin with adjustable selectivity, was employed to design an efficient mAb purification process in a flow-through mode. The purification process demonstrated a 10x reduction of high molecular weight (HMW) species while achieving a high recovery of the mAb monomer.

Key Takeaways:

• A design of experiment (DOE) approach predicted the 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%.