Polishing Step Purification of mAbs using Purexa™ MQ
Part 1: HCP and Aggregate Removal from an Acidic mAb Feed
Purilogics®’ Purexa™ MQ multimodal anion-exchange chromatography membrane is differentiated by its high binding capacity and effectiveness in removing impurities such as host cell proteins, virus particles, DNA, and aggregates from biologic products under conditions of high solution conductivity (e.g., > 10 mS/cm) using fast processing speeds. In this post, we highlight it’s superior HCP and aggregate removal performance with a case study of polishing step (after Protein A chromatography) purification of an acidic mAb. We compared Purexa™ MQ to two commercial membrane products.
Figure 1 shows the results from the acidic mAb (pI < 7) using a mAb load of 2 kg/L in Bistris pH 6.5.
• For HCP removal, each membrane column tested performed similarly, reducing the HCP content by about half.
• For monomer composition Purexa™ MQ outperforms the other membranes, increasing the monomer from less than 98% to about 99%.
• Since the feed didn’t contain measurable high molecular weight (HMW) species, this increase in monomer composition was due to the removal of dimer species.
• Purexa™ MQ removed more than half of the dimer species.
This is a multipart series. Check back to our feed soon for Part 2: HCP and Aggregate Removal from a Basic mAb Feed.
Figure 1. Polishing Step Purification of an Acidic mAb using Purexa™ MQ
HCP and Aggregate Removal from a Basic mAb Feed
Purilogics®’ Purexa™ MQ multimodal anion-exchange chromatography membrane is differentiated by its high binding capacity and effectiveness in removing impurities such as host cell proteins, virus particles, DNA, and aggregates from biologic products under conditions of high solution conductivity (e.g., > 10 mS/cm) using fast processing speeds. In this post, we highlight it’s superior HCP and aggregate removal performance with a case study of polishing step (after Protein A chromatography) purification of an acidic mAb. We compared Purexa™ MQ to two commercial membrane products.
Figure 2 shows the results from the basic mAb (pI > 7) using a mAb load of 4 kg/L under three different buffer conditions at pH 8.
• We tested low conductivity ( 1 mS/cm) tris, high conductivity (13 mS/cm) tris, and low conductivity (3 mS/cm) phosphate buffers.
• Purexa™ MQ outperforms the other membranes in HCP removal for all three buffer conditions studied.
• Purexa™ MQ yielded the highest monomer composition, and was the only membrane that increased the monomer composition under every buffer condition.
• Purexa™ MQ resulted in greater dimer and high molecular weight (HMW) species removal.
• Purexa™ MQ was the only membrane that completely removed the HMW species in phosphate buffer..
Figure 2. Polishing Step Purification of an Basic mAb using Purexa™ MQ
