High-capacity multimodal anion-exchange membranes for polishing of therapeutic proteins

Biotechnol Prog. 2021 May;37(3):e3129. doi: 10.1002/btpr.3129. Epub 2021 Jan 29.

Abstract

This contribution reports on a study using Purexa™-MQ multimodal anion-exchange (AEX) membranes for protein polishing at elevated solution conductivities. Dynamic binding capacities (DBC10 ) of bovine serum albumin (BSA), human immunoglobulins, and salmon sperm DNA (ss-DNA) are reported for various salt types, salt concentrations, flowrates, and pH. Using 1 mg/ml BSA, DBC10 values for Purexa™-MQ were >90 mg/ml at conductivities up to 15 mS/cm. The membranes maintained a high, salt-tolerant BSA DBC10 of 89.8 ± 2.7 (SD) over the course of 100 bind-elute cycles. Polishing studies with acidic and basic monoclonal antibodies at >2 kg/L loads showed that Purexa™-MQ had higher clearance of host cell proteins and aggregate species at high conductivity (13 mS/cm) and in the presence of phosphate than other commercial AEX media. Purexa™-MQ also had a high ss-DNA DBC10 of 50 mg/ml at conductivities up to 15 mS/cm, markedly outperforming other commercial products. In addition to the effectiveness of Purexa™-MQ for protein polishing at elevated solution conductivities, its unusually high binding capacity for ss-DNA indicates potential applications for plasmid DNA purification.

Keywords: downstream processing; mixed-mode chromatography; salt-tolerant; single-use chromatography; viral vector purification.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Anion Exchange Resins / chemistry*
  • Antibodies, Monoclonal* / analysis
  • Antibodies, Monoclonal* / chemistry
  • Antibodies, Monoclonal* / isolation & purification
  • Chromatography, Ion Exchange / methods*
  • DNA / chemistry
  • Membranes, Artificial*
  • Sodium Chloride / chemistry

Substances

  • Anion Exchange Resins
  • Antibodies, Monoclonal
  • Membranes, Artificial
  • Sodium Chloride
  • DNA