Viral Clearance Under Mild pH Using Protein A Resins

Maintaining high viral clearance while reducing protein aggregation is a constant challenge in monoclonal antibody (mAb) purification. This application note explores Purolite’s innovative chromatography resins, Praesto™ Jetted A50 and Praesto™ Jetted A50 HipH, which offer a solution to this problem. By operating at milder elution pH levels (pH 4.5), these resins minimize the risk of protein aggregation, thereby preserving yield, without compromising on viral clearance efficiency.

The study compares these resins to a leading competitor under both typical (pH 3.5) and mild (pH 4.5) conditions, using two model viruses — one enveloped (MLV) and one non-enveloped (MMV). Results demonstrate that Praesto™ Jetted A50 HipH at pH 4.5 exhibits superior viral reduction capabilities for both viruses, showing log reduction values up to 4.85 for MLV and 3.85 for MMV. This performance makes the resin an ideal choice for biopharmaceutical processes, ensuring both product safety and quality.

Learn how adopting milder conditions can optimize your mAb purification processes while achieving consistent viral clearance. Read on to uncover these key insights into improving both efficiency and outcomes in biomanufacturing.