APPLICATION NOTE

Viral Clearance Under Mild pH Using Protein A Resins

Viral Clearance Under Mild pH Using Protein A Resins
Achieving reliable viral clearance while protecting product quality is essential in monoclonal antibody (mAb) manufacturing. Traditional Protein A purification methods rely on low‑pH elution (typically pH 3.0–3.5), which can trigger protein aggregation, structural instability, and yield loss. This application note demonstrates how Purolite’s Praesto™ Jetted A50 and Praesto™ Jetted A50 HipH resins enable effective viral reduction even at milder elution conditions, offering a powerful alternative for sensitive molecules.

Why Mild pH Matters
Operating at higher pH (around pH 4.5) significantly reduces the risk of mAb aggregation while maintaining strong viral clearance performance. For biopharmaceutical manufacturers, this means fewer product‑related impurities, improved molecular stability, and a more robust downstream purification process.

Superior Performance with Praesto™ Jetted A50 HipH
The report compares Purolite’s resins with a leading competitor under both standard (pH 3.5) and mild (pH 4.5) conditions using two industry‑standard model viruses—an enveloped virus (MLV) and a non‑enveloped virus (MMV). Results show that Praesto™ Jetted A50 HipH at pH 4.5 achieves impressive log reduction values, reaching up to 4.85 for MLV and 3.85 for MMV, delivering both safety and efficiency. 

Benefits at a Glance
- Effective viral clearance at mild pH, protecting molecule integrity.
- Reduced aggregation risk, allowing higher monomer recovery.
- Comparable or improved performance versus standard Protein A resins. 
- Ideal for sensitive or unstable mAbs, helping maintain critical quality attributes. 


Dive into the detailed data, chromatographic profiles, and method parameters for implementing mild‑pH viral clearance in your purification workflow. This resource is essential for process developers seeking to optimize product quality while maintaining regulatory‑aligned viral safety.