Comprehensive Virus Clearance Evaluation of the Sartobind^® Q Membrane

This study evaluates the virus clearance potential of the Sartobind^® Q membrane adsorber in the purification process of four biologics (mAb, DVD, Bispecific 1, and Bispecific 2). Virus clearance is a critical regulatory requirement; with murine minute virus (MMV) used as a model "worst-case" virus. The work investigates scalability (Pico vs Nano devices), maximum loading capacities, and compares Sartobind^® Q with competitor membranes.

Key Takeaways:

1. Scalability and Device Equivalence – Sartobind® Q Nano (1 mL) and Pico (0.08 mL) devices showed comparable virus clearance, validating Pico’s use in studies with limited material.
2. High Virus Retention – Two molecules (mAb, Bispecific 1) maintained >5 log virus reduction at high loading (up to 20 kg/L), while DVD and Bispecific 2 showed strong retention (>4 LRV) at lower capacities.
3. Superior Performance vs Competitor – Sartobind® Q membranes consistently outperformed competitor membranes in virus retention across all molecules, even at higher load capacities.