3M™ Polisher ST Virus Clearance Conquers mAb Solutions

Regulatory authorities require biopharmaceutical companies to demonstrate robust viral clearance by at least two orthogonal process steps. The AEX step is often part of the viral clearance strategy in mAb processes. Being able to demonstrate robust viral clearance under a wide range of process conditions provides flexibility for process development and avoids unwelcome surprises during validation.

Adsorptive depth filters have been shown to provide viral clearance capability by either electrostatic adsorption or a combination of adsorption and mechanical entrapment. However, implementation of adsorptive filters for claimable impurity and virus clearance in GMP manufacturing processes has been hindered by: 1) relatively poor and variable binding capacity (no consistency), 2) lack of testing methods to demonstrate the post-usage filter integrity, and 3) poor understanding of viral clearance mechanism.

Read how the 3M™ Polisher ST is designed to operate in pre- or post-use integrity test conditions, accommodates a wide range of operating conditions and has demonstrated the highest impurity removal rates.