Predicting CHO Retroviral Particle Clearance

Viral contamination is an inherent risk during the manufacture of biopharmaceutical products. Whether introduced initially from raw materials or later through specific manufacturing operations, unmitigated viral contamination has led to serious health implications and plant shutdowns. Global regulatory agencies require sponsoring companies to validate the viral clearance efficacy of their purification process steps prior to clinical trials or regulatory approval.

Cygnus’ MockV® technology addresses the barriers imposed by live viral clearance studies through the novel and patent-protected use of viral surrogates, or “Mock Viral Particles (MVPs)."