Application Of A Dual Spiking Strategy In Viral Clearance Studies

Ensuring the viral safety of biopharmaceuticals remains a foundational requirement for patient protection, and modern development relies on a balanced strategy of prevention, detection, and removal. For products expressed from well‑characterized rodent cell lines, regulatory guidelines call for viral clearance studies that challenge processes with both xenotropic MLV and MMV—two model viruses selected for their relevance, stability, and ability to stress downstream operations. Because parvoviruses are exceptionally resilient and difficult to remove due to their small size, these studies can be time‑intensive and place significant demand on clinical material. Explore an alternative spiking strategy designed to streamline viral clearance studies by shortening spiked‑run timelines and reducing material use, while still meeting ICH expectations.

Access the full application note to learn how this approach can support efficient, compliant process development.