For drug products manufactured in mammalian cells, safety assurance practices are needed
during production to assure that the final medicinal product is safe from the potential risk of …

Viral clearance studies are mandated prior to entering clinical trials and for commercial
launch of biopharmaceuticals. These studies are a key component of risk mitigation to …

Manufactures of therapeutic biological products are required to incorporate downstream unit
operations that can inactivate or remove potential viral contaminants from the manufacturing …

Protein A chromatography is an effective capture step to separate Fc‐containing
biopharmaceuticals from cell culture impurities but is generally not effective for virus …

Session 2/3: Integrated Viral Clearance Strategy and Case Studies | PDA Journal of
Pharmaceutical Science and Technology Skip to main content Main menu Home Content Current …

This chapter discusses issues to address in designing and incorporating adequate viral
clearance strategies during the production of biologicals and biopharmaceuticals. It focuses …