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

The manufacturing processes of biological medicinal products are expected to be capable of
removing and/or inactivating viruses, to primarily provide for adequate safety margins to …

Virus clearance is critically important to biopharmaceutical manufacturers. One key strategy
enjoined in regulatory guidelines is to assess the ability of downstream unit operations to …

Virus removal filtration processes in biopharmaceutical manufacturing are developed,
optimized and validated for viral clearance using laboratory scale filters. Thus, the scalability …

Evaluating a virus filter should, in theory, be a straightforward exercise. Membrane-based
filtration is a robust virusreduction technology that plays an important role in virus safety for …

This report provides a high-level summary of the key outcomes and gaps based on the
research presented at the 2019 Viral Clearance Symposium and identifies new areas for …

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 steps are essential for maintaining the safety and integrity of
biopharmaceutical products. ICH Q5A mandates that the manufacturing process remove or …

The production of biopharmaceutical products carries an inherent risk of contamination by
adventitious viruses. Historically, these manufacturing processes have incorporated a …

Virus filtration with nanometer size exclusion membranes (“nanofiltration”) is effective for
removing infectious agents from biopharmaceuticals. While the virus removal capability of …