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 …

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

Virus removal by filtration has been an important improvement for the safety margins of
plasma-derived medicinal products and has become a standard manufacturing process step …

The successful implementation of any biologically derived product in human clinical trials
and as a marketed biopharmaceutical requires the critical utilization of effective viral …

Virus safety of biotech-and plasma-derived therapeutics is ensured through complementary
manufacturing and quality control measures that include the control and monitoring of raw …

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 …

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 …

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 …

Virus clearance, a critical aspect of biopharmaceutical manufacturing processes, ensures
the safety of biopharmaceutics. Virus filtration is widely used during biopharmaceutical …

This article introduces the white paper from the 2017 Viral Clearance Symposium. The 5th
Viral Clearance Symposium in Penzberg, Germany, addressed regulatory perspectives …