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 …

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

Viral contamination is a potential risk of using biotechnology products derived from
mammalian cell lines. Therefore, to provide assurance of the safety of these products …

Virus filtration is a downstream unit operation in the manufacturing of biotherapeutics to
remove potential viral contaminations based on size exclusion. While even very small …

Virus filtration in biopharmaceutical downstream process ensures viral safety with removal
efficiency greater than 99.99%. Despite its robust performance, it has been reported that …

Regulatory authorities recommend using residence time distribution (RTD) to address
material traceability in continuous manufacturing. Continuous virus filtration is an essential …

There are few reports of the adoption of continuous processes in bioproduction, particularly
the implementation of end‐to‐end continuous or integrated processes, due to difficulties …

Virus filtration is considered an effective and robust method to remove viral contaminants
that may enter the manufacturing process of biotherapeutics. However, insights into the …

Mobile and stationary phase factors were investigated in order to identify conditions for
effective capture of minute virus of mice (MVM), a potential adventitious contaminant in …

The growing interest in process intensification and continuous processing has led to
concerns regarding the performance of virus removal filters at low permeate fluxes. This …