Virus filtration is a key component of the overall virus clearance strategy in the manufacture of life saving biopharmaceuticals such as therapeutic monoclonal antibodies (mAb). An effective virus filter must provide high levels of viral clearance while insuring adequate protein transmission / recovery and good capacity (volume of feed that can be processed per unit membrane area). This is a particular challenge for parvovirus filters since the parvovirus (typically 18 – 26 nm in size) is only a few times larger than the therapeutic protein. The cost of virus filters can often approach that of Protein A resins, contributing as much as 15% of the overall cost of the downstream purification process.

Although the Viresolve^® Pro (V-Pro) filter is used quite extensively in commercial manufacturing processes, many companies have experienced serious fouling and capacity issues during commercial process development for some biotherapeutics, making use of the V-Pro filter impossible and/or unacceptable.

The overall objective of this project will be to address the current knowledge gap in the development of effective virus filtration processes, with a specific focus on understanding the key physical properties of the feed stream governing the performance of the Planova^TM BioEX filter when used for heavily fouling process streams.