(363f) Virus Filtration: The Most Challlenging Filtration in Biotech Process Lessons from a Successful Product Development

Membrane separations are critical in biotechnology drug production. Membranes enable drug safety by removal of bacteria and viruses and provide a convenient tool for achieving the final drug formulation. One of the most challenging filtration applications in a biotech process is virus filtration. This application requires a 4-log high retention (R>0.9999) of a 20 nm sized parvovirus and a nearly complete passage (R<0.01) of a protein product that is only slightly less than a half of that size. In addition, a high filtration economy is expected, requiring a high filter throughput capacity despite a common presence of small amount of protein aggregates similar in size to the retained virus in the filtered streams.

Development of a successful product based on a new type of membrane will be described. Membrane morphology optimization and device design options will be discussed and trade-offs between performance and cost, robustness and ease of use will be described.