Virus filtration is employed in most antibody manufacturing processes to achieve robust removal of endogenous and adventitious viruses. The viral filtration step is typically well-behaved and is used as a platform unit operation step for pipeline products. However, for certain products this platform process step didn’t meet the minimum throughput required for commercial scale manufacturing (&gt; 500 g/m<sup>2</sup>). It has been reported that the load material solution properties and impurities in load can drastically impact the viral filter throughput. Therefore, in this study, the impact of load pH, salt concentration and product concentration on the throughput of the platform viral filter was investigated. The load materials used in these studies were also characterized by a series of analytical tests to further understand the mechanism of viral filter fouling. Based on the study results, the optimal design space for the operation of the platform viral filter was defined.

Investigation of variability in the throughput of a platform viral filter

249th National Meeting (2015)

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.