Small virus (parvovirus) retentive filtration provides a robust, size based mechanism for removal of small, non-enveloped chemically resistant viruses. For multiple recent filtration processes, the input parameter with the largest impact to throughput and processing time has been load protein concentration; this presentation will summarize research performed to characterize this concentration dependent parvovirus filter fouling. Dynamic light scattering was utilized to determine the impact of protein concentration on diffusion coefficient for multiple MAbs, leading to the calculation of the diffusion interaction parameter (kD) of each MAb, which can be correlated to decreases in initial permeability observed at increasing protein concentration. This correlation allows the screening of MAbs for protein concentration dependent fouling behavior without performing any filtration trials; additionally, multiple load conditions (pH, conductivity, buffer excipients) can be screened in a high throughput manner to determine their impact on kD. The magnitude of the initial permeability drop can vary depending on the parvovirus filter tested; three current generation parvovirus filters from separate vendors were assessed. A case study will be presented where load concentration can be optimized for a given process to minimize filtration area or processing time.

Characterizing protein concentration dependent parvovirus filtration fouling

253rd National Meeting (2017)

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