Viral filtration is an integral part of downstream processes for biopharmaceutical products in which viruses and other contaminants are effectively removed by nanofiltration. Planova filters are operated in dead-end mode by either constant pressure or constant flow rate control. In cases where strict pressure control is required, Asahi Kasei Bioprocess recommends using constant pressure control, either by house air or compressed air tanks. However, little is known about how pressure fluctuation during filtrations affects virus removal. In this study, we examined the effects of pressure fluctuation on viral clearance when using constant pressure control and constant flow rate control by peristaltic pump with one or two pump heads. A total of 16 filtrations using a protein feed of 5 g/L BSA with porcine parvovirus (PPV) spike (virus challenge, 10.5 logs TCID50/m2) were conducted on 0.001 m2 Planova 20N filters according to manufacturer recommendations with pressure readings taken every 2 s. Filtrations were conducted in duplicate using constant pressure control by compressed air and using constant flow rate control by a peristaltic pump with one or two pump heads. Constant pressure runs were conducted at 8 psi (low pressure), &lt;14.2 psi (manufacturer recommended maximum operating pressure) and 18 psi (high pressure). Target pressure for constant flow rate control with two pump heads was 6 – 8.5 psi, &lt;14.2 psi and 16 – 18 psi, respectively. Constant flow rate control with one pump head was conducted in the range of 7 – 18 psi and &lt;14.2 psi. The constant flow rate control runs represent exaggerated conditions with pressure fluctuation of &gt;9 psi for constant flow rate with one pump head and relatively limited fluctuation of &lt;4 psi for constant flow rate with two pump heads. The process volume was 150 mL, collected in two equal fractions, and PPV assay was conducted to determine viral clearance for each run. Pressure fluctuation during filtration runs did not cause marked decreases in PPV LRV under the conditions tested.

Evaluation of pressure fluctuation in constant pressure and constant flow rate control and effects on viral clearance

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

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