Author Archives: Tomoko Hongo-Hirasaki

Robust Small Virus Removal with Planova® Virus-Removal Filters: No Effect from Varying Virus-Spike Quality and Concentration in a Validation Model

Figure 1. A virus validation study is required for virus-removal filters prior to employing them in a biopharmaceutical purification process. Validation conditions are determined on a case-by-case basis by each filter user. Optimizing conditions for removal of parvovirus is important to achieve LRV = 4. However, the optimal conditions are often unclear for validation studies, because each product may behave differently. We attempt to establish optimal conditions for human IgG and show the effects of varying IgG concentration, purity of the virus…