Removal of small non‐enveloped viruses by nanofiltration

Abstract

These data suggest that viruses in the presence of certain kinds of amino acids could be aggregated and effectively removed by a filter that has a pore size larger than the size of the viruses.

Electron microscopic estimation of removal of parvovirus B19 (HPVB19) by nanofiltration with a novel filter membrane

“…The sections demonstrate virus trapping at the inner side compared to those of the purified virus filtration (Table 2). This shift is thought to indicate that virus particles have become larger in size or formed aggregations with immune complexes in the plasma as described by Yokoyama et al [26].…”

“…Nanofiltration is considered to be one of the most effective virus reduction methods in the process of blood manufactures because this method is a mechanical elimination of infectious agents from solutions on the basis of their diameter [21,22,[25][26][27] without any chemical or physical effects. In the present study, therefore, the capacity for microparticle removal of BMMs (BMM35, BMM20, and BMM15) which are the main component of the novel virus removal filter, Planova, was examined using solutions containing 20 nm-golds or purified HPVB19 particles and plasma from a HPVB19-patient.…”

“…The Planova filter consists of hollow cellulose fibers of Bemberg microporous membrane (BMM) manufactured by means of a microphase separation method using a regenerated cellulose cuprammonium solution [21,22]. It is proposed that the Planova can achieve a thousand-fold reduction in the level of virus particles from suspensions [23][24][25][26]. The capacity of BMMs to accumulate a large number of particles or molecules in the wall is thought to be attributable to the structure of the membrane.…”

Suitability of a generic virus safety evaluation for monoclonal antibody investigational new drug applications

“…The use of small virus retentive filters is another robust method to ensure the removal of large viruses, such as MuLV, as well as small viruses, such as MVM, from production processes . As filters remove viruses predominantly by a size‐exclusion mechanism, large viruses should be completely retained with the use of a small virus retentive filter .…”

Scale-up of monoclonal antibody purification processes

“…In recent years, the availability of small pore size filters specifically designed for virus removal has driven an expectation that these filters will be incorporated into manufacturing processes for improved removal of small viruses, e.g. Minute Virus of Mice (MVM) [22]. However, these filters are expensive and the greater the volume of product filtered per unit membrane area, the lower the level of virus reduction.…”