As shown in Table 1, filtration performed in validation studies reported here removed all of the enveloped viruses studied (HIV, PRV Lapatinib and BVDV) but also a small non-enveloped virus, BPV. Although BPV is 18–24 nm in size, removal of viruses smaller than the nominal

pore size of the nanofilter was due to antibody-complexed virus particles [17], [18] and [19]. The results presented here demonstrate that the production process of Biotest IGIV employs three effective steps for inactivation and/or removal of enveloped and non-enveloped viruses. Virus reduction is caused by different mechanisms of action, thus viruses, which might escape one procedure, are inactivated or removed by one of the subsequent procedures. In addition to the three virus inactivating/removing steps, low pH, although not a dedicated inactivation step, can also contribute to virus inactivation of some sensitive viruses in a limited range. Guidelines on virus validation for plasma derivatives [1] and [2] require a capacity of virus removal and inactivation, which can reliably remove a potential load of adventitious viruses. Virus inactivation or removal of enveloped viruses learn more of at least 4.0 log10 by two steps and for non-enveloped viruses by one step of is considered as sufficient. The virus validation results for the IGIV presented

here fulfills those requirements. In conclusion, the robust virus removal and inactivation procedures used in Biotest Pharmaceuticals IGIV production remove the enveloped and non-enveloped blood-borne viruses that are known today and has the potential to remove a broad range of emerging pathogens that might contaminate future blood supplies. The three virus inactivation and/or removal procedures described here show high efficacy in inactivation and/or removal of test viruses and relevant viruses and in combination with selection of donors, careful screening medroxyprogesterone serologically and by NAT, a virus

safe final IGIV product results. The production process of Biotest IGIV employs several steps, which are capable to remove prions. Those steps are cold ethanol fractionation, nanofiltration and column chromatography [20], [21] and [22], as reported in abundance in the literature. However, product specific studies on the removal of prions were not performed, as Biotest IGIV is produced from US plasma only. In the US until today not a single native case of variant Creutzfeldt Jakob Disease (vCJD) was reported. Consequently, the probability of a plasma donation at risk for vCJD entering a plasma pool is extremely low. The risk R, calculated using the formula R=1−(1–p)n [23], is less than 1 donation at risk per 100,000 plasma pools for a prevalence p of <1 case of vCJD per 305,000,000 US residents and plasma pools of n=3000 donations.