2020
DOI: 10.1111/trf.16022
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Nanofiltration as a robust method contributing to viral safety of plasma‐derived therapeutics: 20 yearsʼ experience of the plasma protein manufacturers

Abstract: Background: Nanofiltration entails the filtering of protein solutions through membranes with pores of nanometric sizes that have the capability to effectively retain a wide range of viruses. Study Design and Methods: Data were collected from 754 virus validation studies (individual data points) by Plasma Protein Therapeutics Association member companies and analyzed for the capacity of a range of nanofilters to remove viruses with different physicochemical properties and sizes. Different plasma product interme… Show more

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Cited by 28 publications
(30 citation statements)
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“…Large virus (e.g., retrovirus, pseudorabies virus, reovirus 3) removal by small virus filters is robust regardless of the load conditions tested. This was consistent with the size exclusion mechanism and was corroborated by clearance results from more than 2000 validation studies spanning over two decades (Stanley et al, 2021), as well as the experience from the plasma industry (Roth et al, 2020). When small virus filters were used for parvovirus clearance, virus breakthrough has been reported.…”
Section: Integrity Testingsupporting
confidence: 75%
See 1 more Smart Citation
“…Large virus (e.g., retrovirus, pseudorabies virus, reovirus 3) removal by small virus filters is robust regardless of the load conditions tested. This was consistent with the size exclusion mechanism and was corroborated by clearance results from more than 2000 validation studies spanning over two decades (Stanley et al, 2021), as well as the experience from the plasma industry (Roth et al, 2020). When small virus filters were used for parvovirus clearance, virus breakthrough has been reported.…”
Section: Integrity Testingsupporting
confidence: 75%
“…This is because filters are less likely to be influenced by differences in the physicochemical properties of different viruses, and the virus‐resin interactions modulated by operating conditions. Therefore, a virus filtration step is commonly utilized in a well‐designed recombinant therapeutic protein purification process (EMEA, 1996) and also has proven to provide robust performance in the plasma processing industry (Junter & Lebrun, 2017; Roth et al, 2020).…”
Section: Introductionmentioning
confidence: 99%
“…This result has been confirmed with SARS‐CoV‐2 (Azhar EI, accepted abstract 2020; Cerus Inc. personal communication). Plasma can also be secured by Amotosalen and UV‐A illumination for blood transfusion and by nanofiltration since 1995 for protein extraction by LFB 32–35 . Red blood cell packs are not treated but treatment by Amotosalen and UV‐A light is under evaluation by drug agencies and seems to be effective for blood‐borne infection prevention and transfusion efficacy.…”
Section: Discussionmentioning
confidence: 99%
“…It has also become an indispensable technology for the future. Since its practical use in the early 1990s, it has been widely used worldwide as one of the powerful means of virus removal/inactivation in the purification process of plasma-derived medicinal products and biopharmaceuticals (Junter and Lebrun 2017 ; Inouye and Burnouf 2020 ; Roth et al 2020 ). Planova established its position as a robust and efficient virus removal filter in the VF market, especially in the purification processes of plasma fractionation products.…”
Section: Introductionmentioning
confidence: 99%