Prevalance of hepatitis C virus in plasma pools and the effectiveness of cold ethanol fractionation

Scheiblauer, Heiner; Nübling, Micha; Willkommen, Hannelore; Löwer, Johannes

doi:10.1016/s0149-2918(96)80196-2

Cited by 12 publications

(5 citation statements)

References 33 publications

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“…Clearance of BVDV in our study was not as robust as expected for a virus with a mean diameter of ≈ 40–60 nm. Other investigators using different viral‐clearance techniques have also found BVDV to be unpredictable [13,14]. Because of the tendency for BVDV to induce lysis of cells in culture, the filtration of the BVDV spike material was difficult.…”

Section: Discussionmentioning

confidence: 99%

Incorporation of an additional viral‐clearance step into a human immunoglobulin manufacturing process

Holten

Ciavarella

Oulundsen³

et al. 2002

Vox Sanguinis

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Section: Discussionmentioning

confidence: 99%

Incorporation of an additional viral‐clearance step into a human immunoglobulin manufacturing process

Holten

Ciavarella

Oulundsen³

et al. 2002

Vox Sanguinis

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“…addition of filter aid and filtration) is likely to be limited. Overall, our data indicate that precipitation of fraction III can be considered as a reproducible contributing virus‐removal step [30].…”

Section: Discussionmentioning

confidence: 97%

Viral safety of Nanogam®, a new 15 nm‐filtered liquid immunoglobulin product

et al. 2005

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The manufacturing process of Nanogam comprises two effective steps for the reduction of LE viruses and one for NLE viruses. In addition, the precipitation of Cohn fraction III and the presence of neutralizing antibodies contribute to the total virus-reducing capacity of Nanogam. The overall virus-reducing capacity was > 15 log(10) for LE viruses. For the NLE viruses B19, CPV and EMC, the overall virus-reducing capacities were > 10, > 7 and > 9 log(10), respectively. Including the contribution of immune neutralization, the overall virus-reducing capacity for B19 and HAV is estimated to be > 10 log(10).

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“…Changes in the finishing steps used to remove ethanol from the final product were initially ascribed as the cause of the different infectivity of these IV preparations compared to their IM counterparts ( 25 ), as the Cohn system common to both products was considered to have a high HCV clearing capacity ( 26 ). This was subsequently shown to be modest in the absence of a specific virus inactivating step ( 27 ). Such steps were introduced into the manufacture of IVIG from the early 1990s onward, but not in time to prevent two major outbreaks of HCV in recipients of intravenous Ig.…”

Section: Pathogen Transmission Issues In Ig Therapiesmentioning

confidence: 99%

Manufacture of Immunoglobulin Products for Patients with Primary Antibody Deficiencies â€“ The Effect of Processing Conditions on Product Safety and Efficacy

Farrugia

Quinti

2014

Front. Immunol.

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Early preparations of immunoglobulin (Ig) manufactured from human plasma by ethanol (Cohn) fractionation were limited in their usefulness for substitution therapy in patients with primary antibody deficiencies (PAD), as Ig aggregates formed during manufacture resulted in severe systemic reactions in patients when given intravenously. Developments in manufacturing technology obviated this problem through the capacity to produce concentrated solutions of intact monomeric Ig, revolutionizing PAD treatment and improving patient life expectancy and quality of life. As the need for Ig has grown, manufacturers have refined further manufacturing technologies to improve yield from plasma and produce therapies, which are easier and less expensive to deliver. This has led to the substitution, partly or wholly, of ethanol precipitation by other techniques such as chromatography, and has also stimulated the production of highly concentrated solutions capable of rapid infusion. Ig products have been associated, since their inception, with certain adverse events, including infectious disease transmission, hemolysis, and thromboembolism. The introduction of standardized manufacturing processes and dedicated pathogen elimination steps has removed the risk of infectious disease, and the focus of attention has shifted to other problems, which appear to have increased over the past 5 years. These include hemolysis and thromboembolism, both the cause for substantial concern and the subject of recent regulatory scrutiny and actions. We review the development of manufacturing technology and the emerging evidence that changes for the optimization of yield and convenience has contributed to the recent incidents in certain adverse events. Industry measures under development will be discussed in terms of their potential to improve safety and optimize care for patients with PAD.

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Prevalance of hepatitis C virus in plasma pools and the effectiveness of cold ethanol fractionation

Cited by 12 publications

References 33 publications

Incorporation of an additional viral‐clearance step into a human immunoglobulin manufacturing process

Incorporation of an additional viral‐clearance step into a human immunoglobulin manufacturing process

Viral safety of Nanogam®, a new 15 nm‐filtered liquid immunoglobulin product

Manufacture of Immunoglobulin Products for Patients with Primary Antibody Deficiencies â€“ The Effect of Processing Conditions on Product Safety and Efficacy

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