Removal of Viruses from Human Intravenous Immune Globulin by 35 nm Nanofiltration

Nm, Troccoli; McIver, James; Losikoff, Andrew M.; Poiley, J. A.

doi:10.1006/biol.1998.0164

Cited by 58 publications

(45 citation statements)

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“…. .” for BPV, but not for porcine parvovirus 17 . Whether the recent discovery of another human parvovirus, tentatively named bocavirus and apparently relatively closely related to BPV, but less so to porcine parvovirus, 18 and the consequently possible occurrence of BPV cross‐reactive bocavirus antibodies might explain this earlier finding will be interesting to see.…”

Section: Discussionmentioning

confidence: 92%

Removal of small nonenveloped viruses by antibody‐enhanced nanofiltration during the manufacture of plasma derivatives

et al. 2006

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Section: Discussionmentioning

confidence: 92%

Removal of small nonenveloped viruses by antibody‐enhanced nanofiltration during the manufacture of plasma derivatives

et al. 2006

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“…Consistent removal of HAV and parvovirus demands an effective porosity of 15 nm. While filtration of proteins with a molecular weight above 300 000 and of concentrated protein solutions is more difficult, both factor VIII and IVIG (29) have been processed successfully by nanofiltration; factor VIII entrapment was avoided by first disassociating it from von Willebrand factor (30,31). As a cautionary note, effective filtration depends on the successful manufacture of every filter, and unfortunately the testing of individual filters cannot guarantee their absolute integrity.…”

Section: Nanofiltrationmentioning

confidence: 99%

Efforts in minimizing risk of viral transmission through viral inactivation

Horowitz¹,

Ben‐Hur²

2000

Annals of Medicine

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The viral safety of blood and blood products has improved substantially over the last decade on account of the development of new viral screening and virucidal procedures. For nearly 15 years, virally inactivated blood derivatives, prepared by using advanced virucidal procedures, have amassed an extraordinary safety record with respect to hepatitis B and C and HIV. This record of safety has spawned the development of newer virucidal procedures designed to eliminate nonenveloped viruses from blood derivatives and viruses and other pathogens from blood components, including cellular components. Ongoing tests that include clinical studies will demonstrate how close we are to achieving a blood supply that is free of viruses, bacteria, and parasites.

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“…Rodent‐derived cell lines are widely used in the biotechnology industry and have been shown to contain endogenous DNA for retroviruses and retroviral‐like particles . Murine leukemia virus (MuLV), an enveloped RNA retrovirus, is a key relevant virus, and purification processes are typically developed to demonstrate assurance of clearance well beyond the detected level or limit of detection of the virus titer assay . MVM, a non‐enveloped DNA parvovirus, is another important relevant virus for bioprocessing safety, as there have been examples of process with parvovirus contamination reported in industry .…”

Section: Regulatory Backgroundmentioning

confidence: 99%

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

Sipple

Nguyen

Patel

et al. 2019

Biotechnology Progress

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Biologics produced from CHO cell lines with endogenous virus DNA can produce retrovirus‐like particles in cell culture at high titers, and other adventitious viruses can find their way through raw materials into the process to make a product. Therefore, it is the industry standard to have controls to avoid introduction of viruses into the production process, to test for the presence of viral particles in unclarified cell culture, and to develop purification procedures to ensure that manufacturing processes are robust for viral clearance. Data have been accumulated over the past four decades on unit operations that can inactivate and clear adventitious virus and provide a high degree of assurance for patient safety. During clinical development, biological products are traditionally tested at process set points for viral clearance. However, the widespread implementation of platform production processes to produce highly similar IgG antibodies for many indications makes it possible to leverage historical data and knowledge from representative molecules to allow for better understanding and control of virus safety. More recently, individualized viral clearance studies are becoming the rate‐limiting step in getting new antibody molecules to clinic, particularly in Phase 0 and eIND situations. Here, we explore considerations for application of a generic platform virus clearance strategy that can be applied for relevant investigational antibodies within defined operational parameters in order to increase speed to the clinic and reduce validation costs while providing a better understanding and assurance of process virus safety.

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Removal of Viruses from Human Intravenous Immune Globulin by 35 nm Nanofiltration

Cited by 58 publications

References 0 publications

Removal of small nonenveloped viruses by antibody‐enhanced nanofiltration during the manufacture of plasma derivatives

Removal of small nonenveloped viruses by antibody‐enhanced nanofiltration during the manufacture of plasma derivatives

Efforts in minimizing risk of viral transmission through viral inactivation

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

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