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

Terpstra, Fokke G.; Parkkinen, Jaakko; Tölö, Hannele; Koenderman, Anky H. L.; Hart, Hendricus G J ter; Bonsdorff, Leni von; Törmä, E; Engelenburg, F.A.C. van

doi:10.1111/j.1423-0410.2005.00710.x

Cited by 33 publications

(28 citation statements)

References 32 publications

(38 reference statements)

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“…Nanogam is manufactured by fractionation of pooled human plasma. The fraction containing IgG is processed as described by Van der Meer and colleagues and Terpstra and colleagues . For the preparation of Nanogam, plasma donations of at least 1000 up to 27,000 donations are pooled.…”

Section: Patient and Methodsmentioning

confidence: 99%

Anti‐SSA antibodies are present in immunoglobulin preparations

et al. 2014

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Section: Patient and Methodsmentioning

confidence: 99%

Anti‐SSA antibodies are present in immunoglobulin preparations

et al. 2014

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“…However, current guidelines recommend the use of at least two complementary process steps for the removal of enveloped viruses and one for the removal of non-enveloped viruses, in order to maximize the number and type of pathogens removed and/or inactivated [10]. Most of the currently available IVIG preparations use a combination of three or more process steps for virus and prion inactivation and removal [24, 41–43]. …”

Section: Discussionmentioning

confidence: 99%

Pathogen Safety of a New Intravenous Immune Globulin 10% Liquid

et al. 2017

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BackgroundThe manufacturing process of a new intravenous immune globulin (IVIG) 10% liquid product incorporates two dedicated pathogen safety steps: solvent/detergent (S/D) treatment and nanofiltration (20 nm). Ion-exchange chromatography (IEC) during protein purification also contributes to pathogen safety. The ability of these three process steps to inactivate/remove viruses and prions was evaluated.ObjectivesThe objective of this study was to evaluate the virus and prion safety of the new IVIG 10% liquid.MethodsBovine viral diarrhea virus (BVDV), human immunodeficiency virus type 1 (HIV-1), mouse encephalomyelitis virus (MEV), porcine parvovirus (PPV), and pseudorabies virus (PRV) were used as models for common human viruses. The hamster-adapted scrapie strain 263K (HAS 263K) was used for transmissible spongiform encephalopathies. Virus clearance capacity and robustness of virus reduction were determined for the three steps. Abnormal prion protein (PrPSc) removal and infectivity of the samples was determined.ResultsS/D treatment and nanofiltration inactivated/removed enveloped viruses to below detection limits. IEC supplements viral safety and nanofiltration was highly effective in removing non-enveloped viruses and HAS 263K. Overall virus reduction factors were: ≥9.4 log10 (HIV-1), ≥13.2 log10 (PRV), ≥8.2 log10 (BVDV), ≥11.7 log10 (MEV), ≥11.6 log10 (PPV), and ≥10.4 log10 (HAS 263K).ConclusionTwo dedicated and one supplementing steps in the manufacturing process of the new IVIG 10% liquid provide a high margin of pathogen safety.

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“…This is the common logarithm (with base 10) of the ratio of the amount of virus and/or infectivity before and after a processing step. Log reduction factors are usually assessed by spiking studies 5‐8 …”

Section: Methodsmentioning

confidence: 99%

A probabilistic model for analyzing viral risks of plasma‐derived medicinal products

et al. 2007

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BACKGROUND:The prevention of transmission of viral infections by plasma-derived medicinal products is of concern to manufacturers, legislators, and patient representative groups. Recent European legislation requires a viral risk assessment for all new marketing applications of such products. STUDY DESIGN AND METHODS:A discrete event Monte Carlo model was developed to determine the viral transmission risks of the plasma-derived medicinal products. The model incorporates donor epidemiology, donation intervals, efficiency of screening tests for viral markers, inventory hold period, size and composition of the manufacturing pool, production time, process virus reduction capacity, and product yield. With the model, the human immunodeficiency virus (HIV) and hepatitis C virus (HCV) contamination risks of a typical hypothetical plasma product were calculated, and the sensitivity of the risk to various model variables was analyzed. RESULTS:The residual HIV and HCV risks of the finished products are linear in change with viral incidence rate and inversely linear with product yield and process virus reduction capacity. For the product analyzed in this article, the residual risk is less sensitive to changes in screening test pool size, donation frequency, and inventory hold period. There is only a limited dependency on the donation type (apheresis or whole-blood donations) and a negligible dependency on the manufacturing pool size. CONCLUSIONS:The use of probabilistic model simulation techniques is indispensable when estimating realistic residual viral risks of plasma-derived medicinal products. In contrast to conventional deterministic residual risk estimations, the probabilistic approach allows incorporation of specific manufacturing decisions and therefore provides the only feasible alternative for a correct assessment of residual risks.

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

Cited by 33 publications

References 32 publications

Anti‐SSA antibodies are present in immunoglobulin preparations

Anti‐SSA antibodies are present in immunoglobulin preparations

Pathogen Safety of a New Intravenous Immune Globulin 10% Liquid

A probabilistic model for analyzing viral risks of plasma‐derived medicinal products

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