A global standard for anti‐D immunoglobulin: international collaborative study to evaluate a candidate preparation

Thorpe, Susan J.; Sands, Dawn; Fox, Bernard; Behr-Gross, Marie-Emmanuelle; Schäffner, G; Yu, Meng-Lin

doi:10.1111/j.0042-9007.2003.00367.x

Cited by 11 publications

(11 citation statements)

References 9 publications

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“…For all samples, the geometric mean potency estimates by the cEIA and flow cytometry assays are similar. However, in most cases, the AutoAnalyser assays gave higher estimates than the other two Ph Eur methods and this is in agreement with the finding of the previous study when using the 2nd IS as the reference. Nevertheless, the data presented in Table show there is little difference between the overall potency estimate for samples A‐D when comparing the cEIA plus Flow Cytometry alone to all methods.…”

Section: Resultssupporting

confidence: 91%

The third international standard for anti‐D immunoglobulin: international collaborative study to evaluate candidate preparations

et al. 2019

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Background and Objectives The purpose of the study was to evaluate a lyophilized anti‐D immunoglobulin preparation to serve as a replacement WHO International Standard for the calibration of potency assays of anti‐D immunoglobulin products. Such products are used to prevent haemolytic disease of the foetus and newborn due to maternal alloanti‐D. Materials and Methods The candidate 3rd International Standard for anti‐D immunoglobulin (16/332) was evaluated and calibrated against the 2nd International Standard for anti‐D immunoglobulin (01/572), along with a coded duplicate, a second candidate preparation (16/278) and a comparability sample (16/272) in an international collaborative study. Twenty of 21 laboratories in 15 countries performed one or more of the three European Pharmacopoeia reference methods. Results The overall geometric mean potency (from all methods) of the candidate 3rd International Standard, 16/332, was 296·6 IU/ampoule, with inter‐laboratory variability, expressed as % GCV, of 4·7%. SE‐HPLC of the immunoglobulin preparations demonstrated combined monomeric and dimeric IgG peak areas of >95% for all samples. Accelerated stability studies have shown both 16/332 and 16/278 to be very stable for long‐term storage at −20°C. Conclusions Preparation 16/332 was established by the World Health Organisation Expert Committee on Biological Standardization as the 3rd International Standard for anti‐D immunoglobulin with an assigned potency of 297 IU/ampoule.

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Section: Resultssupporting

confidence: 91%

The third international standard for anti‐D immunoglobulin: international collaborative study to evaluate candidate preparations

et al. 2019

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“…In addition, we analyzed various HID immunization variables with respect to their glycosylation patterns. In view of the strong effect of Fc‐fucosylation on RBC clearing potency of RhIG, we investigated the fucose content of RhIG preparations from different suppliers as this may have great impact on the efficacy of these different preparations …”

mentioning

confidence: 99%

Prophylactic anti‐D preparations display variable decreases in Fc‐fucosylation of anti‐D

et al. 2014

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RhIG preparations vary in Fc-fucosylation and all demonstrate increased galactosylation. Despite not knowing the exact working mechanism, immunoprophylaxis could perhaps be optimized by selection of donors whose anti-D have low amounts of Fc-fucose, to increase the clearance activity of anti-D preparations, as well as high amounts of galactosylation, for anti-inflammatory effects. Implementing a biologic assay in the standardization of RhIG preparations might be considered.

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“…The anti-HPA-1a content, total protein content, IgG purity, non-detectable IgA presence in the final product are close to, or even exceeds, that of therapeutic anti-RhD preparations. Licensed anti-RhD product have an anti-D immunoglobulin content in the range of 625–750 IU/mL, a protein content close to 30 mg/mL, an IgG purity of 95–99%, an IgA content of 0.05% or less, and are complying with the European pharmacopoeia monograph for human anti-D immunoglobulins [ 48 , 49 ].…”

Section: Discussionmentioning

confidence: 99%

Anti-Human Platelet Antigen-1a Immunoglobulin G Preparation Intended to Prevent Fetal and Neonatal Alloimmune Thrombocytopenia

et al. 2016

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Fetal and neonatal alloimmune thrombocytopenia (FNAIT) is a severe disease that is caused by maternal alloantibodies generated during pregnancy or at delivery as a result of incompatibility between maternal and fetal human platelet antigens (HPAs) inherited from the father. Antibody-mediated immune suppression using anti-HPA-1a immunoglobulins is thought to be able to prevent FNAIT caused by HPA-1a. A fractionation process to prepare anti-HPA-1a immunoglobulin (Ig) G (IgG) from human plasma was therefore developed. Anti-HPA-1a plasma was obtained from volunteer mothers who underwent alloimmunization against HPA-1a during a previous pregnancy. Plasma was cryoprecipitated and the supernatant treated with caprylic acid and solvent/detergent (S/D), purified by chromatography, nanofiltered, concentrated, and sterile-filtered. The anti-HPA-1a immunoglobulin fraction was characterized for purity and safety. PAK12 and quantitative monoclonal antibody immobilization of platelet antigen (MAIPA) assays were used to detect anti-HPA-1a IgG. Hepatitis C virus (HCV) removal during nanofiltration was assessed by spiking experiments, using cell culture-derived reporter HCV and luciferase analysis. The caprylic acid treatment precipitated non-Ig proteins yielding a 90% pure Ig supernatant. S-HyperCel chromatography of the S/D-treated supernatant followed by HyperCel STAR AX provided high IgG recovery (>80%) and purity (>99.5%), and efficient IgA and IgM removal. Concentrations of complement factors C3 and C4 were < 0.5 and < 0.4 mg/dL, respectively. The final IgG could be nanofiltered on Planova 20N under conditions removing more than 3 log HCV infectivity to baseline mock infection level, and concentrated to ca. 30 g/L. Proteolytic activity and thrombin generation were low in the final fraction. The Pak12 and MAIPA assays showed good recovery of anti-HPA-1a throughout the process. Clinical-grade HPA-1a IgG can be prepared using a process compliant with current quality requirements opening perspectives for the prevention of FNAIT.

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A global standard for anti‐D immunoglobulin: international collaborative study to evaluate a candidate preparation

Cited by 11 publications

References 9 publications

The third international standard for anti‐D immunoglobulin: international collaborative study to evaluate candidate preparations

The third international standard for anti‐D immunoglobulin: international collaborative study to evaluate candidate preparations

Prophylactic anti‐D preparations display variable decreases in Fc‐fucosylation of anti‐D

Anti-Human Platelet Antigen-1a Immunoglobulin G Preparation Intended to Prevent Fetal and Neonatal Alloimmune Thrombocytopenia

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