ArticleBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2016
Reduction of Isoagglutinin in Intravenous Immunoglobulin (IVIG) Using Blood Group A- and B-Specific Immunoaffinity Chromatography: Industry-Scale Assessment.
Article in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
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Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.
- Incidence and risk factors for intravenous immunoglobulin-related hemolysis: A systematic review of clinical trial and real-world populations.Transfusion · 2022Pooled it
- Assessment of severity and mortality of COVID-19 with anti-A1 and anti-B IgM isohaemagglutinins, a reflection of the innate immune status.International journal of clinical practice · 2021Trial
- Efficacy and safety of IVIG in CIDP: Combined data of the PRIMA and PATH studies.Journal of the peripheral nervous system : JPNS · 2019Trial
- Polyclonal Antibody Therapeutics: Analytical Innovations and Regulatory Perspectives for Addressing Heterogeneity Challenges.Analytical chemistry · 2026Review
- Production and Quality Assurance of Human Polyclonal Hyperimmune Immunoglobulins Against SARS-CoV-2.Transfusion medicine reviews · 2022Article
- Expanding the Role of the Pharmacist: Immunoglobulin Therapy and Disease Management in Neuromuscular Disorders.Journal of pharmacy practice · 2022Review
- Intravenous immunoglobulin and the current risk of moderate and severe anaphylactic events, a cohort study.Clinical and experimental immunology · 2021Observational
- Process steps for the fractionation of immunoglobulin (Ig) G depleted of IgA, isoagglutinins, and devoid of in vitro thrombogenicity.Blood transfusion = Trasfusione del sangue · 2021Article
- Anti-A/B isoagglutinin reduction in an intravenous immunoglobulin product and risk of hemolytic anemia: a hospital-based cohort study.Transfusion · 2020Article
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- Impact of screening and exclusion of high anti-A titer donors on the risk of hemolytic anemia with intravenous immunoglobulin treatment: A hospital-based cohort study in the US.American journal of hematology · 2018Article
Corrections and comments
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Authors and funding
9 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHemolysis, a rare but potentially serious complication of intravenous immunoglobulin (IVIG) therapy, is associated with the presence of antibodies to blood groups A and B (isoagglutinins) in the IVIG product. An immunoaffinity chromatography (IAC) step in the production process could decrease isoagglutinin levels in IVIG.
objectivesOur objectives were to compare isoagglutinin levels in a large number of IVIG (Privigen
methodsThe IAC column comprised a blend of anti-A and anti-B resins formed by coupling synthetic blood group antigens (A/B-trisaccharides) to a base bead matrix, and was introduced towards the end of the industrial-scale IVIG manufacturing process. Isoagglutinin levels in IVIG were determined by anti-A and anti-B hemagglutinin direct and indirect methods according to the European Pharmacopoeia (Ph. Eur.) and an isoagglutinin flow cytometry assay. IVIG product quality was assessed with respect to the retention of immunoglobulin G (IgG) subclasses, specific antibodies, and removal of IgM using standardized procedures.
resultsThe IAC step reduced isoagglutinins in IVIG by two to three titer steps compared with lots produced without IAC. The median anti-A and anti-B titers with IAC were 1:8 and 1:4, respectively, when measured by the Ph. Eur. direct method, and 1:2 and <1, respectively, when measured by the Ph. Eur. indirect method. The isoagglutinin flow cytometry assay showed an 87-90 % reduction in isoagglutinins in post-IAC versus pre-IAC fractions. IAC alone reduced anti-A and anti-B of the IgMs isotype by 92.5-97.8 % and 95.4-99.2 %, respectively. Other product quality characteristics were similar with and without IAC.
conclusionsIAC is an effective method for reducing isoagglutinin levels in IVIG, and it is feasible on an industrial scale.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.