Immunoglobulin preparations

Human immunoglobulin preparations from pools of a great number of people (>1,000) with assumed antibodies against common viruses are used as a means of passive immunization in acute infections. More specific antibody preparations with high titers from patients who recovered recently from a viral disease or were immunized against toxins are also available in... 

The immune globulins are contraindicated in patients with a history of allergic reactions after administration of human immunoglobulin preparations and individuals with isolated immunoglobulin A (IgA) deficiency (individuals could have an anaphylactic reaction to subsequent administration of blood products that contain IgA). 

Antibody preparations used to induce passive immunity may be obtained from either animal or human sources. Preparations of animal origin are generally termed antisera , and those sourced from humans are called immunoglobulin preparations . In both cases, the predominant antibody type present is IgG. 

Immunoglobulins are purified from the serum (or plasma) of human donors by methods similar to those used to purify animal-derived antibodies. In most instances, the immunoglobulin preparations are enriched in antibodies capable of binding to a specific antigen (usually an infectious mi-croorganism/virus). These may be purified from donated blood of individuals who have recently ... 

Although hypersensitivity reactions can occur upon administration of immunoglobulin preparations, the incidence of such events is far less frequent than is the case upon administration of antibody preparations of animal origin. As with all blood-derived products, the serum from which the immunoglobulins are due to be purified is first assayed for the presence of infectious agents before its use. 

Normal immunoglobulin preparations are purified from pooled material obtained from 1000 or more donors. They will generally contain antibodies against diphtheria, measles, poliomyelitis, hepatitis A, rubella and varicella. Normal immunoglobulin may, therefore, be used to provide passive immunization against these diseases. 

A quite different approach to immunomodulation is the intravenous use of polyclonal human immunoglobulin. This immunoglobulin preparation (usually IgG) is prepared from pools of thousands of healthy donors, and no specific antigen is the target of the "therapeutic antibody." Rather, one expects that the pool of different antibodies will have a normalizing effect upon the patient s immune networks. 

Editors Notes Effective at preventing CMV disease but more expensive than prophylactic ganciclovir. Immunoglobulin preparations have been shown to desensitize patients on the waiting list which allows transplantation. J- s o... 

Hypersensitivity to human immunoglobulin preparations Selective IgA deficiency... 

See the following references for an analysis of additional uses of intravenously administered immune globulin Ratko TA et al Recommendations for off-label use of intravenously administered immunoglobulin preparations. JAMA 1995 273 1865 and Dalakas MC Intravenous immune globulin therapy for neurologic diseases. Ann Intern Med 1997 126 721. 

Teeling JL, Jansen-Hendriks T, Kuijpers TW, de Haas M, van De Winkel JG, Hack CE, Bleeker WK. Therapeutic efficacy of intravenous immunoglobulin preparations depends on the immunoglobulin G dimers studies in experimental immune thrombocytopenia. Blood 2001 98 1095-9. 

Smith, G. J., McFarland, R. D., Reisner, H. M., and Hudson, G. S. (1984). Lymphoblastoid cell-produced immunoglobulins Preparative purification from culture medium by hydroxyl-apatite chromatography. Anal. Biochem. 141, 432-436. 

Labeling should be carried out on immunoglobulin preparations derived from the selected antisera, so as to maximize the proportion of specific antibody to total protein and hence reduce non-specific activity in the final reagent. Immunoglobulin can be prepared by any of the methods described above, but only in the most demanding systems will it be necessary to prepare immunospecific antibody rather than a crude immunoglobulin fraction. 

Fluorescein isothiocyanate, isomer I (FITC) Carbonate-bicarbonate buffer, 0.1 M, pH 9.0 Immunoglobulin preparation (10 mg/ml in saline) Phosphate-buffered saline, pH 7.5 (PBS) Sephadex G-50 medium... 

Passive immunity can be obtained by i.m. injection of globulin containing antibody to the virus normal immunoglobulin prepared from pooled plasma from known immune donors) which confers temporary protection for travellers visiting areas where the virus is endemic. Active immunisation with Hepatitis A vaccine is now preferable protective antibody takes about two weeks to develop. 

Blood products The use of blood units or blood products with haemophiliac patients as well as the administration of immunoglobulin preparations in general (322, 347) were accompanied by high HCV positivity. Today, there is only a slight risk of HCV infection in this respect. 

Friedli, H.R. Methodology and safety considerations in the production of an intravenous immunoglobulin preparation. Pharmacotherapy 1987, 7 (Suppl), 36S-40S. 

Immunoglobulin preparations are concentrated protein solutions derived from the pooled plasma of adults or animals. They contain specific antibodies in proportion to the infectious and immunization experience of the population from whose plasma they are prepared (1). Large numbers of donors (at least 1000 donors per lot of final product) are used, in order to ensure inclusion of a broad spectrum of antibodies. Intravenous immunoglobulin is also derived from the pooled plasma of adults, but the alcohol-fractionation procedure is modified to a product suitable for intravenous use. The use of intravenous immunoglobulins in selected immunodeficiency and autoimmune diseases has been reviewed (2). 

Specific immunoglobulins, termed hyperimmune globulins, are derived from human donors known to have high titers of the desired antibody. Specific immunoglobulin preparations for use in infectious disease prevention include hepatitis B, rabies, tetanus. Varicella zoster, vaccinia, and cytomegalovirus immunoglobulin. 

The transmission of viral infections by immunoglobulins has occasionally been suspected. However, intravenous immunoglobulin preparations are considered relatively safe, and there are no reports of transmission of HIV or hepatitis B (44,101). This is probably because of the high degree of viral inactivation of the cold ethanol fractionation and the screening of every donation for several viruses, such as HIV and hepatitis B and C (85). Of 56 patients with autoimmune diseases who received 167 infusions of intravenous immunoglobulin, none developed antibodies to human immunodeficiency virus and hepatitis C virus or hepatitis B surface antigen (12). 

Wolberg AS, Kon RH, Monroe DM, Hoffman M. Coagulation factor XI is a contaminant in intravenous immunoglobulin preparations. Am J Hematol 2000 65(l) 30-4. 

Turner CE, Thorpe SJ, Brasher MD, Thorpe R. Anti-Rh D activity of commercial intravenous immunoglobulin preparations. Vox Sang 1999 76(l) 55-8. 

Intravenous immunoglobulin preparations. University Health System Consortium, 1999 Mar (216... 

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