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1.
Plasma-derived intravenous immunoglobulin (IVIG) preparations have been successfully applied for the prophylactic prevention of infectious diseases in immunodeficient patients. In addition to its replacement therapy of primary and secondary antibody deficiencies, IVIG has found increased use in autoimmune and inflammatory diseases. IVIG has become the major plasma product on the global blood product market. The world wide consumption nearly tripled between 1992 and 2003, from 19.4 to 52.6 tons. Classical manufacturing processes of IVIG, but also new strategies for purification are discussed with respect to practicability and yield. Ethanol fractionation is still the basis for most IVIG processes, although isolation and purification of immunoglobulin G (IgG) by chromatography has gained ground. The efficiency of virus inactivation methods and virus removal techniques in terms of logarithmic reduction factors are analyzed, but also the IgG losses are taken into consideration. Some of these methods also have the ability to separate prions. High pathogen safety and high yields have become the dominant goals of the plasma fractionation industry. 相似文献
2.
Indices of anti‐dengue immunoglobulin G subclasses in adult Mexican patients with febrile and hemorrhagic dengue in the acute phase
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Araceli Posadas‐Mondragón José Leopoldo Aguilar‐Faisal Adolfo Chávez‐Negrete Edith Guillén‐Salomón Verónica Alcántara‐Farfán Lucero Luna‐Rojas Amanda Marineth Ávila‐Trejo Judith del Carmen Pacheco‐Yépez 《Microbiology and immunology》2017,61(10):433-441
3.
Newcombe C Newcombe AR 《Journal of chromatography. B, Analytical technologies in the biomedical and life sciences》2007,848(1):2-7
Antibody based therapies using monoclonal or polyclonal antibodies are emerging as an important therapeutic approach for the treatment of a number of diseases. With increasing emphasis on new technologies associated with monoclonal antibody expression and purification, the clinical need of polyclonal therapeutics for treatment of a variety of specific illnesses and infections is often overlooked. Despite being largely abandoned in the early twentieth century due to the development of antibiotics, polyclonal antibody therapeutics are today widely used in medicine for viral and toxin neutralization and for replacement therapy in patients with immunoglobulin deficiencies. Over the past 20 years, intravenous immunoglobulins have shown beneficial immunomodulatory and anti-inflammatory effects in many illnesses. Hyperimmune antibody preparations have been used over the past century for the treatment of a variety of infectious agents and medical emergencies, including digoxin toxicity, snake envenomation and spider bites. Here, we examine the contemporary techniques and applications, and assess the future therapeutic potential, for polyclonal-derived antibody therapeutics. 相似文献
4.
Six patients suffering from recurrent chest infections were found to lack antibodies to a pooled antigen obtained from six different serotypes of commensal Escherichia coli bacteria. All had normal serum IgG concentrations, but five subsequently benefited from regular gammaglobulin injections. We suggest that the absence of such E. coli antibodies usually indicates a clinically significant defect in antibody production. This simple screening test is of use in the diagnosis of primary and secondary immunodeficiency disorders. 相似文献
5.
K M O'Neil H D Ochs S R Heller L C Cork J M Morris J A Winkelstein 《Journal of immunology (Baltimore, Md. : 1950)》1988,140(6):1939-1945
Previous studies have shown that animals pharmacologically depleted of C3 have impaired antibody responses. However, such C depletion is neither complete nor sustained, and the C3 cleavage products generated by C3 depletion can both enhance and inhibit the immune response. To clarify the role of C3 in humoral immunity, the antibody response of dogs with genetically determined total deficiency of C3 (C3D) was examined. Serum IgG levels of the C3D animals were within the normal range, but were significantly lower than levels seen in normal controls or C3D heterozygotes. Specific antibody production was defective: the antibody titers of C3D dogs in response to primary intravenous immunization with two different T cell-dependent Ag (sheep E and bacteriophage phi X-174) were markedly reduced when compared to either normal controls or C3D heterozygotes. After secondary immunization with T-dependent Ag, the total antibody titers were normal, but the C3D dogs made proportionately more IgM and less IgG antibody than did either control group. After i.v. immunization with a T cell-independent Ag (DNP-Ficoll), the C3D dogs had reduced levels of IgM and IgG antibody after primary and secondary immunization. Neither i.m. immunization nor the use of a 20-fold increase in Ag dose i.v. could correct the defect seen in the antibody response of C3D dogs. The results herein demonstrate that C3 plays a critical role in the generation of a normal humoral immune response. 相似文献
6.
Ch L Vasilev K V Veleva R Kh Tekelieva P I Pencheva 《Zhurnal mikrobiologii, epidemiologii, i immunobiologii》1991,(2):54-56
The antibody levels in 18 batches of the preparations of human immunoglobulin, Immunovenin and Immunovenin-Intact, for intravenous injection were determined in the enzyme immunoassay with the use of the mixture of P. aeruginosa lipopolysaccharide antigens of seven immunotypes. The average antibody titers in these preparations were identical. The preparations were found to have protective action against P. aeruginosa experimental infection in mice. 相似文献
7.
In order to minimize possible adverse reactions, the functional integrity of proteins in products derived from human plasma has to be unaffected by methods of preparation and storage conditions. Numerous biologically relevant functions of IgG, a major component of immunoglobulin for intravenous use preparations (IVIG), rely on the integrity of Fc fragments. Manufacturers are obliged to prove that Fc-mediated functions are maintained in IVIG preparations. The European Pharmacopoeia's monograph proposes a Rubella antigen-based test for Fc function of immunoglobulins. We present a modification of the proposed method achieved by using more convenient and readily available tetanus toxoid as an alternative antigen target and by adapting the procedure for the use on microtitre plates, thus greatly enhancing its feasibility and sample throughput. The test conditions were optimized so that batch-to-batch variability in tetanus antibody content did not influence the result. The precision of the test was within +/- 5%. By using this test, we compared Fc functionality of 9 commercial IVIG-7S preparations, which were prepared by using different virus inactivation/removal approaches. No significant differences between them have been found. 相似文献
8.
Serum levels of IgM, IgA, IgG1, IgG2a, IgG2b, and IgG3 were measured weekly for 8 weeks by radial immunodiffusion in pooled sera from female BALB/c and BDF1 mice with primary and secondary Taenia crassiceps infections and age-matched normal control mice of each strain. Although increases in levels of all immunoglobulin classes occurred during primary and secondary infections in both strains of mice, the only consistent changes common to both strains of mice were higher levels of IgG1 and IgG3 in early weeks of secondary infections as compared to primary infections, and high levels of IgG1 late in primary infections. High levels of IgG3 occurred late in primary infections in BDF1 mice but not in BALB/c mice. It was not possible to correlate increased levels of any one immunoglobulin class either with cytotoxic activity of early immune serum or with the onset of the cellular encapsulation response in secondary infections. IgM, IgA, IgG1, IgG2a, IgG2b, and IgG3 could be demonstrated on the surface of washed fixed larvae from long-term infected donor mice by the indirect fluorescent antibody method. Living T. crassiceps larvae were capable of shedding fluorescent label within 1 hr at room temperature, but not at 4 C after staining with either rabbit anti-T. crassiceps serum or rabbit anti-mouse immunoglobulin serum and fluorescein-conjugated goat anti-rabbit globulin. 相似文献
9.
Andreas Puschnik Louis Lau Elizabeth A. Cromwell Angel Balmaseda Simona Zompi Eva Harris 《PLoS neglected tropical diseases》2013,7(6)
Although heterotypic secondary infection with dengue virus (DENV) is associated with severe disease, the majority of secondary infections are mild or asymptomatic. The mechanisms of antibody-mediated protection are poorly understood. In 2010, 108 DENV3-positive cases were enrolled in a pediatric hospital-based study in Managua, Nicaragua, with 61 primary and 47 secondary infections. We analyzed DENV-specific neutralization titers (NT50), IgM and IgG avidity, and antibody titer in serum samples collected during acute and convalescent phases and 3, 6, and 18 months post-infection. NT50 titers peaked at convalescence and decreased thereafter. IgG avidity to DENV3 significantly increased between convalescent and 3-month time-points in primary DENV infections and between the acute and convalescent phase in secondary DENV infections. While avidity to DENV2, a likely previous infecting serotype, was initially higher than avidity to DENV3 in secondary DENV infections, the opposite relation was observed 3–18 months post-infection. We found significant correlations between IgM avidity and NT50 in acute primary cases and between IgG avidity and NT50 in secondary DENV infections. In summary, our findings indicate that IgM antibodies likely play a role in early control of DENV infections. IgG serum avidity to DENV, analyzed for the first time in longitudinal samples, switches from targeting mainly cross-reactive serotype(s) to the current infecting serotype over time. Finally, serum avidity correlates with neutralization capacity. 相似文献
10.
N Lahmann 《Folia haematologica (Leipzig, Germany : 1928)》1986,113(5):587-595
The supply of human immunoglobulin preparations (Ig) is steadily increasing. On the one hand, the wide range of specificities of the so-called hyper-Ig is broadening, on the other hand, the structural variety of Ig contained in the preparations and their fragments is increasing (intact IgG, Fab, F(ab')2 fragments, desaggregation, inactivation of the complement binding site). Specificity and structure of Ig are important for the efficacy, kind of application, amount and intervals of dosage and for compatibility. Therefore, an exact knowledge of the preparation becomes more and more necessary for reasonably applying it. The development of modern IgG preparations with intravenous compatibility and intact Fc-part providing the possibility for the application of a high dosage require "old" indications to be re-examined by clinically controlled investigations, thus opening new ways to an improved efficacy in applying Ig in the prophylaxis and therapy of infections as well as to new areas of indication by recognising the immunomodulatory effects, e.g. autoimmunopathies. 相似文献
11.
To clarify the humoral immunity in herpes simplex virus (HSV) infection, HSV-specific IgM, IgA and IgG subclass antibody responses were studied in patients with genital herpes: 17 primary, 13 recurrent and 6 nonprimary first episode. A total of 181 serum samples serially collected from the patients, 5 per patient until 213 days after the onset of disease (on average), were analyzed by an enzyme-linked immunosorbent assay. IgGl, IgG3 and IgA were detected in all patients with primary and nonprimary infections, whereas IgG4 was detected in 74% of only those with nonprimary infections and IgG2 was detected in none. IgM was detected in 100% of the patients with primary infections, but also in 68% of those with nonprimary infections. IgA showed a peak similar to that of IgM in patients with primary infections. No significant difference was observed in the detection rate or pattern of antibody responses between the recurrent and nonprimary first episode infections, nor between the HSV-1 and HSV-2 infections. These findings may be useful to improve the diagnostic potential of HSV serology. 相似文献
12.
It is shown that diffraction-based sensing can be enhanced for diagnostic purposes through the use of a secondary label. The limit of detection for anti-rabbit IgG was reduced more than 40-fold by using a gold-conjugated secondary antibody. The response to secondary antibody binding was linear for concentrations from 25 to 500 ng/ml of anti-rabbit IgG, suggesting that quantitative determinations can be readily done. Moreover, the binding of the secondary antibody was observed as soon as 1 min after its introduction to the surface-bound primary complex. 相似文献
13.
Li Y Ohms SJ Shannon FM Sun C Fan JY 《Biochemical and biophysical research communications》2012,418(4):748-753
High-dose intravenous immunoglobulin (IVIG) preparations are currently used for the treatment of autoimmune diseases such as immune thrombocytopenic purpura (ITP). Although the mechanisms of IVIG efficacy remain enigmatic, some clinical and laboratory studies suggest that interaction of the Fc domain of IgG, especially the Fc domain of dimeric IgG, with its receptors (Fc gamma receptors; FcγRs) plays an essential role. In this study, IVIG was dimerized with chemical crosslinkers to augment its therapeutic efficacy. Dimerized IVIG was found to have a much higher affinity for FcγRs than monomeric IVIG. In a mouse ITP model, chemically dimerized IVIG abrogated the decrease in platelet numbers in the blood that was caused by an anti-platelet antibody at a dose that was one tenth of the required dose of IVIG. These results suggest that chemical dimerization of IVIG should greatly improve the efficacy of IVIG therapy of ITP. 相似文献
14.
Bryan Smith Rocio Lledo-Garcia Kate L. Dixon Louis Christodoulou Matthew C. Catley 《MABS-AUSTIN》2018,10(7):1111-1130
Rozanolixizumab (UCB7665), a humanized high-affinity anti-human neonatal Fc receptor (FcRn) monoclonal antibody (IgG4P), has been developed to reduce pathogenic IgG in autoimmune and alloimmune diseases. We document the antibody isolation and compare rozanolixizumab with the same variable region expressed in various mono-, bi- and trivalent formats. We report activity data for rozanolixizumab and the different molecular formats in human cells, FcRn-transgenic mice, and cynomolgus monkeys. Rozanolixizumab, considered the most effective molecular format, dose-dependently and selectively reduced plasma IgG concentrations in an FcRn-transgenic mouse model (no effect on albumin). Intravenous (IV) rozanolixizumab dosing in cynomolgus monkeys demonstrated non-linear pharmacokinetics indicative of target-mediated drug disposition; single IV rozanolixizumab doses (30 mg/kg) in cynomolgus monkeys reduced plasma IgG concentration by 69% by Day 7 post-administration. Daily IV administration of rozanolixizumab (initial 30 mg/kg loading dose; 5 mg/kg daily thereafter) reduced plasma IgG concentrations in all cynomolgus monkeys, with low concentrations maintained throughout the treatment period (42 days). In a 13-week toxicology study in cynomolgus monkeys, supra-pharmacological subcutaneous and IV doses of rozanolixizumab (≤ 150 mg/kg every 3 days) were well tolerated, inducing sustained (but reversible) reductions in IgG concentrations by up to 85%, with no adverse events observed. We have demonstrated accelerated natural catabolism of IgG through inhibition of IgG:FcRn interactions in mice and cynomolgus monkeys. Inhibition of FcRn with rozanolixizumab may provide a novel therapeutic approach to reduce pathogenic IgG in human autoimmune disease. Rozanolixizumab is being investigated in patients with immune thrombocytopenia (NCT02718716) and myasthenia gravis (NCT03052751). 相似文献
15.
Diego S. Ojeda María Mora Gonzalez Lopez Ledesma Horacio M. Pallars Guadalupe S. Costa Navarro Lautaro Sanchez Beatriz Perazzi Sergio M. Villordo Diego E. Alvarez BioBanco Working Group Marcela Echavarria Kasopefoluwa Y. Oguntuyo Christian S. Stevens Benhur Lee Jorge Carradori Julio J. Caramelo Marcelo J. Yanovsky Andrea V. Gamarnik 《PLoS pathogens》2021,17(1)
We report the emergency development and application of a robust serologic test to evaluate acute and convalescent antibody responses to SARS-CoV-2 in Argentina. The assays, COVIDAR IgG and IgM, which were produced and provided for free to health authorities, private and public health institutions and nursing homes, use a combination of a trimer stabilized spike protein and the receptor binding domain (RBD) in a single enzyme-linked immunosorbent assay (ELISA) plate. Over half million tests have already been distributed to detect and quantify antibodies for multiple purposes, including assessment of immune responses in hospitalized patients and large seroprevalence studies in neighborhoods, slums and health care workers, which resulted in a powerful tool for asymptomatic detection and policy making in the country. Analysis of antibody levels and longitudinal studies of symptomatic and asymptomatic SARS-CoV-2 infections in over one thousand patient samples provided insightful information about IgM and IgG seroconversion time and kinetics, and IgM waning profiles. At least 35% of patients showed seroconversion within 7 days, and 95% within 45 days of symptoms onset, with simultaneous or close sequential IgM and IgG detection. Longitudinal studies of asymptomatic cases showed a wide range of antibody responses with median levels below those observed in symptomatic patients. Regarding convalescent plasma applications, a protocol was standardized for the assessment of end point IgG antibody titers with COVIDAR with more than 500 plasma donors. The protocol showed a positive correlation with neutralizing antibody titers, and was used for clinical trials and therapies across the country. Using this protocol, about 80% of convalescent donor plasmas were potentially suitable for therapies. Here, we demonstrate the importance of providing a robust and specific serologic assay for generating new information about antibody kinetics in infected individuals and mitigation policies to cope with pandemic needs. 相似文献
16.
Not significant differences in the composition or concentration of specific antibodies against microbial antigens could be measured in five commercially available human immunoglobulin preparations for intravenous use. Prediction of prophylactic or therapeutic efficiency of such preparations according to their antibody content seems to be only partially possible. Human immunoglobulins for intravenous use should be free from irregular antibodies against erythrocyte antigens of the Rh-systems, as found in one of the specimens tested. 相似文献
17.
L V Feklisova A I Pokatilova T M Iurina I A Kiseleva V N Shabalin 《Zhurnal mikrobiologii, epidemiologii, i immunobiologii》1991,(4):53-56
The data on the results of clinico-immunological examination of 46 infants having purulent inflammatory infections in the first month of their life and treated with (a) immunoglobulin for intravenous injection, (b) with hyperimmune antistaphylococcal plasma and immunoglobulin for intravenous injection and (c) without the use of specific hyperimmune preparations are presented. The clinico-laboratory data thus obtained (the levels of serum immunoglobulins and the content of T-rosette-forming lymphocytes) are indicative of the expediency of including the intravenous injection of donor immunoglobulin into the complex therapy of newborn infants with severe and moderate forms of purulent inflammatory infections at an early period of the disease irrespective of its etiology. 相似文献
18.
Common variable immunodeficiency (CVID) comprises a heterogeneous group of patients with as yet undefined genetic defects.
Patients with CVID have in common a decrease in the levels of one or more serum immunoglobulin isotypes and a severe defect
in the production of specific antibodies. Typically, the patients suffer from recurrent infections of the upper and lower
respiratory tract or the gastrointestinal tract. In consequence of these infections patients may develop severe organ damage,
such as chronic pulmonary disease with bronchiectases, leading to pulmonary failure. Early diagnosis of CVID is important,
as antibody deficiency can efficiently be treated by regular intravenous IgG (IVIG) substitution therapy. IVIG therapy prevents
the occurrence of further acute infectious episodes and the development of long-term complications. The basic immunological
defect(s) in patients with CVID are still unknown. There is currently no convincing evidence for an intrinsic B-cell defect
in patients with CVID. A defect in T-cell activation due to impaired signal transduction upon T-cell receptor triggering has
been described in a large subgroup of patients with CVID. Defective T-cell activation may lead to an impairment in cognate
T-B-cell interaction due to impaired expression of CD40 ligand and/or abnormalities in the production T-cell-derived cytokines
required for fully functional B-cell activation, proliferation and/or differentiation which could indeed explain the impairment
in antibody production present in CVID patients.
Dedicated to Professor J. Šterzl on the occasion of his 70th birthday 相似文献
19.
A four year old boy with symptoms of HIV infection and serum IgG of 53.2 g/l had been treated for 16 months with regular infusions of intravenous immunoglobulin (IV IgG). During one such infusion he developed temporary neurological symptoms and signs suggestive of the hyperviscosity syndrome. Serum relative viscosity was raised at 5.0 (normal range 0.42-2.78). Subsequent IV IgG infusions given at a slower rate have been without adverse reactions. In a study of eight HIV infected children including the index case, and 20 children not infected with HIV, serum relative viscosity was significantly raised in the HIV infected children (p less than 0.01; students t-test). Viscosity correlated with total serum IgG, which was raised in all HIV infected children, and with serum IgM. In HIV infected children with very high levels of serum IgG a slow rate of IV IgG infusion should therefore be chosen due to the possibility of hyperviscosity. 相似文献
20.
Disseminated cryptococcosis presenting as thyroiditis. Fine needle aspiration and autopsy findings 总被引:1,自引:0,他引:1
A 47-year-old diabetic ethanol and intravenous drug abuser presented with symptoms and signs indistinguishable from subacute thyroiditis. After cultures of cerebrospinal fluid grew Cryptococcus neoformans, the organism was recognized in a review of a fine needle aspirate of the thyroid. Postmortem examination documented extensive thyroid inflammation and fibrosis secondary to involvement by widely disseminated C. neoformans. Fungal infection is an uncommon cause of thyroiditis, and the need for a clinical awareness of fungal thyroiditis is emphasized, as is the need to utilize special stains to detect opportunistic infections when examining cytologic preparations from immunocompromised patients. 相似文献