Abstract:
BACKGROUND:The production of house dust mite (HDM) allergen products for allergy immunotherapy has traditionally been based on purified mite bodies or whole-mite culture, which are quite different source materials with a limited possibility for adjusting the chemical composition. The SQ HDM SLIT-tablet is a fast-dissolving pharmaceutical formulation that has been developed for sublingual immunotherapy (SLIT) of HDM respiratory allergic disease. OBJECTIVE:The objective of the present study was to establish a process for the production of drug substances for the SQ HDM SLIT-tablet offering a high reproducibility and independent control of the major allergens. METHODS:Process controls were documented in a comprehensive process parameter qualification. The analyses comprised composition by crossed immunoelectrophoresis, protein content by BCA, total IgE binding potency by Centaur assay, quantitative major allergen determination by radial immunodiffusion and ELISA, and the ranking of emPAI scores generated by mass spectrometry. RESULTS:Analysis of 20 batches of final product yielded a normalized mean and standard deviation for IgE binding potency of 100 ± 4.5. The standard deviation in the contents of Der f 1 and Der p 1 were correspondingly 11.9 and 6.1, whereas the variation in the group 2 major allergen content was 6.4. All measured 95% confidence limits between batches were less than 12%. CONCLUSIONS:The production process for the SQ HDM SLIT-tablet based on the separation of source material into four fractions each enriched in one major allergen enables precise adjustment of the relative major allergen content and high reproducibility of the final product.
journal_name
Int Arch Allergy Immunoljournal_title
International archives of allergy and immunologyauthors
Henmar H,Frisenette SM,Grosch K,Nielsen K,Smith G,Sønderkær S,Larsen JNdoi
10.1159/000444016subject
Has Abstractpub_date
2016-01-01 00:00:00pages
23-32issue
1eissn
1018-2438issn
1423-0097pii
000444016journal_volume
169pub_type
杂志文章abstract::IgE is a key mediator in allergic diseases. However, in strong contrast to other antibody isotypes, many details of the composition of the human IgE repertoire are poorly defined. The low levels of human IgE in the circulation and the rarity of IgE-producing B cells are important reasons for this lack of knowledge. In...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章,评审
doi:10.1159/000355947
更新日期:2014-01-01 00:00:00
abstract::In all mammalian species investigated so far, mast cells and basophils are the only cells that synthesize histamine and express plasma membrane receptors that bind IgE with high affinity (Fc epsilonRI). Human basophils and mast cells derive from distinct precursors that originate in the bone marrow and fetal liver and...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章,评审
doi:10.1159/000237670
更新日期:1997-11-01 00:00:00
abstract::Der f2 protein in a highly antigenic form was directly expressed in bacteria. Plasmid pFLU11 derived from pKK233-2 was designed to express methionyl-Der f2 under the control of the trc promoter and it has the replication origin of pUC118 instead of its original to increase the copy number. This expression plasmid dire...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000237263
更新日期:1996-04-01 00:00:00
abstract::Increased serum IgE and enhanced susceptibility to viral infections, decreased levels of interferons, lymphocytic skin infiltrates and IgE-bearing epidermal Langerhans cells are striking features in patients with atopic eczema (AE). Since the hyper-IgE syndrome is known to improve under alpha-interferon (alpha-IFN) th...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000236494
更新日期:1993-01-01 00:00:00
abstract:BACKGROUND:Jellyfish stings cause painful, papular-urticarial eruptions due to the immediate allergic, acute toxic and persistent inflammatory responses. In spite of many marine accidents and their economic impact, modes of first-aid treatment remain conventional and specific allergen and medical treatment are not yet ...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000434721
更新日期:2015-01-01 00:00:00
abstract:BACKGROUND:Atopic dermatitis (AD) is increasing among the elderly. Staphylococcus aureus colonization is one of the most important aggravating factors in AD. OBJECTIVE:This study analyses the clinical features of AD in elderly patients and determines the pathogenic roles of staphylococcal superantigens in AD with low ...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000329150
更新日期:2012-01-01 00:00:00
abstract::Recently, the induction of T cell anergy has been considered as a sophisticated form of immunotherapy. However, the multiplicity of T cell allergen epitopes discourages the practical use of this method. Since orally administered antigen proteins are digested to peptides and absorbed into the circulation, oral administ...
journal_title:International archives of allergy and immunology
pub_type: 临床试验,杂志文章
doi:10.1159/000237002
更新日期:1995-05-01 00:00:00
abstract:BACKGROUND:A number of different molecules are known to be involved in the signal pathway to release histamine from mast cells, among which arachidonic acid (AA) is one of the key mediators. On the other hand, we found that the application of compound 48/80, a typical histamine liberator, generated superoxide in mast c...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000070216
更新日期:2003-04-01 00:00:00
abstract:BACKGROUND:Although common variable immunodeficiency (CVID) is associated with sinopulmonary disease, there are no previous systematic evaluations comparing computed tomographic (CT) sinus imaging with immunoglobulin measurements in patients with this condition. METHODS:We performed a retrospective review by a blinded...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000260088
更新日期:2010-01-01 00:00:00
abstract:BACKGROUND:Wheat is known as the most widely consumed food all over the world. Although many types of wheat allergy have been recognized, their treatment still has a long way to go due to the complex pathogenesis. Oral immunotherapy (OIT) is under investigation for the treatment of wheat allergies. Previous studies hav...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000506945
更新日期:2020-01-01 00:00:00
abstract::Red soft coral (RSC; Dendronephthya nipponica, a marine coelenterate) causes spiny lobster fishermen living along the Pacific coast of Miyazaki Prefecture in Japan to develop occupational allergies, such as conjunctivitis, rhinitis, dermatitis and bronchial asthma. The aim of this study was to purify and to characteri...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000053807
更新日期:2001-06-01 00:00:00
abstract:BACKGROUND:Allergic conjunctivitis is characterized by itchy, watery and swollen eyes which occur in response to exposure to seasonal or environmental allergens. The early phase reaction of allergic conjunctivitis is primarily mediated by mast cell degranulation while the late phase reaction is driven by Th2 cells and ...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000328769
更新日期:2012-01-01 00:00:00
abstract::To assess the role of infection in anti-DNA antibody production, the DNA-binding activity of sera from patients with Escherichia coli bacteremia was analyzed. Among 8 patients with bacteremia documented by blood culture, 5 demonstrated increased levels of antibodies to single-stranded DNA from E. coli as measured by e...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000236204
更新日期:1992-01-01 00:00:00
abstract:BACKGROUND:Exposure and sensitization to indoor allergens have been associated with the development of asthma and other allergic diseases in many parts of the world. It is important to establish the degree of exposure, and to evaluate whether allergen control measures are effective in a particular area. METHODS:Concen...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000077356
更新日期:2004-04-01 00:00:00
abstract::Antibodies to specific autoantigens are serological hallmarks of systemic autoimmune diseases. These autoantibodies are thought to represent a consequence of immune dysregulation in these conditions, and, in part, have been shown to be involved in their pathologic consequences. However, the mechanisms that lead to the...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章,评审
doi:10.1159/000024422
更新日期:2000-09-01 00:00:00
abstract::A significant increase in the incidence of allergy and asthma has been observed during the past decades. The background of this phenomenon has not been well explained, but changes in lifestyle and habits are heavily discussed as contributing factors. Among these is a too clean environment, which may predispose individ...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章,评审
doi:10.1159/000329137
更新日期:2012-01-01 00:00:00
abstract:BACKGROUND:Five to twenty percent of healthy, nonasthmatic individuals exhibit airway hyperreactivity. Because cytokines are important intermediates in airway responses, we investigated the relationship between serum cytokines and airway responsiveness in a well-characterized population of pregnant women. METHODS:We a...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000069008
更新日期:2003-02-01 00:00:00
abstract::Asthmatic individuals in the general population appear to be susceptible to disease exacerbation during summertime 'smog' episodes (ambient air pollution containing other pollutants in addition to ozone). Although controlled exposure to ozone causes acute decrements in lung function, asthmatic subjects are only margin...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章,评审
doi:10.1159/000236989
更新日期:1995-05-01 00:00:00
abstract:BACKGROUND:Hymenoptera venom allergy (HVA) has a prevalence of 3% in adults. Although patients have no ongoing symptoms, they often suffer from an impairment of their psychological well-being and quality of life. OBJECTIVE:The aim of this study was to analyze sex-specific differences regarding the psychological burden...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000507625
更新日期:2020-01-01 00:00:00
abstract:BACKGROUND:The fractional concentration of exhaled nitric oxide (FeNO) is a surrogate biomarker for Th2-dependent bronchial inflammation. The present study investigated whether FeNO may characterize allergic rhinitis (AR) patients. METHODS:A total of 553 AR patients (497 males, mean age 28.8 years) were evaluated. Tho...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000456548
更新日期:2017-01-01 00:00:00
abstract:BACKGROUND:Fusion proteins assembling multiple allergens can be engineered by recombinant DNA technologies in order to produce tools for diagnostic and immunotherapeutic purposes. Herein, we developed and characterized chimeras assembling Der p 1 and Der p 2 allergens as potential candidate vaccines against house dust ...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000312631
更新日期:2010-01-01 00:00:00
abstract:BACKGROUND:Characterization of seafood allergens is important to understand the immune response to these allergens. Moreover, a detailed comparison between atopic and nonatopic patients with adverse reactions to shrimp has never been reported. METHODS:Raw and boiled shrimp extracts were analyzed by immunoblotting usin...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000076828
更新日期:2004-03-01 00:00:00
abstract:BACKGROUND:The hemagglutinin (HA) of influenza viruses is one of the major targets of the humoral response. The role of serum antibody to HA in the protection against infection has been demonstrated by long-standing observation. In previous studies, we suggested that an epitope vaccine might be a new strategy against t...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000053869
更新日期:2002-03-01 00:00:00
abstract::HIV-1 RNA has become the standard for monitoring antiretroviral therapies. Dogma predicts, however, that a viral protein like p24 should be at least as good a marker of HIV disease activity, provided that it is measured with sufficient sensitivity and accuracy. Simple modifications including use of a more efficient vi...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章,评审
doi:10.1159/000074552
更新日期:2003-11-01 00:00:00
abstract:BACKGROUND:Prostaglandin D(2) (PGD(2)), a major prostanoid produced by activated mast cells, has long been implicated in allergic diseases. PGD(2) demonstrates its effects through two G-protein-coupled receptors, DP and CRTH2. The PGD(2)/CRTH2 system mediates chemotaxis of eosinophils, basophils, and Th2 cells, which a...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000095436
更新日期:2006-01-01 00:00:00
abstract::The antigenic and allergenic characteristics of three bovine epithelial extracts, dander, skin scrapings and whole skin, were compared using IgE-ELISA inhibition and SDS-PAGE with immunoblotting. Cow dander extract was shown to contain more allergenic activity than skin scrapings or whole skin extracts which were need...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000236343
更新日期:1992-01-01 00:00:00
abstract::The perchloric-acid-soluble Bacille bilié de Calmette-Guérin (BCG) antigen (BCG-P) was investigated for the diagnosis of tuberculosis. Monoclonal antibodies against BCG-P were produced. After SDS-PAGE, silver staining and immunoblotting were done. Pathological specimens of pulmonary tuberculosis, BCG organism itself a...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000236476
更新日期:1993-01-01 00:00:00
abstract::Phosphoinositide 3-kinases (PI3Ks) are known to be involved in a variety of cellular responses such as cell survival, proliferation, differentiation and cell migration. Recently, PI3Ks have been associated with the pathogenesis of asthma because various immune cells regulate allergic responses. Among the three classes...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章,评审
doi:10.1159/000312132
更新日期:2010-01-01 00:00:00
abstract:BACKGROUND:We have previously shown that the allergic sensitization to ovalbumin does not represent a superantigen-like immune response. In gene-targeted mice (ΔD-iD) with a single modified Diversity gene segment (D(H)) of the immunoglobulin heavy chain, enriched for charged amino acids, the asthma phenotype in a murin...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000323527
更新日期:2011-01-01 00:00:00
abstract::Endogenous peroxidase has been reported in rat peritoneal mast cells and granules. Mast cell granules have also been shown to avidly bind exogenous eosinophil peroxidase. To examine the possibility that contaminating eosinophil peroxidase contributes to the reported rat mast cell peroxidase activity, mast cells were i...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000236655
更新日期:1994-01-01 00:00:00