Abstract: The invention relates to method for quantification of the absolute amount of allergen in an allergen sample comprising: a) providing a known amount of one or more allergen calibration standard peptide(s) having a sequence of amino acids which is identical with, and optionally unique for, a sequence to be found in the allergen to be quantified and optionally labelling said allergen calibration standard peptide(s), b) degrading the allergen sample to obtain a mixture of peptides, and optionally labelling said peptides with one or more labelling agent(s), wherein at least the peptides in the degraded allergen sample or the calibration standard peptides are labelled, and if both the peptides in the degraded allergen sample and the allergen calibration standard peptide(s) are labelled, the labelling agent(s) used for labelling the allergen calibration standard peptide(s) are different from the labelling agent(s) used for labelling the peptides of the degraded allergen sample, c) quantifying the absolute amount of

Abstract: The present invention relates to a process for producing an allergen extract from a biological allergen source material comprising the steps of a) contacting the source material with a liquid extraction agent to produce a allergen extract mixture containing allergens dissolved in a liquid phase and a solid phase consisting of source material residues, b) subjecting the allergen extract mixture to a first separation step to remove the solid phase to produce a crude allergen extract, c) subjecting the crude allergen extract to a low molecular fraction removal step to remove molecules having a molecular size of less than 10 kDa, and d) carrying out step c) until the allergen extract has conductivity of below 2000 ?S/cm at 25° C. to obtain a purified allergen extract.

Abstract: The invention relates to a solid vaccine formulation adapted for mucosal administration comprising at least one antigen as active substance, wherein the formulation comprises a lyophilisate of a suspension comprising an oxygen-containing metal salt, the antigen(s) and one or more excipients selected from (i) saccharides, (ii) sugar alcohols, and (iii) amino acids or pharmaceutically acceptable salts thereof.

Abstract: The present invention relates to novel recombinant protein variants that are useful as immunotherapeutic components. Also the present invention relates to DNA sequences encoding said protein variants as well as compositions comprising said protein variants.

Abstract: The present invention relates to the field of dissolution measurement and, more particularly to methods for reproducible dissolution testing of pharmaceutical products such as allergen vaccines.

Abstract: The present invention pertains to a composition for the manufacture of a medicament comprising living or dead bacteria with controlled amounts of surface-coupled proteins or proteinaceous compounds and a method for the preparation of the composition. The bacterium provides a multivalent heterologous protein display vehicle that may be used in the manufacture of vaccines or medicaments for delivery via the mucosa.

Abstract: The invention provides allergen containing pharmaceutical products and in particular fast-dispersing solid allergen dosage forms. In particular, fast-dispersing, non-compressed solid dosage forms suitable for oromucosal administration comprising a matrix and at least one allergen are provided. Suitable matrices are gelatine, starch and mannitol. Methods for the dosage forms are also provided.

Abstract: The invention provides allergen containing pharmaceutical products and in particular fast-dispersing solid allergen dosage forms. In particular, fast-dispersing, non-compressed solid dosage forms suitable for oromucosal administration comprising a matrix and at least one allergen are provided. Suitable matrices are gelatine, starch and mannitol. Methods for the dosage forms are also provided.

Abstract: The present invention relates to novel recombinant protein variants that are useful as immunotherapeutic components. Also the present invention relates to DNA sequences encoding said protein variants as well as compositions comprising said protein variants.

Abstract: The invention discloses a method for standardizing allergen extract with respect to the contents of major as well as minor allergens. The method comprises determining relative amounts of allergens in a given extract, followed by an adjustment of the contents of major an minor allergens so as to meet predefined limitations. Also disclosed is an anti-allergy kit comprising means for profiling an allergic subject and an extract or series of extracts prepared according to the invention.

Abstract: The present invention relates to a method of preventive treatment of allergy to an allergen in a subject comprising a) administering an allergy vaccine containing the allergen as active substance to the subject via an oromucosal route, b) wherein the subject to be treated is unsensitised in the sense of exhibiting no lgE response specific to the allergen, c) wherein the subject to be treated is free of clinical symptoms of any allergy, and d) wherein the preventive treatment is aimed at preventing or reducing subsequent clinical symptoms of the allergy associated with the allergen.

Abstract: The present invention relates to a method of preventive treatment of allergy to an allergen in a subject comprising administering an allergy vaccine containing the allergen as active substance to a mucosal surface of the subject, a) wherein the subject to be treated is sensitised so as to exhibit an IgE response specific to the allergen, b) wherein the subject to be treated is free of clinical symptoms of the allergy associated with the allergen, and c) wherein the preventive treatment is aimed at preventing or reducing subsequent clinical symptoms of the allergy associated with the allergen.

Abstract: Use of a composition comprising an allergen and an adjuvant selected from the group consisting of oxygen-containing metal salts for the manufacture of a liquid formulation for preventing or treating allergy in a subject by oromucosal administration, and a method of preventing and treating allergy in a subject by oromucosal administration of the said liquid formulation.

Abstract: The present invention relates to a crystal structure of house dust mite allergen proDer p 1, the three-dimensional structure of proDer p 1 and the use of the three-dimensional structure to design a mutant of a protein belonging to the papain-like cysteine proteases.

Abstract: The invention relates to a method of preventing or treating an allergy to or an infection by a mucosal antigenic agent in a subject comprising a) subjecting the subject to a priming treatment by means of parenteral or adjuvant-facilitated mucosal administration to activate the systemic immune system, and b) subjecting the subject to Specific Allergy Vaccination (SAV) by means of non-gastrointestinal mucosal administration to elicit an antigenic agent specific Ig antibody response in the mucosa of the subject.

Abstract: Parenteral vaccine formulations and adjuvant compositions comprising certain salts as adjuvants are disclosed. Such parenteral vaccine formulations are used for generating an immune response in a subject following administration of the vaccine formulation or the adjuvant composition. Also disclosed is the use of these salts as adjuvants in parenteral vaccine formulations and adjuvant compositions, and to vaccine adjuvants comprising such salts.

Abstract: The present invention relates to processes for the preparation of a batch of an active pharmaceutical ingredient, e.g. an allergen product. The invention also relates to a container comprising cryogranules of a liquid composition of an allergen product, and to a cryogranule of an allergen product. The processes feature formation of cryogranules using a container having therein a cryogenic medium (e.g. liquid nitrogen) and storage of the cryogranules in the same container. The cryogranules obtained can be stored and handled without prior freeze-drying.

Abstract: The invention relates to a method of evaluating the therapeutic potential of a vaccination program comprising a vaccine for mucosal administration comprising one or more antigens and a vaccination protocol, the method comprising a) subjecting at least one test individual to the vaccination program, b) measuring the level of a biomarker antibody selected from the group consisting of IgA, IgG, IgE and IgX specific to the antigen in a biological sample from the test individual, and c) using the measurements obtained to evaluate the therapeutic potential of the vaccination program.

Abstract: The invention relates to a method of evaluating the immunological status of a subject comprising the steps of 1) determining the content of an antibody in a liquid sample from the subject using an immunoassay, wherein the reaction between the antibody of the sample and a ligand in the form of an antigen, an antibody or a hapten, the ligand being directed to the Fab region of the sample antibody, is carried out in the presence of other constituents of the sample to obtain a measurement 1, 2) determining the content of an antibody in the liquid sample using an immunoassay, wherein the reaction between the antibody of the sample and a ligand in the form of an antigen, an antibody or a hapten, the ligand being directed to the Fab region of the sample antibody, is carried out in the absence of other constituents of the sample to obtain a measurement 2, and 3) interrelating measurements 1 and 2 to express the interference and using the interference as a parameter for evaluating the immunological status of the subje

Abstract: The invention relates to An in vitro method of evaluating the immunological activity of a vaccine preparation in the form of a mixture of a molecular antigen and a carrier, wherein the mixture comprises a liquid phase and a solid phase, to which at least a part of the antigen is attached, the method comprising the steps of i) subjecting the vaccine to one or more measurements selected from the group consisting of: 1) the immunological activity of the mixture, 2) the immunological activity of antigen in the liquid phase, 3) the immunological activity of antigen in the solid phase, 4) the immunological activity of antigen in the liquid phase upon a treatment of the mixture to displace the antigen from the solid phase, and 5) the immunological activity of antigen in the solid phase upon a treatment of the mixture to displace the antigen from the solid phase, wherein the immunological activity measurement is selected from the group consisting of a) antibody binding capacity using an immunoassay employing an antig