Abstract: The invention relates to a pharmaceutical product comprising an allergen extract or an allergoid thereof for the treatment and/or prevention of allergy and allergic asthma caused by house dust mites, which extract comprises at least one extract of mite bodies selected from the following groups a)-b): a) An extract of Der p mite bodies, and b) An extract of Der f mite bodies, and at least one extract of mite cultures selected from the following groups c)-g): c) An extract of Der p faecal particles, d) An extract of Der f faecal particles, e) An extract of Der f whole mite culture, f) An extract of an Der p whole mite culture, and g) a combination of extracts c) to f).

Abstract: This invention relates to the use of a pharmaceutical product comprising allergen and optionally an adjuvant for fast up-dosing in connection with allergy vaccination wherein a reduced number of injections are used. The invention also relates to the pharmaceutical product as such.

Abstract: The present invention provides a non-compressed fast-dispersing solid dosage form suitable for oromucosal administration of a pharmaceutically active substance comprising (a) a first matrix forming agent in the form of maltodextrin having a dextrose equivalent (DE) of between 1 and 20, (b) a second matrix forming agent in the form of sorbitol, and (c) the active substance.

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 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 relates to mucosal allergen-specific immunotherapy with a seasonal allergen, wherein the therapy is initiated after start of the pollen season of the seasonal allergen. Preferably, the seasonal allergen is provided in solid dosage form and is administered daily. Furthermore, advantageously, the same dose may be used throughout the treatment period since up-dosing is not required.

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 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: Novel recombinant allergens with multiple mutations and reduced IgE binding affinity are disclosed. The allergens are mutants of naturally occurring allergens. The overall ?-carbon backbone tertiary structure is essentially preserved. Also disclosed is a method for preparing such recombinant allergens as well as uses thereof.

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 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; and ii) using the measurement results to evaluate the immunological activity of the vaccine.

Abstract: The present invention relates to an allergy vaccine composition for mucosal administration comprising a cysteine protease allergen in a reduced active state or in an oxidised inactive state, The inventions further relates to an adjuvant system for use in a vaccine for mucosal administration comprising a cysteine protease.

Abstract: The present invention provides a container for storing a blister package and for managing medication with a pharmaceutical composition comprised in the blister package. The container comprises a housing which forms a compartment for the blister package, means for indicating towards a user an appropriate time of accessing the blister package, and means for detecting a users access to a blister package in the compartment. The blister package is moved into and out of the compartment by means of an ejection structure to which the blister package may be fixed. The ejection structure facilitates an enhanced handling of the blister package during insertion and removal of the blister package and facilitates a more accurate indication of a user's access to the blister package.

Abstract: The present invention relates to a process for producing mature recombinant Mite Group I allergen comprising the steps of a) providing an allergen expression system in the form of a host cell selected from the group of yeasts containing a vector comprising cDNA encoding pro-allergen, b) cultivating the allergen expression system at a cultivation pH of between 5.5 and 7.5 for a cultivation period to express pro-allergen to obtain a cultivation mixture containing pro-allergen, c) adjusting the pH of the cultivation mixture to a maturation pH of between 3.5 and 5.0, d) maintaining the cultivation mixture at the maturation pH for a maturation period to convert the pro-allergen into mature allergen to obtain a product mixture, and e) subjecting the product mixture to a purification method to isolate mature allergen from the product mixture.

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: Methods of detecting and/or quantifying an IgE antibody present in a liquid sample. The IgE antibody is specific to a ligand in the form of an antigen, an antibody, or a hapten. These methods can be used for monitoring and evaluating the immunological status of a subject.

Abstract: The present invention relates to the use of a Der f 2 allergen composition for the manufacture of a vaccine for preventing or treating allergy to Der p 2, as well as to the use of a Der p 2 allergen composition for the manufacture of a vaccine for treating allergy to Der f 2.

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: A method for culturing and producing mites, such as house dust mites, comprising culturing the mites in a suitable solid growth medium, under suitable conditions and for a suitable period of time in a suitable production room, characterized in that the mites are cultured in medium comprised within a closed bag.

Abstract: The invention relates to a method of measuring the immunological activity of a vaccine preparation in the form of a mixture of one or more allergenic enzyme(s) and an oxygen-containing metal salt adjuvant, wherein the mixture comprises a liquid phase and a solid phase, and wherein at least a part of the allergenic enzyme(s) is adsorbed to the solid phase, the method comprising the steps of measuring the enzymatic activity of the mixture in an enzyme activity assay, and using the measurement obtained as an indication of the immunological activity of the vaccine preparation, or using the measurement obtained for quantifying the amount of allergenic enzyme.