Polyclonal antibody composition for treating allergy

Abstract

A pharmaceutical composition for treating allergy is described. The composition comprises as an active ingredient a recombinant polyclonal antibody or a mixture of different monoclonal antibodies capable of reacting with or binding to an allergen together with one or more pharmaceutically acceptable excipients. The composition may be used topically as a solution, dispersion, powder, or in the form of microspheres. The polyclonal antibody is preferably a recombinant polyclonal antibody produced by phage display technology. The pairing of specific immunoglobulin variable region light chain and heavy chain maintained from the original polyclonal immune response or selected by panning using the allergen in question is preferably maintained by bulk transfer of the pairs into an expression vector.

1 . A pharmaceutical composition comprising as an active ingredient a recombinant polyclonal antibody or a mixture of individual monoclonal antibodies or an isolated or purified polyclonal antibody capable of reacting with or binding to an allergen together with one or more pharmaceutically acceptable excipients.  
     
     
         2 . The pharmaceutical composition of  claim 1 , wherein the active ingredient is a recombinant polyclonal antibody.  
     
     
         3 . The pharmaceutical composition of  claim 1 , wherein the active ingredient is a mixture of individual monoclonal antibodies.  
     
     
         4 . The pharmaceutical composition of  claim 1 , wherein the active ingredient is an isolated or purified polyclonal antibody.  
     
     
         5 . The pharmaceutical composition of  claim 1 , where the composition is free of the allergen to which the antibody is reactive or binds.  
     
     
         6 . The pharmaceutical composition of  claim 1 , wherein the composition comprises at least one pharmaceutically acceptable excipient capable of effecting topical application of said recombinant polyclonal antibody or said mixture of individual monoclonal antibodies or said isolated or purified polyclonal antibody.  
     
     
         7 . The pharmaceutical composition of  claim 5 , wherein said composition is intended for topical administration to the oropharynx, nasal cavity, respiratory tract, gastrointestinal tract, conjunctival mucosa, vagina, urogenital mucosa, or for dermal application.  
     
     
         8 . The pharmaceutical composition of  claim 7 , wherein the respiratory tract comprises the nasal, oral, pharyngeal, bronchial or alveolar mucosa.  
     
     
         9 . The pharmaceutical composition of  claim 1 , wherein said composition is provided as a solution, dispersion, powder, or in the form of microspheres.  
     
     
         10 . The pharmaceutical composition of  claim 2 , wherein the recombinant polyclonal antibody is generated by phage display technology.  
     
     
         11 . The pharmaceutical composition of  claim 10 , wherein the recombinant polyclonal antibody is generated under such conditions that the immunoglobulin heavy chain variable region and light chain variable region gene segments are linked together in a parental library in order to allow for the bulk transfer of variable region light chain and heavy chain gene pairs from one vector to another, while allowing stable pairing of specific immunoglobulin variable region light chain and heavy chain gene segments as they are present upon selection from the parental library of immunoglobulin variable region light chain and heavy chain gene segment pairs encoding antibody molecules capable of reacting with or binding to an allergen.  
     
     
         12 . The pharmaceutical composition of  claim 10 , wherein the recombinant polyclonal antibody is generated under such conditions that the immunoglobulin heavy chain variable region and light chain variable region gene segments are linked together in order to allow for the bulk transfer of specific variable region light chain and heavy chain gene pairs from one vector to another, while allowing stable pairing of specific immunoglobulin variable region light chain and heavy chain gene segments as they are present in the original polyclonal immune response of an animal or human individual.  
     
     
         13 . The pharmaceutical composition of  claim 1 , wherein the allergen is an allergen of a house dust mite, dander from a cat, a dog, or a horse, tree pollen, grass pollen, or fungi.  
     
     
         14 . The pharmaceutical composition of  claim 1 , wherein the recombinant polyclonal antibody or the mixture of monoclonal antibodies or the isolated or purified polyclonal antibody is provided in an amount in the range of 1 μg to 1 g per unit dosage form.  
     
     
         15 . The pharmaceutical composition of  claim 14 , wherein the recombinant polyclonal antibody or the mixture of monoclonal antibodies or the isolated or purified polyclonal antibody is provided in an amount in the range of 1 μg to 1000 μg per unit dosage form.  
     
     
         16 . A method of preventing or treating allergy, said method comprising administering to a patient in need thereof a pharmaceutical composition comprising as an active ingredient a recombinant polyclonal antibody or a mixture of individual monoclonal antibodies or an isolated or purified polyclonal antibody capable of reacting with or binding to an allergen to which the patient has shown or is predisposed to develop an allergic reactions together with one or more pharmaceutically acceptable excipients.  
     
     
         17 . A method of inducing tolerance to an allergen, said method comprising administering to a patient, who if untreated would be likely to show allergic reaction to the allergen, a composition comprising as an active ingredient a recombinant polyclonal antibody or a mixture of individual monoclonal antibodies or an isolated or purified polyclonal antibody capable of reacting with or binding to an allergen and inducing tolerance to the allergen in the patient.