Abstract: The invention is directed to vaccines comprising capsular polysaccharides conjugated to one or more components of virus like particles (VLP), and methods for the administration of and methods for the manufacture of vaccines of the invention. Preferably vaccines of the invention generate a therapeutically effective response in an individual in need thereof to multiple strains and/or serotypes of the same or of different infectious agents. Preferably such vaccines generate a therapeutically effective immune response to all pathogenic strains and/or serotypes of the same infectious agent. In particular, the invention is directed to methods and compositions for the cost efficient administration of a vaccine to a patient in need thereof exposing the patient's immune system to only the immunogenic components that are likely to be beneficial for the generation of a protective immunological response, both efficacy and safety are increased and cost effectively.

Abstract: Disclosed is a double chamber container. The first chamber comprises a stopper coupled to a first end and a cover coupled to a second end. The second chamber comprises a plunger coupled to one end and an open second end. The first chamber is coupled to the second chamber such that the first end of the first chamber is coupled to the second end of the second chamber.

Abstract: The invention is directed to compositions and methods for the stabilization of viral and bacterial vaccines. Vaccines of the invention are contained in VLPs with stabilizing agents such as, for example, sugar alcohols (e.g., sorbitol) and degraded gelatins. Preferably the gelatin has an average molecular weight of 10,000 kilodaltons or less. These vaccines have a substantially improved thermostability as well as long term stability. The invention is also directed to the manufacture of a vaccine or the invention and methods for the administration of a vaccine of the invention to patients.

Abstract: The invention is directed to compositions and methods for the stabilization of viral and bacterial vaccines. Vaccines of the invention are contained in VLPs with stabilizing agents such as, for example, sugar alcohols (e.g., sorbitol) and degraded gelatins. Preferably the gelatin has an average molecular weight of 10,000 kilodaltons or less. These vaccines have a substantially improved thermostability as well as long term stability. The invention is also directed to the manufacture of a vaccine or the invention and methods for the administration of a vaccine of the invention to patients.

Abstract: This invention is directed to composition, vaccines, tools and methods in the treatment and prevention of Bordetella pertussis. In particular, the invention is directed to a three-pronged approach that involves removal of the nonessential vaccine components, use of a nondenatured, genetically detoxified mutant, and adding virulence factors.

Abstract: The invention is directed to vaccines comprising capsular polysaccharides conjugated to one or more components of virus like particles (VLP), and methods for the administration of and methods for the manufacture of vaccines of the invention. Preferably vaccines of the invention generate a therapeutically effective response in an individual in need thereof to multiple strains and/or serotypes of the same or of different infectious agents. Preferably such vaccines generate a therapeutically effective immune response to all pathogenic strains and/or serotypes of the same infectious agent. In particular, the invention is directed to methods and compositions for the cost efficient administration of a vaccine to a patient in need thereof exposing the patient's immune system to only the immunogenic components that are likely to be beneficial for the generation of a protective immunological response, both efficacy and safety are increased and cost effectively.

Abstract: The disclosure describes compositions containing PEGylated compounds using linkers, bivalent polysaccharide covalent PEG compounds, and methods of bivalent polysaccharide-PEG compounds in the development of multivalent vaccines. PEGylated conjugation of capsular polysaccharides to carrier proteins is carried out using homo-bifunctional and/or hetero-bifunctional linkers of specific lengths. Incorporation of bifunctional PEG linkers induces higher titers of functional antibodies with high avidity, eliciting higher immunologic memory, and reduced carrier protein effect. This provides immunochemically cross-reactive capsular polysaccharides wherein one or more cross-reactive capsular polysaccharides are covalently PEG compounded sequentially or concurrently to carrier protein using bifunctional linkers bearing the same or different functional groups.

Abstract: An improved, cost effective and shortened process of purification of the capsular polysaccharide of S. pneumoniae, Group B Streptococcus, H. influenzae, S. typhoid and N. meningitidis is disclosed. The process includes a cocktail of enzyme treatment, tangential flow filtration, and multimodal chromatography purification. For Gram-negative bacteria, endotoxin removal process involves endotrap HD resin. This shortened process achieved the purity required by WHO/EP/BP for the use in human vaccine preparation, with simple steps and higher yield as compared to conventional processes. The steps of the process avoid use of organic solvents such as, for example, alcohol, phenol, and ultracentrifugation that are otherwise expensive and time consuming to perform, and/or health hazards for commercial use. This process disclosed is also simple, efficient, non-toxic, easy to scale-up, and environmentally friendly.

Abstract: The disclosure describes compositions containing conjugates using novel linkers, bivalent polysaccharide conjugates, and methods of bivalent polysaccharide conjugation in the development of multivalent conjugate vaccines. Conjugation of capsular polysaccharides to carrier proteins is carried out using homo-bifunctional and/or hetero-bifunctional linkers of specific lengths. Incorporation of the linkers and their use in bifunctional linkers induces higher titers of functional antibodies with high avidity, eliciting higher immunologic memory, and reduced carrier protein effect. This provides immunochemically cross-reactive capsular polysaccharides wherein one or more cross-reactive capsular polysaccharides are conjugated sequentially or concurrently to carrier protein using bifunctional linkers bearing the same or different functional groups.

Abstract: The invention is directed to tools, compositions, and methods for the cultivation of microorganisms in culture media that is devoid of animal-derived materials such as blood, and, in particular, to compositions of meat-free media.

Abstract: An integrated platform system controlled with hardware and software for just-in-time, local manufacturing is disclosed. System hardware may include a fermentation system, a cross-flow system, a disposable formulation system, a robotic fill-finish system, and a quality control test and release system.

Abstract: The disclosure describes compositions containing PEGylated compounds using linkers, bivalent polysaccharide covalent PEG compounds, and methods of bivalent polysaccharide-PEG compounds in the development of multivalent vaccines. PEGylated conjugation of capsular polysaccharides to carrier proteins is carried out using homo-bifunctional and/or hetero-bifunctional linkers of specific lengths. Incorporation of bifunctional PEG linkers induces higher titers of functional antibodies with high avidity, eliciting higher immunologic memory, and reduced carrier protein effect. This provides immunochemically cross-reactive capsular polysaccharides wherein one or more cross-reactive capsular polysaccharides are covalently PEG compounded sequentially or concurrently to carrier protein using bifunctional linkers bearing the same or different functional groups.

Abstract: An improved, cost effective and shortened process of purification of the capsular polysaccharide of S. pneumoniae, Group B Streptococcus, H. influenzae, S. typhoid and N. meningitidis is disclosed. The process includes a cocktail of enzyme treatment, tangential flow filtration, and multimodal chromatography purification. For Gram-negative bacteria, endotoxin removal process involves endotrap HD resin. This shortened process achieved the purity required by WHO/EP/BP for the use in human vaccine preparation, with simple steps and higher yield as compared to conventional processes. The steps of the process avoid use of organic solvents such as, for example, alcohol, phenol, and ultracentrifugation that are otherwise expensive and time consuming to perform, and/or health hazards for commercial use. This process disclosed is also simple, efficient, non-toxic, easy to scale-up, and environmentally friendly.

Abstract: The invention is directed to an oral vaccine composed of a micronized freeze-dried rotavirus particle suspension with buffering excipients in a non-aqueous liquid. This IVT-06 formulation has imparted heat stability by protecting the virus at temperatures of 30° C. and 40° C. for at least twelve months. Extrapolations from the 12-month stability data indicate a shelf life of more than two years at 30° C., and six months at 50° C. In addition, for ease of administration, the formulated dose has a volume of 0.5 mL.

Abstract: This invention is directed to immunogenic composition, conjugates, virus-lie particles (VLP) compositions, vaccines and methods directed to the treatment and/or prevent of infection by Human Papillomavirus.

Abstract: An improved, cost effective and shortened process of purification of the capsular polysaccharide of S. Pneumoniae, Group B Streptococcus, H. Influenzae, S. Typhoid and N. meningitidis is disclosed. The process includes a cocktail of enzyme treatment, tangential flow filtration, and multimodal chromatography purification. For Gram-negative bacteria, endotoxin removal process involves endotrap HD resin. This shortened process achieved the purity required by WHO/EP/BP for the use in human vaccine preparation, with simple steps and higher yield as compared to conventional processes. The steps of the process avoid use of organic solvents such as, for example, alcohol, phenol, and ultracentrifugation that are otherwise expensive and time consuming to perform, and/or health hazards for commercial use. This process disclosed is also simple, efficient, non-toxic, easy to scale-up, and environmentally friendly.

Abstract: The invention is directed to an oral vaccine composed of a micronized freeze-dried rotavirus particle emulsion with buffering excipients in a non-aqueous liquid. This IVT-06 formulation has imparted heat stability by protecting the virus at temperatures of 30° C. and 40° C. for at least twelve months. Extrapolations from the 12-month stability data indicate a shelf life of more than two years at 30° C., and six months at 50° C. In addition, for ease of administration, the formulated dose has a volume of 0.5 mL.

Abstract: The invention is directed to vaccines comprising capsular polysaccharides conjugated to one or more components of virus like particles (VLP), and methods for the administration of and methods for the manufacture of vaccines of the invention. Preferably vaccines of the invention generate a therapeutically effective response in an individual in need thereof to multiple strains and/or serotypes of the same or of different infectious agents. Preferably such vaccines generate a therapeutically effective immune response to all pathogenic strains and/or serotypes of the same infectious agent. In particular, the invention is directed to methods and compositions for the cost efficient administration of a vaccine to a patient in need thereof exposing the patient's immune system to only the immunogenic components that are likely to be beneficial for the generation of a protective immunological response, both efficacy and safety are increased and cost effectively.

Abstract: An improved, cost effective and shortened process of purification of the capsular polysaccharide of S. Pneumoniae, Group B Streptococcus, H. Influenzae, S. Typhoid and N. meningitidis is disclosed. The process includes a cocktail of enzyme treatment, tangential flow filtration, and multimodal chromatography purification. For Gram-negative bacteria, endotoxin removal process involves endotrap HD resin. This shortened process achieved the purity required by WHO/EP/BP for the use in human vaccine preparation, with simple steps and higher yield as compared to conventional processes. The steps of the process avoid use of organic solvents such as, for example, alcohol, phenol, and ultracentrifugation that are otherwise expensive and time consuming to perform, and/or health hazards for commercial use. This process disclosed is also simple, efficient, non-toxic, easy to scale-up, and environmentally friendly.

Abstract: This invention is directed to composition, vaccines, tools and methods in the treatment and prevention of Bordetella pertussis. In particular, the invention is directed to a three-pronged approach that involves removal of the nonessential vaccine components, use of a nondenatured, genetically detoxified mutant, and adding virulence factors.