Abstract: The present invention is directed to an antibody composition for oral administration comprising intact blood-derived polyclonal antibodies that bind to a human tumour necrosis factor ? (TNF?), and means for protecting the antibodies during gastrointestinal transit, as well as methods for manufacturing, kits, and therapeutic uses of the same.

Abstract: High resolution protein A chromatography employing a chaotropic agent and pH gradient or pH step elution buffer results in improved peak resolution between closely related molecular species. Bispecific antibodies containing a protein A-binding-ablating substitution CH3 domain paired with a protein A-binding CH3 domain are separated with high peak resolution from monospecific antibodies containing a protein A-binding-ablating substituted CH3 domain paired with the protein A-binding-ablating substituted CH3 domain and monospecific antibodies containing a protein A-binding CH3 domain paired with the protein A-binding CH3 domain. Useful chaotropic agents include magnesium chloride and calcium chloride.

Abstract: In place of a step of centrifugation during preparation of outer membrane vesicles (OMVs) from bacteria, the invention utilizes ultrafiltration. This allows much larger amounts of OMV-containing supernatant to be processed in a much shorter time. Thus the invention provides a process for preparing bacterial OMVs, comprising a step of ultrafiltration. The ultrafiltration step is performed on an aqueous suspension of OMVs after they have been prepared from bacteria and the OMVs remain in suspension after the filtration step. The invention is particularly useful for preparing OMVs from Neisseria meningitidis.

Abstract: The present invention describes novel hetero-dimeric immunoglobulins or fragments thereof which bind to CD3 and a disease associated antigen. These hetero-dimeric immunoglobulins have been engineered to promote hetero-dimer formation during expression and can be purified to a high degree using a Protein A differential purification technique.

Abstract: An isolated protein or peptide selected from the group consisting of Bordetella colonization factor A (BcfA) protein and antigenic fragments thereof is described, along with an isolated nucleic acid encoding the same, antibodies that bind to the same, methods of producing an immune response in a mammalian subject in need thereof by administering the proteins, peptides or antibodies, and pharmaceutical compositions comprising the same.

Abstract: Methods, compositions and kits are provided for treating a subject exposed to or at risk for exposure to a disease agent using a pharmaceutical composition including at least one recombinant heteromultimeric neutralizing binding protein including two or multiple binding regions, such that the binding regions are not identical, and each binding region specifically binds a non-overlapping portion of the disease agent, thereby treating the subject for exposure to the disease agent. In a related embodiment, the heteromultimeric neutralizing binding protein includes two or multiple binding regions that neutralize a plurality of disease agents. In certain embodiments, the disease agent includes a bacterium, a bacterial protein, a virus, a viral protein, a cancer cell, and a protein or molecule produced therefrom. In certain embodiments, the disease agent is a plurality of different disease agents.

Abstract: This disclosure provides antibodies that specifically bind to and typically neutralize botulinum neurotoxins (e.g., BoNT/A, BoNT/B, BoNT/E, etc.) and the epitopes bound by those antibodies. The antibodies and derivatives thereof and/or other antibodies that specifically bind to the neutralizing epitopes provided herein can be used to neutralize botulinum neurotoxin and are therefore also useful in the treatment of botulism.

Abstract: The present invention relates to chromatography matrices including ligands based on one or more domains of immunoglobulin-binding proteins such as, Staphylococcus aureus Protein A (SpA), as well as methods of using the same.

Abstract: The invention is directed to compositions and methods for generating or enhancing the immune system of a patient against infection by a pathogen, and in particular MTB. Compositions of the invention contain one or more non-naturally occurring antigens that generate an effective cellular or humoral immune response to MTB and/or antibodies that are specifically reactive to mycolic acid or to the surface of MTB. The greater activity of the immune system generated by a vaccine of the invention involve an conjugation of peptides to increase in the generation of memory T cells that provide for a greater and/or longer lived or extended response to an MTB infection. Preferably a response involves an increased generation of antibodies that enhance immunity against MTB infection and promote an enhanced phagocytic response.

Abstract: Provided are bivalent immunogenic composition against morphine-heroin addiction comprising a carrier protein (“CP”) and a morphinic product, wherein the CP and the morphinic product are connected by a spacer-linker arm having a total molecular size of 16-21 ?, and methods of using the same.

Abstract: Provided are oligonucleotides for isolating human antibody cDNAs from cells or cell lines, such as hybridomas. The invention also provides cDNAs that encode at least one provided CDR of a heavy chain or a light chain of a human monoclonal antibody that binds to B. anthracis protective antigen; and cDNAs that encode at least one provided CDR of a heavy chain or a light chain of a human monoclonal antibody that binds to B. anthracis lethal factor. The invention further provides expression vectors that contain one or more cDNAs isolated according to the methods of the invention, host cells expressing one or more inventive cDNAs, and transgenic plants and animals that express one or more inventive cDNAs. In certain embodiments of the invention the expression system is a plant-based expression system. The invention further provides antibody compositions comprising one or more antibodies produced by expressing a cDNA isolated according to the methods of the invention in a suitable expression system.

Abstract: A method for diagnosing Lyme disease status in a mammal is provided. The method entails, in a biological sample obtained or derived from a mammal, determining antibodies to Borrelia burgdorferi (B. burgdorferi) outer surface proteins (Osp) OspA, OspC, and OspF. Based upon determining the OspA, OspC, and OspF antibodies, the mammal can be diagnosed as vaccinated, not vaccinated, infected or not infected with B. burgdorferi. Mammals that have early, intermediate or chronic B. burgdorferi infection can also be identified. The method is particularly suited for use with horses and dogs. Isolated or recombinant B. burgdorferi antigens and compositions that contain them are also provided.

Abstract: The invention provides active and passive immunization methods for preventing and treating Clostridium difficile infection, which involve percutaneous administration of C. difficile toxin-neutralizing polyclonal immune globulin, C. difficile toxoids, or combinations thereof. Also provided by the invention are C. difficile toxoids, C. difficile toxin-neutralizing polyclonal immune globulin, and methods of identifying subjects that produce C. difficile toxin-neutralizing polyclonal immune globulin.

Abstract: The current invention provides high-affinity antibodies to the Pseudomonas aeruginosa PcrV protein that have reduced immunogenicity when administered to treat Pseudomonas aeruginosa infections.

Abstract: A detection method and a detection kit for rapidly and specifically diagnosing Mycoplasma pneumoniae and/or Mycoplasma genitalium infections are provided. The DnaK of Mycoplasma pneumoniae or Mycoplasma genitalium is used as an indicator.

Abstract: This disclosure relates to combination therapies comprising anti-Pseudomonas Psl and PcrV binding molecules and related compositions, for use in prevention and treatment of Pseudomonas infection.

Abstract: The present invention provides an antibody composition comprising ovine antibodies, for use in the prevention or treatment of C. difficile infection wherein the antibodies bind to a C. difficile toxin.

Abstract: The present invention is drawn to the nucleic and amino acid sequences encoding vaginolysin (VLY) toxin from Gardnerella vaginalis, and biologically active fragments and variants thereof. The invention is also directed to anti-VLY antibodies and to their use therapeutically and in a new ELISA assay of VLY toxin. Other embodiments of the invention are directed to VLY toxoids and to vaccines that use the new VLY toxoids as immunogens.

Abstract: Anti-toxin compositions are described that include avian antibodies against bacterial toxins. Administration of the anti-toxin compositions binds and neutralizes the bacterial toxin in the animals. Methods of making the anti-toxin compositions against the bacterial toxins are also described. The anti-toxin compositions can be effective against pathogenic bacteria and also to decrease the amount of bacterial toxins in the individual, especially in the GI tract. The anti-toxin compositions can also act as anti-inflammatory agents.

Abstract: The present invention relates to a diagnostic method for the detection of acute leptospirosis. The method of the invention allows for a quick, specific and sensitive detection of the disease caused by pathogenic Leptospira. The described method is based on the immunological detection of the protein LipL21, a membrane protein expressed specifically by pathogenic strains of Leptospira. Furthermore, the present invention relates to the development of a diagnostic device that allows positive diagnosis to be conducted in the early and critical stage of the infection. The preferred diagnostic device of the invention is a lateral flow test, which as a hand-held assay, is easy to use and facilitates diagnosis of leptospirosis in the first 5 days of infection. Further disclosed is the antibody raised against the LipL21 protein as well as its respective uses in the diagnostic methods and devices.

Abstract: The present invention provides an antibody composition comprising ovine antibodies, for use in the prevention or treatment of C. difficile infection wherein the antibodies bind to a C. difficile toxin, and wherein said prevention or treatment is by oral delivery of the antibody composition. Also provided is a pharmaceutical composition of ovine antibodies for oral delivery, which further comprises one or more means for protecting the antibodies from trypsin and/or chymotrypsin and/or stomach acid.

Abstract: A nanoantibody specifically binding surface antigen of Chlamydia trachomatis and having SEQ ID NO:2 amino acid sequence is disclosed. A nanoantibody specifically binding surface antigen of Chlamydia trachomatis and having SEQ ID NO:4 amino acid sequence is disclosed. A nanoantibody with SEQ ID NO:2 amino acid sequence inhibits development of Chlamydia infection caused by C. trachomatis. A nanoantibody with SEQ ID NO:4 amino acid sequence inhibits development of Chlamydia infection caused by C. trachomatis. A method of in vitro inhibiting a Chlamydia infection caused by C. trachomatis has the steps of pretreating elementary bodies of C. trachomatis by a therapeutically efficient amount of a nanoantibody specifically binding to a surface antigen of Chlamydia trachomatis, the nanoantibody comprising an amino acid sequence SEQ ID NO: 4 or SEQ ID NO:4, and then adding the elementary bodies of C. trachomatis to target cells being infected.

Abstract: There is disclosed compositions and methods relating to or derived from anti-AIP2 antibodies. More specifically, there is disclosed fully human antibodies that bind AIP2, AIP2-binding fragments and derivatives of such antibodies, and AIP2-binding polypeptides comprising such fragments. Further still, there is disclosed nucleic acids encoding such antibodies, antibody fragments and derivatives and polypeptides, cells comprising such polynucleotides, methods of making such antibodies, antibody fragments and derivatives and polypeptides, and methods of using such antibodies, antibody fragments and derivatives and polypeptides, including methods of treating or diagnosing subjects having AIP2 related disorders or conditions. There is also disclosed a method to treat S. aureus infections by administering an anti-AIP2 antibody described herein.

Abstract: The present invention provides methods and devices for detecting the presence of biomolecules in a biological sample, such as PVL, PBP2a and SPA.

Abstract: Compositions and methods for conferring pesticidal activity to bacteria, plants, plant cells, tissues and seeds are provided. Compositions comprising a coding sequence for pesticidal polypeptides are provided. The coding sequences can be used in DNA constructs or expression cassettes for transformation and expression in plants and bacteria. Compositions also comprise transformed bacteria, plants, plant cells, tissues, and seeds. In particular, isolated pesticidal nucleic acid molecules are provided. Additionally, amino acid sequences corresponding to the polynucleotides are encompassed. In particular, the present invention provides for nucleic acid molecules comprising nucleotide sequences encoding the amino acid sequence shown in SEQ ID NO:7, 8, 9, 10, 11, or 12, the nucleotide sequence set forth in SEQ ID NO:4, 5, or 6, as well as variants and fragments thereof.

Abstract: In some aspects, provided are methods relating to the use of bacterial N-methyl-2 superfamily proteins as a biomarker for the presence of bacteria in a sample. The invention also relates to novel methods of diagnosis of the presence of bacteria in a liquid or solid sample, detection of bacterial infections in humans or animals, and use of antibodies or other specific binding molecules capable of binding to N-methyl-2 superfamily proteins.

Abstract: This invention relates to stable formulations of multiple antibodies comprising a plurality of anti-botulism antibodies and an effective amount of a succinate buffer, an effective amount of arginine, wherein the antibodies are present in substantially equal concentrations and the pH of the formulation is between about 5 and about 6.5.

Abstract: The invention concerns a peptide or arrangement of peptides forming a Staphylococcus aureus epitope binding site comprising a first amino acid sequence and a second amino acid sequence, wherein the first amino acid sequence is at least 88% identical to sequence SEQ ID NO:1 and wherein the second amino acid sequence is at least 88% identical to sequence SEQ ID NO: 2.

Abstract: For many diseases due to microbes or the like, proliferation of microbes themselves is a cause of a symptom. However, there were cases where a substance released by the microbes is a cause of a symptom. In such cases, when attempting to treat a disease with an antibody, it was necessary to obtain an antibody against an antigen that is a substance causing the disease. However, it was difficult to find the underlying substance causing the disease among substances released by the microbes. An antibody (polyclonal) binding to not only an antigen but also to a substance, which is secreted by the antigen and accelerates the deterioration of a symptom, is obtained by immunizing birds with a lysis solution produced from lysing microbial cells as an antigen. Further, an antibody obtained with a surface protein of a virus as an antigen is expected to inhibit an infection by a virus.

Abstract: The present invention provides improved binding compounds capable of specifically binding Gram-positive bacteria. Binding compounds are provided that are fully human, enabling therapeutic applications in human individuals.

Abstract: The present invention relates to an isolated antigen from Streptomyces coelicolor that is useful for developing, inter alia, vaccines against pathogenic bacteria of humans and animals. The present invention also relates to vaccines and antibodies developed using the isolated antigen. The present invention also relates to methods of using the antigen, vaccines, and antibodies of the present invention to detect, treat, and prevent infection and diseases associated with pathogenic bacteria.

Abstract: The present invention relates to methods and compositions for the treatment and prevention of diarrhea and diarrheal related diseases and disorders in both animals and humans. In some embodiments, the invention relates to the treatment of said diarrhea and diarrheal related diseases and disorders with a vaccine. In still further embodiments, the invention relates to the treatment of constipation using the disclosed methods and compositions.

Abstract: There is disclosed compositions and methods relating to or derived from anti-AIP2 antibodies. More specifically, there is disclosed fully human antibodies that bind AIP2, AIP2-binding fragments and derivatives of such antibodies, and AIP2-binding polypeptides comprising such fragments. Further still, there is disclosed nucleic acids encoding such antibodies, antibody fragments and derivatives and polypeptides, cells comprising such polynucleotides, methods of making such antibodies, antibody fragments and derivatives and polypeptides, and methods of using such antibodies, antibody fragments and derivatives and polypeptides, including methods of treating or diagnosing subjects having AIP2 related disorders or conditions. There is also disclosed a method to treat S. aureus infections by administering an anti-AIP2 antibody described herein.

Abstract: The present invention provides isolated polypeptides isolatable from a Staphylococcus spp. Also provided by the present invention are compositions that include one or more of the polypeptides, and methods for making and methods for using the polypeptides.

Abstract: The present invention provides an antibody composition comprising ovine antibodies, for use in the prevention or treatment of C. difficile infection wherein the antibodies bind to a C. difficile toxin.

Abstract: The present invention relates to the use of a composition selected from the group consisting of antibodies, antibody fragments, insulin-like growth factor antagonists, Toll-like receptor antagonists and mixtures thereof for the treatment or the prophylaxis of certain diseases.

Abstract: This invention provides antibodies that specifically bind to and typically neutralize botulinum neurotoxins (e.g., BoNT/A, BoNT/B, BoNT/E, etc.) and the epitopes bound by those antibodies. The antibodies and derivatives thereof and/or other antibodies that specifically bind to the neutralizing epitopes provided herein can be used to neutralize botulinum neurotoxin and are therefore also useful in the treatment of botulism.

Abstract: An object of the present invention is to provide a technique to create novel engineered protein ligands that, when immobilized through a lysine residue (its side chain ?-amino group) which allows for efficient immobilization to a carrier, show the optimum binding capacity and binding efficiency to a target molecule. The present invention provides an engineered protein having a sequence obtained by replacing all the lysine residues in Protein A, which is the most typical protein ligand, with other amino acids, and adding lysine at a terminal; and an affinity separation matrix in which such an engineered protein is immobilized on a water-insoluble carrier by reductive amination or the like. This affinity separation matrix is characterized by its high binding capacity to a target molecule even when the immobilized amount of the ligand is small.

Abstract: The invention provides a washing method for affinity chromatography in which a wash solution comprising arginine, or an arginine derivative, at pH greater than 8.0, is effective in removing impurities without the presence of a nonbuffering salt, while simultaneously increasing product concentration in the eluate and maintaining a high percent yield of recovered product.

Abstract: It has been demonstrated that the level of HBP increases in individuals that have bacterial meningitis. Accordingly, the level of HBP in an individual can be used to determine whether or not an individual has bacterial meningitis.

Abstract: Herein provided are compositions, methods of manufacture and methods of use pertaining to anti-alpha toxin antibodies and fragments.

Abstract: The present invention concerns methods and compositions for treating or preventing a bacterial infection, particularly infection by a Staphylococcus bacterium. The invention provides methods and compositions for providing a passive immune response against the bacteria. In certain embodiments, the methods and compositions involve an antibody, such as a recombinant antibody, that binds IsdA and/or IsdB polypeptides.

Abstract: The present invention relates to the preparation of a set of depleted polyclonal antibodies, each depleted polyclonal antibody being raised against one specific staphylococcal enterotoxin, and its use for multiplex detection.

Abstract: Therapeutic, diagnostic and environmental monitoring methods employing proteins encoded by the rbmBCDEF gene cluster and by bap1.

Abstract: Human antibodies that bind to one or more strains Staphylococcus aureus strains, including methicillin resistant strains, are disclosed. Also disclosed are human recombinant polyclonal antibody compositions, and therapeutic methods for using the antibodies.

Abstract: Anti-toxin compositions are described that include avian antibodies against bacterial toxins. Administration of the anti-toxin compositions binds and neutralizes the bacterial toxin in the animals. Methods of making the anti-toxin compositions against the bacterial toxins are also described. The anti-toxin compositions can be effective against pathogenic bacteria and also to decrease the amount of bacterial toxins in the individual, especially in the GI tract. The anti-toxin compositions can also act as anti-inflammatory agents.

Abstract: Compositions, methods and kits are provided for identifying at least one virulence factor of a Gram-negative bacterial strain, and for preparing attenuated bacterial strain vaccines or a modulator that selectively binds to or inhibits expression of the virulence factor. The Gram-negative bacterial strain is a short facultatively aerobic or micro-aerobic rod or an enteric strain including at least one pathogen selected from the group of: Salmonella, Escherichia, Yersinia, Klebsiella, Shigella, Enterobacter, Serratia, Pseudomonas, and Citrobacter. Novel genes encoding virulence factors are identified, so that non-virulent mutant strains are available for vaccine development.

Abstract: The present invention relates to a method of separating one or more immunoglobulin containing proteins from a liquid. The method includes first contacting the liquid with a separation matrix comprising ligands immobilised to a support; allowing the immunoglobulin containing proteins to adsorb to the matrix by interaction with the ligands; followed by an optional step of washing the matrix containing the immunoglobulin containing proteins adsorbed thereon; and recovering said immunoglobulin containing proteins by contacting the matrix with an eluent which releases the proteins.

Abstract: This invention provides antibodies that specifically bind to and typically neutralize botulinum neurotoxins (e.g., BoNT/A, BoNT/B, BoNT/E, etc.) and the epitopes bound by those antibodies. The antibodies and derivatives thereof and/or other antibodies that specifically bind to the neutralizing epitopes provided herein can be used to neutralize botulinum neurotoxin and are therefore also useful in the treatment of botulism.

Abstract: A novel and rapid diagnostic method for anthrax infection is provided. Three B. anthracis gene products are described, as well as antibodies against the same, which may be used for the detection and monitoring of anthrax infection. Kits for the diagnosis of anthrax are also provided.