Abstract: A process is provided for inhibiting symptoms of celiac disease, Clostridium difficile associated diseases such as Clostridium difficile colitis, pseudomembranous colitis and antibiotic associated diarrhea, food allergy or food intolerance in a subject that includes the oral administration to the subject suffering from food allergy or food intolerance an IgM. When administered in a, therapeutic quantity based on the subject characteristics and the type of IgM, symptoms of food allergy or food intolerance in that subject are inhibited. Even non-secretory forms of IgM are effective when administered orally.

Abstract: The present invention relates to neutralizing antibodies of the human pituitary adenylate cyclase activating polypeptide type I receptor (PAC1) and pharmaceutical compositions comprising such antibodies. Methods of treating or preventing headache conditions, such as migraine and cluster headache, using the neutralizing antibodies are also described.

Abstract: The invention relates to methods for preparing compositions comprising secretory-like immunoglobulin, in particular secretory-like IgA and/or secretory-like IgM, and compositions obtainable by the methods.

Abstract: A polyclonal antibody composition prepared from eggs of immunized hens is used to treat C. difficile infections. Respective groups of hens are immunized with Toxin A or Toxin B of Clostridium difficile or a Clostridium difficile spore preparation. The polyclonal antibodies are recovered from eggs pooled from the immunized hens and the resulting powder is administered in a therapeutically effective amount to individuals infected with or suspected of being infected with C. difficile.

Abstract: The present invention describes vaccines that comprise C. perfringens Type alpha toxoids, antigenic fragments thereof, inactivated antigenic fragments of C. perfringens Type alpha toxins, or any combination thereof. The present invention further describes methods of using with these vaccines to protect animals against clostridial diseases. The present invention also describes methods of making these vaccines.

Abstract: A process is provided for inhibiting symptoms of food allergy or food intolerance in a subject that includes the oral adminstration to the subject suffering from food allergy or food intolerance an IgM. When administered in a therapeutic quantity based on the subject characteristics and the type of IgM, symptoms of food allergy or food intolerance in that subject are inhibited. Even non-secretory forms of IgM are effective when administered orally.

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: Provided herein are reagents, compositions, and therapies with which to treat Clostridium difficile infection and related disease conditions and pathologies, such as Clostridium difficile-associated diarrhea, resulting from infection by Clostridium difficile bacteria and the enterotoxins produced by these bacteria. In particular, antibodies or antigen-binding fragments thereof that bind specifically to toxin A and/or toxin B of C difficile and neutralize the activities of these toxins; compositions comprising such antibodies; and methods of using the antibodies and the compositions are provided.

Abstract: The present invention describes vaccines that comprise C. perfringens Type alpha toxoids, antigenic fragments thereof, inactivated antigenic fragments of C. perfringens Type alpha toxins, or any combination thereof. The present invention further describes methods of using with these vaccines to protect animals against clostridial diseases. The present invention also describes methods of making these vaccines.

Abstract: The invention relates to compositions and methods to prevent enteric infection in a subject at risk of such infection. In particular, the invention relates to the prevention of recurrence of infection by Clostridium difficile.

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 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: Methods and compositions pertaining to botulinum neurotoxin (BoNT) light chain epitopes are provided. In particular, the methods and compositions relate to the use of real and mimetic BoNT light chain epitopes for generating an immune response in a subject, and for immunization against BoNT toxicity. Methods and compositions for detecting, isolating, and purifying BoNT epitopes and anti-BoNT antibodies are also provided.

Abstract: High affinity antibodies for binding epitopes of BoNT/B and hybridomas that produce such antibodies are described. The antibodies may be used in a kit for detecting BoNT/B in a sample.

Abstract: Methods for treating a pressure sore or for preventing development of a pressure sore by local administration of a Clostridial toxin, such as a botulinum neurotoxin, to a pressure sore or to a pressure point, or to the vicinity thereof.

Abstract: The present invention provides, among other aspects, methods for the manufacture of plasma-derived immunoglobulin G compositions highly enriched for anti-brain disease related protein antibodies (e.g., anti-A?, anti-RAGE, and anti-?-synuclein antibodies). Advantageously, the methods provided do not affect the manufacturing processes or capabilities for producing plasma-derived IgG therapeutics. Plasma-derived IgG compositions that are highly enriched for anti-brain disease related protein antibodies (e.g., anti-A?, anti-RAGE, and anti-?-synuclein antibodies), as also provided here. Methods for the treatment of brain diseases and disorders by administration of plasma-derived IgG compositions highly enriched for anti-brain disease related protein antibodies (e.g., anti-A?, anti-RAGE, and anti-?-synuclein antibodies), are also provided.

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: 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: Antibody product comprising n-specific antibodies characterized in that a) the n-specific antibodies in each case have an antibody content of at least 6/n % by weight of the total antibody component of the antibody product, and b) 2, 3 or more of the n-specific antibodies target lipopolysaccharide-expressing microorganisms, and c) the total amount of n-specific antibodies is 7% by weight of the total anti-body content of the antibody product.

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: 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: The present invention relates to recombinant Clostridium difficile antigens based on a fusion protein that consists of or comprises a first amino acid sequence and a second amino acid sequence, wherein: a) the first amino acid sequence is provided by an amino acid sequence that has at least 80% sequence identity with an amino acid sequence consisting of residues 500-1850 of a C. difficile Toxin A sequence or residues 1500-1851 of a C. difficile Toxin B sequence; and b) the second amino acid sequence is provided by an amino acid sequence that has at least 80% sequence identity with an amino acid sequence consisting of a long repeat unit located within amino acid residues 1851-2710 of a C. difficile Toxin A sequence or within amino acid residues 1852-2366 of a C. difficile Toxin B sequence; though with the proviso that the fusion protein is not a polypeptide comprising amino acid residues 543-2710 of a C.

Abstract: Provided is methods for producing mixtures of antibodies from a single host cell clone, wherein, a nucleic acid sequence encoding a light chain and nucleic acid sequences encoding different heavy chains are expressed in a recombinant host cell. The recombinantly produced antibodies in the mixtures according to the invention suitably comprise identical light chains paired to different heavy chains capable of pairing to the light chain, thereby forming functional antigen-binding domains. Mixtures of the recombinantly produced antibodies are also provided by the invention. Such mixtures can be used in a variety of fields.

Abstract: The present invention is directed to Clostridium difficile toxin-specific antibodies, compositions, and uses thereof. The anti-toxin antibodies may be specific for either TcdA or TcdB. The invention also includes methods of treating a Clostridium difficile infection, methods of capturing Clostridium difficile toxins, and methods of detecting Clostridium difficile toxins.

Abstract: The present invention provides fully human antibodies that bind to either toxin A or toxin B of Clostridium difficile, or to both toxin A and toxin B, compositions comprising the antibodies and methods of use. The antibodies of the invention are useful for neutralizing the toxins from C. difficile, thus providing a means of treating the disease and symptoms associated with a C. difficile infection, including the treatment of diarrhea, or pseudomembranous colitis caused by C. difficile. The antibodies may also prevent the severity and/or duration of the primary disease, or may prevent the number, duration, and/or the severity of recurrences, or relapses of the disease attributed to the presence of C. difficile. The antibodies of the invention may also be useful for diagnosis of an infection by C. difficile.

Abstract: Provided herein are reagents, compositions, and therapies with which to treat Clostridium difficile infection and related disease conditions and pathologies, such as Clostridium difficile-associated diarrhea, resulting from infection by Clostridium difficile bacteria and the enterotoxins produced by these bacteria. In particular, antibodies or antigen-binding fragments thereof that bind specifically to toxin A and/or toxin B of C difficile and neutralize the activities of these toxins; compositions comprising such antibodies; and methods of using the antibodies and the compositions are provided.

Abstract: A single polypeptide is provided which comprises first and second domains. The first domain enables the polypeptide to cleave one or more vesicle or plasma-membrane associated proteins essential to exocytosis, and the second domain enables the polypeptide to be translocated into a target cell or increases the solubility of the polypeptide, or both. The polypeptide thus combines useful properties of a clostridial toxin, such as a botulinum or tetanus toxin, without the toxicity associated with the natural molecule. The polypeptide can also contain a third domain that targets it to a specific cell, rendering the polypeptide useful in inhibition of exocytosis in target cells. Fusion proteins comprising the polypeptide, nucleic acids encoding the polypeptide and methods of making the polypeptide are also provided. Controlled activation of the polypeptide is possible and the polypeptide can be incorporated into vaccines and toxin assays.

Abstract: The present invention discloses methods for protecting newborn calves against neonatal diarrhea by vaccinating pregnant cows and/or pregnant heifers, while minimizing the number of separate occasions producers are required to assemble the cattle.

Abstract: A method is provided for improving the solubility of proteins, for example, bacterial toxins. In one embodiment, solubility is improved by introducing point mutations that replace cysteine residues capable of forming intermolecular disulfide bonds with other amino acid residues that do not form such bonds. By abrogating the ability of the cysteine residues to form inter-molecular disulfide bonds, aggregation of the protein is reduced, thereby improving the solubility of the protein. In another embodiment, solubility of the protein is improved by producing truncated forms of the protein that express the LHN domain and a fragment of the Hc domain. Proteins made according to the method of the invention are useful, for example, as immunodiagnostic agents and vaccine components.

Abstract: The present invention relates to methods and systems for administering antibody therapeutic agents. The methods include administering one or more (e.g., two or three) binding agents, wherein each of the binding agents has one or more monomers that have a binding region that is specific to a portion of a disease agent and one or more copies of a tag. The binding agents can be specific to one or more portions of the same or different disease agents. The tag is the same for each of the binding agents. The methods include administering an anti-tag antibody, wherein the anti-tag antibody has an anti-tag region that is specific to the tag, and can have an immunoglobulin (e.g., IgA, IgD, IgE, IgG, and IgM). Disease agents include bacteria, bacterial proteins, viruses, viral proteins, cancer cells, and proteins or toxins produced therefrom or from other sources such as snakes, insects, plants, etc.

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: The embodiment described herein are related nanoemulsions comprising botulinum toxins. In one embodiment, the nanoemulsions are prepared by high pressure microfluidization and comprise a particle size distribution exclusively between 10 and 300 nm. The nanoemulsions contemplated by the present invention are useful for the cosmetic and medical treatment of muscular contracture states. For example, botulinum toxin may relax facial muscles such that skin wrinkles become smoother and less noticeable. Further, the present invention contemplates a cosmetic formulation that may be self-administered, for example, in the privacy of one's home and without medical supervision.

Abstract: The disclosure provides specific and sensitive anti-toxin B antibodies and fragments thereof suitable for diagnosing Clostridium difficile infection. The antibodies and fragments recognize an epitope in the C-terminal 250-amino-acid region of toxin B of C. difficile, including epitopes defined by protein repeat sequences in this region of toxin B. This disclosure also provides the toxin B-specific epitope in the C-terminal 250-amino-acid region of toxin B of C. difficile for use in vaccine development as well as in the treatment of CDI disease and in treatment of the relapse of CDI disease. Also provided are toxin B polypeptides lacking the cytotoxic domain useful in treating or preventing CDI disease. PCR-based diagnostic assays targeting the 750-nucleotide region at the 3? end of tcdB are also provided.

Abstract: Antibodies that bind to botulinum neurotoxin(s) are disclosed herein, as well as related compositions and methods of use. The present disclosure provides antibodies that specifically bind a Botulinum neurotoxin (BoNT) and inhibit the activity of BoNT in cleavage of its substrate.

Abstract: This invention provides antibodies that specifically bind to and neutralize botulinum neurotoxin type A (BoNT/A) 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: Antibodies that specifically bind to toxins of C. difficile, antigen binding portions thereof, and methods of making and using the antibodies and antigen binding portions thereof are provided herein.

Abstract: Antibodies that specifically bind to toxins of C. difficile, antigen binding portions thereof, and methods of making and using the antibodies and antigen binding portions thereof are provided herein.

Abstract: The present invention provides compositions including siderophore receptor polypeptides and porins from gram negative microbes, and preferably, lipopolysaccarhide at a concentration of no greater than about 10.0 endotoxin units per milliliter. The present invention also provides methods of making and methods of using such compositions.

Abstract: A method and composition for treating enteric pathogen infections in animals suffering from such infections or displaying diseases or conditions consistent with such infections or for preventing or reducing the likelihood of enteric pathogen infections in animals at risk for developing such infections.

Abstract: Cell-based methods for rapid real time assay of a presence of Clostridium difficile toxin and/or cells are provided, using an assay having a toxin-enhancing antibody and a sensitive cell line carrying FcyR receptors, and kits for this assay. An ultrasensitive cell based immunocytotoxicity assay for detecting less then 1 pg/ml of C. difficile toxins in clinical samples. A TcdA-specific monoclonal antibody, AIH3, was found to significantly enhance the cytotoxicity of TcdA to macrophages and monocytes. The AIH3-dependent enhancement of glucosyltransferase activity, cytoskeleton disruption, and TNF-a production induced by TcdA was demonstrated also in RAW 264.7 cells. Methods for high level recombinant expression of C. difficile toxins in Bacillus cells, and vectors for expression, strains of Bacillus carrying the vectors are provided.

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: 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: A method is provided for improving the solubility of proteins, for example, bacterial toxins. In one embodiment, solubility is improved by introducing point mutations that replace cysteine residues capable of forming intermolecular disulfide bonds with other amino acid residues that do not form such bonds. By abrogating the ability of the cysteine residues to form inter-molecular disulfide bonds, aggregation of the protein is reduced, thereby improving the solubility of the protein. In another embodiment, solubility of the protein is improved by producing truncated forms of the protein that express the LHN domain and a fragment of the Hc domain. Proteins made according to the method of the invention are useful, for example, as immunodiagnostic agents and vaccine components.

Abstract: The invention relates to novel DNA and protein vaccines against Clostridium botulinum. The DNA vaccine includes a DNA molecule that includes a first segment encoding a fragment of a heavy chain region of a Clostridium botulinum neurotoxin, wherein the first segment is codon-enhanced to improve expression of the isolated DNA molecule in a mammalian host, and preferably a second segment that encodes a secretion signal peptide. The chimeric protein of the present invention includes the secretion signal peptide linked N-terminal of the fragment of a heavy chain region of a Clostridium botulinum neurotoxin. Use of these materials to raise antibodies, and to impart resistance against Clostridium botulinum to a mammal is also disclosed.

Abstract: Methods for treating skin disorders by local administration of a Clostridial toxin, such as a botulinum toxin, to a patient with a skin disorder.

Abstract: A single polypeptide is provided which comprises first and second domains. The first domain enables the polypeptide to cleave one or more vesicle or plasma-membrane associated proteins essential to exocytosis, and the second domain enables the polypeptide to be translocated into a target cell or increases the solubility of the polypeptide, or both. The polypeptide thus combines useful properties of a clostridial toxin, such as a botulinum or tetanus toxin, without the toxicity associated with the natural molecule. The polypeptide can also contain a third domain that targets it to a specific cell, rendering the polypeptide useful in inhibition of exocytosis in target cells. Fusion proteins comprising the polypeptide, nucleic acids encoding the polypeptide and methods of making the polypeptide are also provided. Controlled activation of the polypeptide is possible and the polypeptide can be incorporated into vaccines and toxin assays.

Abstract: A single polypeptide is provided which comprises first and second domains. The first domain enables the polypeptide to cleave one or more vesicle or plasma-membrane associated proteins essential to exocytosis, and the second domain enables the polypeptide to be translocated into a target cell or increases the solubility of the polypeptide, or both. The polypeptide thus combines useful properties of a clostridial toxin, such as a botulinum or tetanus toxin, without the toxicity associated with the natural molecule. The polypeptide can also contain a third domain that targets it to a specific cell, rendering the polypeptide useful in inhibition of exocytosis in target cells. Fusion proteins comprising the polypeptide, nucleic acids encoding the polypeptide and methods of making the polypeptide are also provided. Controlled activation of the polypeptide is possible and the polypeptide can be incorporated into vaccines and toxin assays.

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: This invention relates to antibodies with altered binding to FcRn, and particularly antibodies having enhanced binding to FcRn and/or enhanced serum half-lives. The invention also relates to methods of using the antibodies and compositions comprising them in the diagnosis, prognosis and therapy of diseases such as cancer, autoimmune diseases, inflammatory disorders, and infectious disease.