Abstract: A stable liquid pharmaceutical preparation of an anti-influenza virus antibody and, more specifically, a stable liquid pharmaceutical preparation that comprises: (A) an anti-influenza virus antibody or a mixture of two or more different types of anti-influenza virus antibodies; (B) a surfactant; (C) a sugar or a sugar derivative; and (D) an amino acid. The stable liquid pharmaceutical preparation for an anti-influenza virus antibody disclosed herein has excellent storage stability at low temperature (5° C.), room temperature (25° C.), and high temperature (40° C.) and excellent long-term (12 months) storage stability, and may be administered intravenously, intramuscularly, transdermally, subcutaneously, intraperitoneally, topically, or in combinations thereof.

Abstract: In various aspects and embodiments the invention provides compositions and methods for facilitating cell penetration of a cargo molecule. In another aspect, the invention provides a method of preventing viral infection in a subject in need thereof, the method comprising providing to the subject a therapeutically effective amount of a polypeptide comprising a cell-penetrating peptide and a retromer binding site.

Abstract: The present application provides a bispecific antibody against rabies virus, and an application thereof. The bispecific antibody comprises two antigen-binding fragments binding to different epitopes of G protein of rabies virus, and has rabies virus neutralization activity.

Abstract: The present disclosure provides synthetic modular polypeptide libraries and nucleic acids encoding such synthetic modular polypeptide libraries. Also provided are methods of making synthetic modular polypeptide libraries and nucleic acids encoding synthetic modular polypeptide libraries. Methods of screening a synthetic modular polypeptide library to identify a selected phenotype associated with a member of a synthetic modular polypeptide library are also provided where such methods find use in both in vitro and in vivo assays.

Abstract: The present invention relates to an immunogenic polypeptide comprising a multitude of papillomavirus (PV) L2 N-terminal peptides corresponding to amino acids 20 to 50 of the L2 polypeptide of HPV16, wherein said HPV L2 N-terminal peptides are L2 N-terminal peptides from at least four different cutaneous HPV genotypes; and to the aforesaid immunogenic polypeptide for use in medicine and for use in vaccination of a subject against cutaneous HPV infection and/or mucosal HPV infection. The present invention further relates to a polynucleotide encoding the aforesaid immunogenic polypeptide and to vectors, host cells, methods for producing an antibody, as well as antibodies related thereto.

Abstract: The present invention provides recombinant herpesvirus of turkeys (HVT) vectors that contain and express antigens of avian pathogens, compositions comprising the recombinant HVT vectors and polyvalent vaccines comprising the recombinant HVT vectors. The present invention further provides methods of vaccination against a variety of avian pathogens and method of producing the recombinant HVT vectors.

Abstract: Provided herein are compositions of CD1280 binding proteins and a Hepatitis B virus core antigen (HBcAg) and/or a Hepatitis B virus E antigen (HBeAg), or antigenic fragments or mutants thereof, attached to the CD180 binding protein, and methods for using the compositions to treat or limit the development of hepatitis-B virus (HBV)-related disorders.

Abstract: The present invention concerns antibodies and antigen-binding fragments of antibodies which specifically bind to and neutralize Chikungunya virus (CHIKV) and which are engineered to develop therapeutics in order to treat CHIKV disease or prevent CHIKV infection. The invention also relates to pharmaceutical compositions comprising antibodies of the invention and the use of the antibodies for the prevention and treatment of CHIKV disease.

Abstract: Disclosed herein is an anti-DENV antibody, a pharmaceutical composition comprising the same, and uses thereof. According to embodiments of the present disclosure, the anti-DENV antibody comprises a heavy chain variable region and a light chain variable region, in which the heavy chain variable region comprises amino acid sequences of SEQ ID NOs: 1-3, and the light chain variable region comprises amino acid sequences of SEQ ID NOs: 5-7.

Abstract: Sequencing nucleic acids can identify variations associated with presence, susceptibility or prognosis of disease. However, the value of such information can be compromised by errors introduced by or before the sequencing process including preparing nucleic acids for sequencing. Blunting single-stranded overhangs on nucleic acids in a sample can introduce deamination-induced sequencing errors. The disclosure provides methods of identifying and correcting for such deamination-induced sequencing errors and distinguishing them from real sequence variations.

Abstract: Angiotensin II (AngII) has been strongly implicated in hypertension and its complications. Evidence suggests the mechanisms by which angiotensin II (AngII) elevates blood pressure and enhances cardiovascular remodeling and damage may be distinct. In vascular smooth muscle cells, a metaloproteinase ADAM17 mediates epidermal growth factor receptor (EGER) transactivation, which may be responsible for cardiovascular remodeling but not hypertension induced by AngII. Treatment with a human cross-reactive ADAM17 inhibitory antibody (A9B8) also prevented cardiovascular, remodeling and ER stress but not hypertension in C57Bl/6 mice infused with AngII. In vitro data further supported these findings. In conclusion, vascular ADAM17 mediates AngII-induced cardiovascular remodeling via EGFR activation independent of blood pressure regulation. ADAM17 presents a unique therapeutic target for antibodies such as A9B8 for the prevention of hypertensive complications.

Abstract: Polyclonal antibodies specific for serogroup X of N. meningitidis and uses thereof in diagnosis. The present invention is directed to polyclonal antibodies, specific for the capsular polysaccharides of Neisseria meningitidis serogroup X (NmX), wherein said antibodies are suitable for in vitro detection of Neisseria meningitidis serogroup X in biological fluids without culture. The invention also concerns said polyclonal antibodies in different diagnostic tests and methods, in order to detect Nm X. The invention discloses also a rapid diagnostic test for detecting NmX in a biological fluid, as well as a method for obtaining polyclonal antibodies useful for detecting NmX in biological fluids such as cerebrospinal fluid, serum and urine.

Abstract: An improved method for the manufacture of an oil-in water emulsion involves three procedures: (i) preparation of a preliminary emulsion; (ii) micro fluidization of the preliminary emulsion to reduce its droplet size; and (iii) filtration, of the microfluidized emulsion through a hydrophilic membrane. The emulsions are useful as vaccine adjuvants.

Abstract: Described herein are flavivirus virus-like particles (VLPs) that display on their surfaces antigenic flavivirus proteins. Also described are methods of making and using these VLPs.

Abstract: A non-replicating recombinant adeno-associated associated virus (rAAV) having an AAV capsid having packaged therein a vector genome which comprises AAV inverted terminal repeat sequences and at least one nucleic acid sequence encoding four different immunoglobulin regions (a), (b), (c) and (d) is provided. The rAAV-expressed immunoglobulins are useful for providing passive immunization against influenza A and influenza B. Also described herein are compositions containing the rAAV. Methods of vaccinating patients against influenza are provided.

Abstract: The present invention relates to novel peptidomimetic compounds that are capable of binding to and/or neutralizing influenza viruses, in particular influenza A viruses of phylogenetic group 1, and to pharmaceutical compositions comprising such compounds. The invention also relates to the use of the peptidomimetic compounds in the diagnosis, prophylaxis and/or treatment of influenza virus infections.

Abstract: The present invention provides a composition comprising at least two influenza A virus-neutralizing binding molecules that bind to an epitope in the stem region of influenza A virus hemagglutinin (HA) protein, the method comprising: i) a first binding molecule capable of neutralizing at least one influenza A virus subtype selected from the group consisting of H1, H2, H5 and H9; ii) a second binding molecule capable of neutralizing at least one influenza A virus subtype selected from the group consisting of H1, H3, H5, H7 and H9. The mixed composition of the present invention can effectively neutralize the multiple influenza subtypes of both phylogenetic group 1 and phylogenetic group 2 and can be used in combination with a chemical compound. Thus, the composition of the present invention is very useful for the prevention and treatment of a disease by influenza virus.

Abstract: Provided herein are, inter alia, methods for treating rhinosinusitis with P-glycoprotein inhibitors. A subject having rhinosinusitis is identified and then treated by administration to the subject an effective amount of a P-gp inhibitor. The subject having rhinosinusitis can be identified by one of skill in the art based on known methods, e.g., based on detection of the presence of symptoms, by endoscopy, or by computed tomography. The efficacy of the treatment can be monitored by methods known in the art, e.g., by monitoring symptoms, by endoscopy or computed tomography. The P-glycoprotein inhibitor can be delivered to the subject's nasal passage and sinuses by an inhalation device, by flushing, by spraying, or by an eluting implant surgically placed in the subject's nasal passage or sinuses. The P-glycoprotein inhibitor can also be administered in combination with one or both of a corticosteroid and an antibiotic.

Abstract: The present invention provides matched antibody pairs for the specific detection of one or more of the four dengue virus serotypes in a biological sample that may contain one or more of such dengue virus serotypes. Each matched antibody pair is capable of detecting not more than one serotype of dengue virus NS1 protein that may be present in the sample and will not cross react with other serotypes that may be present in the sample. Multiple matched pairs may be used to detect one or more dengue virus serotypes that may be present in a sample. Such matched pair antibodies, facilitate the development of confirmatory in vitro diagnostic tests such as sandwich immunoassays, that detect and distinguish the presence of one or more dengue virus serotypes in a biological sample, preferably a sample derived from human subject.

Abstract: This disclosure relates to peptide agents, e.g., antibodies and antigen-binding fragments thereof, that bind hemagglutinin protein of influenza viruses, and methods of their use.

Abstract: Disclosed are vaccine-derived neutralizing antibodies (NAbs) for CMV infections and small peptides which define precise recognition elements of the antigens by the NAbs. In certain embodiments, vaccine-derived NAbs may be produced by immunizing a subject with a gH/gL/UL128/UL130/UL131A pentameric glycoprotein complex (gH/gL-PC). In certain embodiments, vaccine-derived NAbs may have properties similar or identical to those of NAbs induced in a subject naturally infected with CMV. Native and non-native small peptides from UL128 and gH have been defined by mapping epitopes and deriving artificial sequences which are minimal recognition elements of vaccine-derived NAbs disclosed herein. These small peptides can be used to elicit vaccine-derived NAbs that prevent CMV entry into susceptible cell types and protect humans from infection and disease. Multivalent vaccines comprising these small peptides and/or epitopes are also disclosed.

Abstract: The invention relates to the identification of monoclonal HIV-1 neutralizing antibodies, such as, but not limited to, antibodies that bind to the CD4 binding site (CD4bs) of HIV-1 gp120, their recombinant expression and purification and uses. In certain aspects, the invention provides a pharmaceutical composition comprising anyone of the antibodies of the invention or fragments thereof or any combination thereof. In certain aspects the invention provides methods to treat or prevent HIV-1 infection in a subject comprising administering to the subject a pharmaceutical composition comprising any one of the inventive antibodies or fragments thereof.

Abstract: The invention provides human antibodies against rabies and methods of using the same.

Abstract: Monomeric and multimeric binding molecules that are capable of specifically binding to hemagglutinin (HA) of at least two influenza A virus strains, said strains including HA of two different HA subtypes from phylogenetic group 2; or capable of specifically binding to hemagglutinin (HA) of at least one influenza A virus strain from phylogenetic group 1 and at least one influenza A virus strain from phylogenetic group 2; or capable of specifically binding to hemagglutinin (HA) of at least one influenza B virus strain are provided. The binding molecules preferably are also capable of neutralizing at least two influenza A virus strains from phylogenetic group 2; or capable of neutralizing at least one influenza A virus strain from phylogenetic group 1 and at least one influenza A virus strain from phylogenetic group 2; or capable of specifically neutralizing at least one influenza B virus strain.

Abstract: The present invention provides recombinant herpesvirus of turkeys (HVT) vectors that contain and express antigens of avian pathogens, compositions comprising the recombinant HVT vectors and polyvalent vaccines comprising the recombinant HVT vectors. The present invention further provides methods of vaccination against a variety of avian pathogens and method of producing the recombinant HVT vectors.

Abstract: The present invention relates to immunogenic immune complexes, related compositions, and related methods. This invention addresses the above-described un-met need by providing an immune complex (IC) or immune complexes (ICs), which take advantages of Type II Fc receptor (FcR) interactions and signaling to elicit broader and more potent protective immune responses. In one aspect, the invention provides an immune complex comprising an antigenic agent and an isolated protein. The protein comprises an IgG Fc region and is capable of binding to a Type II Fc receptor. Preferably, the protein is an antibody or an Fc region-containing fragment thereof.

Abstract: The present invention provides, among other things, technologies and methodologies for detection, treatment, and/or prevention of influenza transmission and/or infection. The present invention also provides technologies for monitoring influenza variants for their potential to present a pandemic risk to humans.

Abstract: The present invention relates to a method for purifying an immunoglobulin, and more particularly, to a method for purifying an immunoglobulin, which comprises: dialyzing and concentrating an immunoglobulin-containing plasma protein fraction II paste; removing thrombotic substances from the dialyzed and concentrated fraction by a purification process using ceramic cation exchange resin; and performing elution while maintaining salt concentration at a constant level to maintain the polymer content of the immunoglobulin at a low level. When the immunoglobulin purification method according to the present invention is used, the efficiency with which impurities and thrombotic substances are removed can be increased and the polymer content of the immunoglobulin can be maintained, and thus a stable immunoglobulin with improved quality can be produced.

Abstract: Described is a reproducible, effective and scalable process for parvovirus production including characterization strategies, preferably production of H-1PV.

Abstract: The present invention provides: a modified FcRn-binding domain having an enhanced affinity for the Fc Receptor neonatal (FcRn) at neutral pH; an antigen-binding molecule comprising said FcRn-binding domain, which has low immunogenicity, high stability and form only a few aggregates; a modified antigen-binding molecule having an increased FcRn-binding activity at neutral or acidic pH without an increased binding activity at neutral pH for a pre-existing anti-drug antibody; use of the antigen-binding molecules for improving antigen-binding molecule-mediated antigen uptake into cells; use of the antigen-binding molecules for reducing the plasma concentration of a specific antigen; use of the modified FcRn-binding domain for increasing the total number of antigens to which a single antigen-binding molecule can bind before its degradation; use of the modified FcRn-binding domain for improving pharmacokinetics of an antigen-binding molecule; methods for decreasing the binding activity for a pre-existing anti-drug a

Abstract: This disclosure relates to novel peptide agents, e.g., antibodies and antigen-binding fragments thereof, that bind hemagglutinin protein of influenza viruses, and methods of their use.

Abstract: The present invention provides, among other things, antibody agents (e.g., antibodies, and/or antigen-binding fragments thereof) that bind to DV epitopes, as well as compositions containing them and methods of designing, providing, formulating, using, identifying and/or characterizing them. In some embodiments, provided antibody agents show significant binding to a plurality of DV serotypes. In some embodiments, provided antibody agents show significant binding to all four DV serotypes. Such antibody agents are useful, for example, in the prophylaxis, treatment, diagnosis, and/or study of DV.

Abstract: An antibody, or a binding fragment of the antibody, against H1N1 virus, includes a heavy chain variable region and a light chain variable region, wherein the heavy chain variable region contains complementarity determining regions (CDR) that have the amino acid sequences of SEQ ID NO: 5, SEQ ID NO: 6, and SEQ ID NO: 7; and wherein the light chain variable region contains complementarity determining regions that have the amino acid sequences of SEQ ID NO: 8, SEQ ID NO: 9, and SEQ ID NO: 10. A method for treating or preventing H1N1 infection in a subject includes administering to the subject the antibody or the binding fragment of the antibody.

Abstract: The present invention provides anti-influenza A virus antibodies effective at binding, neutralizing, and treating influenza A H7N9 virus, compositions comprising such antibodies, and methods of using the same.

Abstract: GB1 peptidic compounds that specifically bind to a hemagglutinin target protein, and libraries that include the same, as well as methods of making and using the same, are provided. Also provided are methods and compositions for making and using the compounds. Also provided are hemagglutinin mimics and fragments and methods of using the same, including methods of screening for GB1 peptidic compounds and methods of using conjugates the mimics as influenza A vaccines. Aspects of the invention include methods of screening libraries of L-peptidic compounds for specific binding to a D-peptidic hemagglutinin target protein. Once a L-peptidic compound has been identified that specifically binds to the D-peptidic hemagglutinin target protein, the D-enantiomer of the selected L-peptidic compound may be produced. In some embodiments, the D-enantiomer of the selected L-peptidic compound binds to, and in some instances, neutralizes influenza virus particles.

Abstract: The present invention relates to compositions and methods for the treatment of immunodeficiency (e.g., primary immunodeficiency disease). In particular, the invention provides human plasma immunoglobulin compositions containing select antibody titers specific for a plurality of respiratory pathogens, methods of identifying human donors and donor samples for use in the compositions, methods of manufacturing the compositions, and methods of utilizing the compositions (e.g., for prophylactic administration and/or therapeutic treatment (e.g., passive immunization (e.g., immune-prophylaxis))).

Abstract: The present invention provides antibodies (e.g., monoclonal antibodies, human antibodies, humanized antibodies, etc.), which bind to multiple influenza strains. Such antibodies are useful, for example, in the prophylaxis, treatment, diagnosis, and/or study of influenza.

Abstract: Described are binding molecules, e.g., human monoclonal antibodies, that bind to influenza virus comprising HA of the H3 subtype, e.g., H3N2, and have a broad neutralizing activity against such influenza virus. Described are polynucleotides encoding the binding molecules, their sequences and compositions comprising the binding molecules and methods of identifying or producing the binding molecules. The binding molecules can be used in the diagnosis, prophylaxis, and/or treatment of influenza virus H3N2 infection. The binding molecules may provide cross-subtype protection, such that infections with H3, H7, and/or H10-based influenza subtypes can be prevented and/or treated.

Abstract: Monoclonal antibodies directed against the influenza A virus are described, which have the advantageous and unpredicted property of being able to bind a plurality of subtypes of the influenza A virus. One preferred embodiment is the antibody designated as Fab28, which displays a neutralizing activity against a plurality of subtypes of the influenza A virus. Anti-idiotype antibodies directed against the monoclonal antibodies described herein, immunogenic or vaccine compositions comprising the monoclonal antibodies of the invention are also described, as well as therapeutic, prophylactic and diagnostic applications for the monoclonal antibodies described herein. The monoclonal antibodies can also be used for testing antibody preparations to be used as vaccines.

Abstract: Monoclonal antibodies directed against the influenza A virus are described, which have the advantageous and unpredicted property of being able to bind a plurality of subtypes of the influenza A virus. One preferred embodiment is the antibody designated as Fab28, which displays a neutralizing activity against a plurality of subtypes of the influenza A virus. Anti-idiotype antibodies directed against the monoclonal antibodies of the invention, immunogenic or vaccine compositions comprising the monoclonal antibodies of the invention are also described, as well as therapeutic, prophylactic and diagnostic applications for the monoclonal antibodies of the invention. The monoclonal antibodies of the invention can also be used for testing antibody preparations to be used as vaccines.

Abstract: The present invention relates to a binding molecule having influenza A virus-neutralizing activity derived from a human B cell, and the binding molecule having the influenza A virus-neutralizing activity, according to the present invention, is a binding molecule that is derived from a B cell that is selected from the blood of a patient infected with an influenza A virus, and has neutralizing activity against influenza A viruses, and thus is useful in preventing and treating disease derived from the influenza A virus, and can be useful in diagnosing the influenza A virus by using the binding molecule according to the present invention.

Abstract: The present invention relates to replication-competent Arteriviruses having a decreased DUB/deISGylating activity due to a mutation in the PLP2 domain of the non-structural protein nsp2, to their use as a medicament, their use as a vaccine and in prophylaxis, to vaccines comprising such Arteriviruses and to Arteriviral PLP2-ubiquitin complexes.

Abstract: A concentrated, immunoglobulin composition for treating subjects vaccinated against or infected with a pathogenic microorganism, is made by (a) selecting a population of individuals previously vaccinated against antigens associated with the pathogenic microorganism; (b) identifying very high titer individuals by determining the level of specific antibodies immunoreactive with the pathogenic microorganism in the blood of the individuals; (c) combining blood from the very high titer individuals; and (d) purifying and/or concentrating the product of step (c). A concentrated immunoglobulin composition can include specific antibodies immunoreactive with a pathogenic microorganism, wherein the titer of specific antibodies is at least 5 times higher than the average titer of specific antibodies of a population of individuals previously vaccinated against antigens associated with the pathogenic microorganism. The composition has a relatively high protein concentration and a low percentage of protein aggregates.

Abstract: GB1 peptidic compounds that specifically bind to a hemagglutinin target protein, and libraries that include the same, as well as methods of making and using the same, are provided. Also provided are methods and compositions for making and using the compounds. Also provided are hemagglutinin mimics and fragments and methods of using the same, including methods of screening for GB1 peptidic compounds and methods of using conjugates the mimics as influenza A vaccines. Aspects of the invention include methods of screening libraries of L-peptidic compounds for specific binding to a D-peptidic hemagglutinin target protein. Once a L-peptidic compound has been identified that specifically binds to the D-peptidic hemagglutinin target protein, the D-enantiomer of the selected L-peptidic compound may be produced. In some embodiments, the D-enantiomer of the selected L-peptidic compound binds to, and in some instances, neutralizes influenza virus particles.

Abstract: Novel nanoparticle fusion proteins comprising proteins or peptides fused to Dps (DNA-binding protein from starved cells) proteins are provided which bring forth distinct advantages for development of new and improved vaccines, diagnostic tests, and other biomedical products.

Abstract: Monoclonal antibodies directed against the influenza A virus are described, which have the advantageous and unpredicted property of being able to bind a plurality of subtypes of the influenza A virus. One preferred embodiment is the antibody designated as Fab28, which displays a neutralizing activity against a plurality of subtypes of the influenza A virus. Anti-idiotype antibodies directed against the monoclonal antibodies of the invention, immunogenic or vaccine compositions comprising the monoclonal antibodies of the invention are also described, as well as therapeutic, prophylactic and diagnostic applications for the monoclonal antibodies of the invention. The monoclonal antibodies of the invention can also be used for testing antibody preparations to be used as vaccines.

Abstract: The present invention relates in part to amino acid sequences that are directed against and/or that can specifically bind to an envelope protein of a virus, as well as to compounds or constructs, and in particular proteins and polypeptides, that comprise or essentially consist of one or more such amino acid sequences.

Abstract: The present invention relates to functional heavy chain antibodies, functional single domain heavy chain antibodies, functional VH domains, or functional fragments thereof comprising an amino acid which is neither a charged amino acid nor a C at position 45, and comprising an amino acid at position 103 independently chosen from the group consisting of R, G, K, S, Q, L, and P, and optionally an amino acid at position 108 independently chosen from the group consisting of Q, L and R, said positions determined according to the Kabat numbering.

Abstract: The present invention provides a novel infectious cDNA clone of porcine reproductive and respiratory syndrome virus (PRRSV), particularly for PRRSV strain VR2385; an improved DNA-launched reverse genetics system for PRRSV; infectious chimeric PRRSV viruses generated through DNA shuffling; modified live-attenuated virus vaccines (MLV) using DNA shuffled chimeric viruses; chimeric viral proteins produced through shuffled chimeric viruses; PRRSV antigens and subunit vaccines based on shuffled chimeric viral proteins; and method of producing broadly protective PRRSV vaccines using DNA shuffling techniques.

Abstract: The present invention relates to compositions and methods for the treatment of immunodeficiency (e.g., primary immunodeficiency disease). In particular, the invention provides human plasma immunoglobulin compositions containing select antibody titers specific for a plurality of respiratory pathogens, methods of identifying human donors and donor samples for use in the compositions, methods of manufacturing the compositions, and methods of utilizing the compositions (e.g., for prophylactic administration and/or therapeutic treatment (e.g., passive immunization (e.g., immune-prophylaxis))).