Abstract: The present invention relates to a method of purifying albumin-fusion proteins to reduce the level of oxidation of susceptible amino acid residues. The method comprises an affinity matrix chromatography step and an anion exchange chromatography step. The purified albumin-fusion proteins have low levels of oxidation and retain their enhanced half-life in vivo and its bioactivity. In some embodiments, the albumin-fusion protein comprises a scaffold, such as human Tenascin C scaffold. Compositions comprising the albumin-fusion protein are further disclosed.

Abstract: The present invention relates to Relaxin fusion polypeptides, in particular to Relaxin 2 fusion polypeptides and uses thereof. Thus, the invention provides Relaxin fusion polypeptides, nucleic acid molecules, vectors, host cells, pharmaceutical compositions and kits comprising the same and uses of the same including methods of treatment. The polypeptides and compositions of the invention may be useful, in particular, in the treatment of cardiovascular diseases, for example for the treatment of heart failure.

Abstract: Provided herein are methods of preventing and treating polybacterial infections comprising administering an effective amount of an antibody or antigen-binding fragment thereof that specifically binds to an epitope produced by at least one of the bacterium in the polybacterial infection. For example, an antibody that specifically binds to Staphylococcus aureus alpha toxin can be administered to a patient with a polybacterial infection comprising Staphylococcus aureus and Pseudomonas aeruginosa to inhibit the growth of Pseudomonas aeruginosa.

Abstract: The present invention relates to antibodies and antigen binding fragments thereof that bind the extracellular domain of the HER3 receptor and inhibit various HER3 receptor related functions via ligand-dependent and/or ligand-independent mechanisms. Also provided are compositions with increased half-life. In addition, the invention provides compositions and methods for diagnosing and treating diseases associated with HER3 mediated signal transduction.

Abstract: This application provides a method of using aptamers to determine the presence of HCP's in a recombinant protein preparation, and provides methods of preparing a plurality of aptamers for use in the method of detecting a plurality of HCP's in a recombinant protein preparation. In accordance with the description, a method of determining the presence or absence of a plurality of HCP's in a recombinant protein preparation comprises: providing a recombinant protein preparation; providing a final pool of aptamers; combining the recombinant protein preparation with the final pool of aptamers; and determining the presence or absence of a plurality of HCP's.

Abstract: Antibodies and antigen binding fragments thereof directed against Staphylococcus aureus (S. aureus) surface determinant antigens and secreted toxins are disclosed. Methods of detecting, diagnosing and treating S. aureus using the antibodies and antigen binding fragments thereof are also provided.

Abstract: The invention provides a method for removing multimers from a preparation of recombinant polyclonal antibodies (rpAbs) while maintaining the ratio of monomers within a narrow range. The invention provides a method of separating recombinant polyclonal antibody multimers with minimal separation of monomers comprising subjecting a mixture comprising a plurality of monoclonal antibodies to at least one separation process selected from the group consisting of multi-modal chromatography, apatite chromatography, and hydrophobic interaction chromatography thereby producing an antibody monomer preparation that is substantially free of multimers.

Abstract: Disclosed herein is a method for producing a recombinant polypeptide in a mammalian cell culture in which the mammalian cells have a modified microRNA activity level. In one embodiment, a microRNA activity level is increased. In another embodiment, a microRNA activity level is decreased. In a more particular embodiment, the mammalian cells have a reduced miRNA-let-7a activity level.

Abstract: The disclosure provides methods for treating a subject having a type I IFN-mediated disease or disorder comprising administration of a fixed does of an anti-interferon alpha receptor antibody. The disclosure also provides methods for suppressing a type I interferon (IFN) gene signature (GS) in a subject. In addition, the disclosure provides methods of prognosing or monitoring disease progression in a subject having a type I IFN-mediated disease or disorder, methods of predicting a dosage regimen, methods of identifying a candidate therapeutic agent, methods of identifying a patient as a candidate for a therapeutic agent, and methods of designating a personalized therapy.

Abstract: Methods are provided for producing a plurality of antibody species in a single animal, comprising delivering a plurality of antigen species to a single animal, where each antigen species is delivered to the animal at an anatomically distinct location. Also provided are methods for generating an immune response in an animal, where each antigen species is delivered to the animal at an anatomically distinct location, under conditions in which the animal produces a plurality of antibody species, where each antibody species specifically binds to a different antigen species among the plurality of antigen species.

Abstract: Systems, methods, and apparatus for managing patients in need of a predetermined pharmaceutical that requires preauthorization based upon patient clinical data are provided. Prescription information is obtained for each respective patient. Such information includes an identity of the patients and amounts of the pharmaceutical that has been prescribed to the patients. Further, clinical information associated with each patient is received. The clinical information one or more determinants that each contributes to providing a basis for authorizing or denying patient coverage for the pharmaceutical. At least one determinant in the one or more determinants is not a standardized code. Coverage for a patient for the predetermined pharmaceutical is requested by transmitting the prescription and clinical information to a specialty pharmaceutical distributor at a remote location.

Abstract: The present invention relates to a method of reducing the numbers of eosinophils in a human subject comprising administration to a subject an IL-5R binding molecule that comprises (a) a region that specifically binds to the IL-5R and (b) an immunoglobulin Fc region. In a specific embodiment, a method of the invention reduces the number of eosinophils in blood, bone marrow, gastrointestinal tract (e.g. esophagus, stomach, small intestine and colon), or lung.

Abstract: The present invention provides fibronectin type III (Fn3)-based multimeric scaffolds that specifically bind to one or more specific target antigen. The invention further provides bispecific Fn3-derived binding molecules that bind to two or more target antigens simultaneously, fusions, conjugates, and methods to increase the stability of Fn3-based binding molecules. Furthermore, the present invention is related to a prophylactic, therapeutic or diagnostic agent, which contains Fn3-based multimeric scaffolds.

Abstract: Provided are human serum albumin (HSA) compositions with improved properties over native HSA.

Abstract: The present invention provides liquid formulations of SYNAGIS® or an antigen-binding fragment thereof that immunospecifically bind to a respiratory syncytial virus (RSV) antigen, which formulations exhibit stability, low to undetectable levels of aggregation, and very little to no loss of the biological activities of SYNAGIS® or an antigen-binding fragment thereof, even during long periods of storage. In particular, the present invention provides liquid formulations of SYNAGIS® or an antigen-binding fragment thereof which immunospecifically binds to a RSV antigen, which formulations are substantially free of surfactant, inorganic salts, and/or other common excipients. Furthermore, the invention provides method of preventing, treating or ameliorating symptoms associated with RSV infection utilizing liquid formulations of the present invention.

Abstract: The present invention relates to recombinant bovine parainfluenza virus (bPIV) cDNA or RNA which may be used to express heterologous gene products in appropriate host cell systems and/or to rescue negative strand RNA recombinant viruses that express, package, and/or present the heterologous gene product. The chimeric viruses and expression products may advantageously be used in vaccine formulations including vaccines against a broad range of pathogens and antigens.

Abstract: The present invention provides recombinant respiratory syncytial viruses that have an attenuated phenotype and that comprise one or more mutations in the viral P, M2-1 and/or M2-2 proteins, as well as live attenuated vaccines comprising such viruses and nucleic acids encoding such viruses. Recombinant RSV P, M2-1 and M2-2 proteins are described. Methods of producing attenuated recombinant RSV, and methods of quantitating neutralizing antibodies that utilize recombinant viruses of family Paramyxoviridae, are also provided.

Abstract: The invention relates to targeted binding agents against DLL4 and uses of such agents. More specifically, the invention relates to fully human monoclonal antibodies directed to DLL4. The described targeted binding agents are useful in the treatment of diseases associated with the activity and/or overproduction of DLL-4 and as diagnostics.

Abstract: This invention relates to a human antibody which contains the one CDR from each variable heavy and variable light chain of at least one murine monoclonal antibody, against respiratory syncytial virus which is MAb1129 and the use thereof for the prevention and/or treatment of RSV infection.

Abstract: The present invention provides stable liquid formulations comprising chimeric and humanized versions of anti-CD 19 mouse monoclonal antibodies that may mediate ADCC, CDC, and/or apoptosis for the treatment of B cell diseases and disorders.