Abstract: The present disclosure relates to protein molecules that specifically bind to CD123, which may have at least one humanized or human CD123-binding domain. Such molecules are useful for the treatment of cancer. The protein molecule binding to CD123 may have a second binding domain that binds to another target. In one embodiment, multi-specific polypeptide molecules bind both CD123-expressing cells and the T-cell receptor complex on T-cells to induce target-dependent T-cell cytotoxicity, activation, and proliferation. The disclosure also provides pharmaceutical compositions comprising the CD123-binding polypeptide molecules, nucleic acid molecules encoding these polypeptides and methods of making these molecules.

Abstract: The present disclosure relates to, inter alia, a method of treating age-related macular degeneration (AMD) in a patient, comprising administering an effective amount of a C5 inhibitor or a C5a inhibitor.

Abstract: The present invention provides an anti-LAG-3 antibody capable of repeated administration even to animals other than rat. An anti-LAG-3 antibody comprising (a) a light chain comprising a light chain variable region containing CDR1 having the amino acid sequence of QSLLDSDGNTY (SEQ ID NO: 16), CDR2 having the amino acid sequence of SVS and CDR3 having the amino acid sequence of MQATHVPFT (SEQ ID NO: 17) and the light chain constant region of an antibody of an animal other than rat; and (b) a heavy chain comprising a heavy chain variable region containing CDR1 having the amino acid sequence of GFDFDTYP (SEQ ID NO: 18), CDR2 having the amino acid sequence of ITIKTHNYAT (SEQ ID NO: 19) and CDR3 having the amino acid sequence of NREDFDY (SEQ ID NO: 20) and the heavy chain constant region of an antibody of an animal other than rat. A pharmaceutical composition comprising the above anti-LAG-3 antibody as an active ingredient. A method for preparing the above anti-LAG-3 antibody is also provided.

Abstract: The present invention relates to polypeptide variants having alpha-amylase activity and an improved property, such as improved specific activity, as compared to the parent polypeptide. The invention further relates to use of the polypeptide variants, compositions comprising the polypeptide variants, and methods of producing the polypeptide variants.

Abstract: A method of producing an antibody fragment for a target antigen includes administering an immunizing mixture containing the target antigen to a cartilaginous fish for at least two times; collecting a blood sample from the cartilaginous fish; extracting RNAs from the blood sample; subjecting said RNAs to reverse transcription to obtain a complementary DNA, and optionally amplifying the cDNA to obtain a mixture of amplified cDNAs followed by purification. Also covered are methods of producing an antibody fragment from a shark; antibody fragments obtained from the method; a kit comprising antibody fragments; and methods of determining the presence and/or amount of a target antigen in a sample.

Abstract: The present invention relates to alpha-amylase variants. The present invention also relates to polynucleotides encoding the variants; nucleic acid constructs, vectors, and host cells comprising the polynucleotides; and methods of using the variants.

Abstract: The present invention provides glycated Amadori products of the CD59 peptide and fragments thereof to be used as tools and among methods for the diagnosis and prognosis of pre-diabetes and diabetes. Certain aspects of the invention include glycated Amadori products of CD59 and fragments thereof to be used for the generation of antibodies and antibody fragments. Still other aspects of the invention include methodologies for the preparation of glycated Amadori products of CD59, fragments thereof, the inventive antibodies, and antibody fragments.

Abstract: This invention relates to isolated antibodies which recognize the exosite 1 epitope of thrombin and selectively inhibit thrombin without promoting bleeding. These antibody molecules may be useful in the treatment and prevention of thrombosis, embolism and other conditions mediated by thrombin.

Abstract: The present disclosure relates to antibodies that bind human chitinase-3-like protein 1 (CHI3L1) and uses thereof. In aspects, the antibodies are useful in compositions and methods for detecting and/or treating nonalcoholic steatohepatitis (NAFLD) or nonalcoholic fatty liver disease (NASH) in a subject, as well as subsequent complications of untreated progression in the liver of a subject, such as liver cirrhosis and/or a hepatocellular carcinoma.

Abstract: The present disclosure provides isolated binding molecules that bind to and blocks PD-L1, vectors comprising a nucleic acid molecules encoding an amino acid sequence of the binding molecules, host cells containing the vectors, methods of making the binding molecules, pharmaceutical compositions containing the binding molecules, and methods of using such antibodies, antibody fragments and derivatives and polypeptides, including methods of treating a disease requiring stimulation of immune responses including cancer.

Abstract: The present invention relates to methods and compositions for modulating glycosylation profile, such as the galactosylation profile, of recombinant proteins expressed by mammalian host cells during the cell culture process by supplementing cell culture media with a peracetyl galactose.

Abstract: Provided herein are anti-Factor IX Padua binding constructs, e.g., antibodies and antigen-binding fragments thereof. Related polypeptides, conjugates and kits are also provided. The inventions may be used in methods of detecting Factor IX Padua in a sample.

Abstract: The present disclosure provides humanized and affinity matured antibodies (mAbs) and fragments thereof that specifically bind to CD79 with high affinity. The anti-CD79 mAbs and fragments thereof can be used to treat antibody-associated conditions, including autoimmune diseases, allergies, transplant rejection, or immune-mediated rejection of a therapeutics optionally in combination with an additional therapeutic agent. Furthermore, the anti-CD79 mAbs and fragments thereof can be used for diagnostic purposes, including to detect CD79 cells in biological samples and to diagnose B-cell associated disorders.

Abstract: The invention relates to a viral expression construct and related viral vector and composition and to their use wherein the construct and vector comprise elements a) and b): a) a nucleotide sequence encoding an insulin operably linked to a first promoter, b) a nucleotide sequence encoding a glucokinase operably linked to a second promoter and the viral expression construct and related viral vector comprise at least one of elements c), d) and e): c) the first and the second promoters are positioned in reverse orientation within the expression construct, d) the first and the second promoters are positioned in reverse orientation within the expression construct and are located adjacent to each other and e) the first promoter is a CMV promoter, preferably a mini CMV promoter.

Abstract: The invention is directed to antibody compositions that specifically bind to polycyclic aromatic hydrocarbons (PAHs) and kits encompassing the same.

Abstract: Uses of a dual V region antibody-like protein or a fragment of a dual V region antibody-like region.

Abstract: The present invention describes a simple purification process for recombinant human serum albumin. The process results in highly purified protein with limited number of purification steps. The broth containing human albumin is clarified by centrifugation and microfiltration, diafiltered and captured by cation exchange chromatography by a process that allows 140-230 mg of albumin to be captured per ml of resin. Product related impurities are removed by hydrophobic interaction chromatography, optimised to allow 87-97% recovery in flow through mode. The final series of processes are so combined that there is easy transition from one step to the next with minimal interventions and adjustments. The entire process of purification is completed within two days from harvest to final product. Thus a cost-effective process with improved recovery of protein at each step is developed. The purified human serum albumin is analyzed for purity and shows physicochemical characteristics that are similar to standard albumin.

Abstract: The present invention relates to a modified IgG4 Fc fragment useful as a drug carrier. When the modified IgG4 Fc fragment of the present invention is combined with an arbitrary drug, the resulting drug conjugate can minimize the effector functions of the IgG4 Fc and the chain exchange with in vivo IgG while maintaining in vivo activity and improving in vivo duration of the drug conjugate.

Abstract: The present disclosure relates to compositions, for treating interleukin 5 (IL-5) mediated diseases, and related methods.

Abstract: The present invention discloses a method for targeting maytansinoids to a selected cell population, the method comprising contacting a cell population or tissue suspected of containing the selected cell population with a cell-binding agent maytansinoid conjugate, wherein one or more maytansinoids is covalently linked to the cell-binding agent via a non-cleavable linker and the cell-binding agent binds to cells of the selected cell population.

Abstract: The present invention provides method for increasing the percentage of monomer in a composition of recombinantly expressed antibody molecules characterised in that the antibody molecule comprises at least one Fv with specificity for an antigen of interest comprising one VH and one VL wherein said VH and VL are connected directly or indirectly via one or more linkers and are stabilised by a disulfide bond therebetween, said method comprises a) a thermal conversion step of holding the composition comprising the antibody molecule at a temperature in the range 30 to 60° C. for a period of at least 1 hour, wherein step a) is performed in the presence of a reducing agent or after treatment with a reducing agent.

Abstract: The present invention provides anti-CD115 monoclonal antibodies and related compositions, which may be used in any of a variety of therapeutic and diagnostic methods for the treatment of cancer, autoimmune, and other diseases.

Abstract: The present invention provides anti-CD115 monoclonal antibodies and related compositions, which may be used in any of a variety of therapeutic and diagnostic methods for the treatment of cancer, autoimmune, and other diseases.

Abstract: Cancers of different cellular or tissue origins express different ENOX2 cancer isoforms or combinations of isoforms and shed these proteins into the circulation. Herein are disclosed methods both for cancer detection and diagnosis of particular origin, based on the patterns and molecular weights of the isoforms which allow the identification of the cell type and or tissue of origin of the neoplasm. Relative ENOX2 amounts are proportional to tumor burden and provide a reliable measure of response to therapy and disease progression. Also provided is the amino acid sequence to which the scFv antibodies bind as the molecular basis for the specificity of the test.

Abstract: The present invention relates to processes for producing fermentation products from starch-containing material, wherein an alpha-amylase and a thermostable hemicellulase is present and/or added during liquefaction. The invention also relates to compositions suitable for use in processes of the invention.

Abstract: The present invention relates to blocking, inhibiting, reducing, antagonizing or neutralizing the activity of IL-17A and IL-17F. IL-17A and IL-17F are cytokines that are involved in inflammatory processes and human disease. The present invention includes antibodies that bind both IL-17A and IL-17F, as well as methods of using the same in inflammation.

Abstract: The present invention relates to new methods and processes for culturing mammalian cells with the addition of phenolic antioxidants. Performance of the cell culturing methods and processes in their various aspects result in a higher viable cell density and higher protein titer.

Abstract: Recombinant bacterial cells are provided that comprise a stable non-canonical amino acid translation pathway. In some aspects, the bacteria comprise nucleic acids encoding a non-canonical amino acid translation pathway (e.g., a tRNA for incorporation of a non-canonical amino acid, such selenocysteine); a marker polypeptide that includes the non-canonical amino acid. Recombinant tRNA and selection marker coding sequences are likewise provided.

Abstract: Disclosed herein is a phage-displayed single-chain variable fragment (scFv) library, that comprised a plurality of phage-displayed scFvs characterized with (1) a specific CS combination; (2) a specific distribution of aromatic residues in each CDR; and (3) a specific sequence in each CDR. The present scFv library could be used to efficiently produce different antibodies with binding affinity to different antigens. Accordingly, the present disclosure provides a potential means to generate different antigen-specific antibodies promptly in accordance with the need in experimental researches and/or clinical applications.

Abstract: The present disclosure relates to compositions and methods for modulating T-cell mediated immune response in a subject in need thereof. The method includes administering to the subject an effective amount of a CD112R protein, a fusion polypeptide, a complex including CD112R and a second protein, or an anti-CD112R antibody of the present disclosure.

Abstract: The present invention describes a simple purification process for recombinant human serum albumin. The process results in highly purified protein with limited number of purification steps. The broth containing human albumin is clarified by centrifugation and microfiltration, diafiltered and captured by cation exchange chromatography by a process that allows 140-230 mg of albumin to be captured per ml of resin. Product related impurities are removed by hydrophobic interaction chromatography, optimized to allow 87-97% recovery in flow through mode. The final series of processes are so combined that there is easy transition from one step to the next with minimal interventions and adjustments. The entire process of purification is completed within two days from harvest to final product. Thus a cost-effective process with improved recovery of protein at each step is developed. The purified human serum albumin is analyzed for purity and shows physicochemical characteristics that are similar to standard albumin.

Abstract: Provided herein are multifunctional heteromultimer proteins. In specific embodiments is a heteromultimer comprising: at least two polypeptide constructs, each polypeptide construct comprising at least one cargo polypeptide attached to a transporter polypeptide, said transporter polypeptides derived from a monomeric native protein such that said monomeric constructs associate to form the heteromultimer and said transporter polypeptides associate to form a quasi-native structure of the monomeric native protein or analog thereof. These therapeutically novel molecules encompass heteromultimers comprising constructs that function as scaffolds for the conjugation or fusion of therapeutic molecular entities (cargo polypeptides) resulting in the creation of bispecific or multivalent molecular species. Provided herein is a method for creation of bispecific or multivalent molecular species.

Abstract: Disclosed herein is a phage-displayed single-chain variable fragment (scFv) library, that comprised a plurality of phage-displayed scFvs characterized with (1) a specific CS combination; (2) a specific distribution of aromatic residues in each CDR; and (3) a specific sequence in each CDR. The present scFv library could be used to efficiently produce different antibodies with binding affinity to different antigens. Accordingly, the present disclosure provides a potential means to generate different antigen-specific antibodies promptly in accordance with the need in experimental researches and/or clinical applications.

Abstract: This invention relates in part to plant breeding and herbicide tolerant plants. This invention includes a novel aad-1 transformation event in corn plants comprising a polynucleotide sequence, as described herein, inserted into a specific site within the genome of a corn cell. In some embodiments, said event/polynucleotide sequence can be “stacked” with other traits, including, for example, other herbicide tolerance gene(s) and/or insect-inhibitory proteins. Additionally, the subject invention provides assays for detecting the presence of the subject event in a sample (of corn grain, for example). The assays can be based on the DNA sequence of the recombinant construct, inserted into the corn genome, and on the genomic sequences flanking the insertion site. Kits and conditions useful in conducting the assays are also provided.

Abstract: The present invention relates to methods for screening and producing polypeptides that immunospecifically bind to an antigen, which: polypeptides comprise binding domains that are derived from rabbit immunoglobulin. Using rabbit antibody heavy-chain or light-chain scaffolds, the methods of the invention allow identification of novel CDR loops and framework regions that confer enhanced stability and/or affinity to isolated immunoglobulin variable domains, in particular, relative to those derived from rodent antibodies. The enhanced stability and/or affinity of the variable domains of the invention permit their use in the production research tools or therapeutic immunospecific polypeptides, including single domain immunospecific polypeptides, i.e., comprising one of a VH or VL domain.

Abstract: The present invention provides an aminoalcohol together with, as necessary, at least one selected from the group consisting of: at least one compound selected from the group consisting of urea and a urea derivative; a nonionic detergent; and sucrose to provide a biological material having an excellent light-transmitting property. The present invention provides a technique that allows a high-throughput observation of gene expression/localization or cell morphology in tissue at an whole-tissue level.

Abstract: The present teachings relate to methods, systems, and kits for the preparation, purification and/or analysis of a glycan or glycoconjugate, and specifically to a magnetic bead based sample preparation protocol that can enable full automation and reduced sample preparation time relative to current methods of glycoanalysis. In some aspects, the sample preparation protocol can provide for glycoconjugate capture, glycan release, fluorescent derivatization, and glycan purification for subsequent capillary electrophoresis, liquid chromatography, or other glycoanalytical method without requiring time-consuming sample preparation steps such as centrifugation or vacuum-centrifugation.

Abstract: Disclosed are methods and kits for early detection of antigen exposure through the presence or absence of antigen-specific antibodies.

Abstract: The present invention provides a method of preparing zearalenone hydrolase, including the step of culturing a yeast cell carrying a gene encoding a zearalenone hydrolase in a medium to express a protein of the zearalenone hydrolase, wherein the medium contains 20 to 25% molasses by weight. This method provides a new strategy to efficiently prepare zearalenone hydrolase at low expenses.

Abstract: The present invention provides an aminoalcohol together with, as necessary, at least one selected from the group consisting of: at least one compound selected from the group consisting of urea and a urea derivative; a nonionic detergent; and sucrose to provide a biological material having an excellent light-transmitting property. The present invention provides a technique that allows a high-throughput observation of gene expression/localization or cell morphology in tissue at an whole-tissue level.

Abstract: Provided herein are antigen-binding constructs such as antibodies that bind to the RRM-1 domain of TDP-43. The antigen-binding constructs are capable of blocking the interaction of TDP-43 with NF-?B in cells. Also provided herein are method of using the antigen-binding constructs in the treatment of diseases associated with TPD-43 proteinopathy, such as amyotrophic lateral sclerosis (ALS), frontotemperal lobar degeneration (FTLD), Lewy body disease and motor neuron disease.

Abstract: Methods for producing heterologous proteins are disclosed. In particular, the present disclosure provides improved methods of producing desired proteins, including multi-subunit proteins such as antibodies, with a higher yield and improved purity. In exemplary embodiments, the transformed cells are a yeast, e.g., methylotrophic yeast such as Pichia pastoris.

Abstract: Antibodies, antigen-binding proteins and Fc-fusion proteins that comprise recombinant polypeptides containing a chimeric heavy chain constant region sequence are provided that bind to certain Fc receptors however have reduced effector functions. Methods of making constructs for expression of such chimeric Fc-containing antibodies, antigen-binding proteins and Fc-fusion proteins in cell systems, and methods of producing and isolating the chimeric Fc-containing proteins are provided.

Abstract: This disclosure generally relates to antibodies or antibody fragments which specifically bind to M-CSF. In particular antibodies and antibody fragments are disclosed which bind to M-CSF and which inhibit binding of M-CSF to the M-CSF receptor with an IC50 of 10 pM or less. The invention also relates to nucleic acids, vectors and host cells capable of expressing the antibodies or fragments thereof of the invention, pharmaceutical compositions comprising the antibodies or fragments thereof and uses of said antibodies or fragments thereof and compositions for treatment of specific diseases.

Abstract: The present invention relates to blocking, inhibiting, reducing, antagonizing or neutralizing the activity of IL-17A and IL-17F. IL-17A and IL-17F are cytokines that are involved in inflammatory processes and human disease. The present invention includes antibodies that bind both IL-17A and IL-17F, as well as methods of using the same in inflammation.

Abstract: In the course of the present invention, it was discovered that one could regulate association between polypeptides by modifying amino acid residues that form the interface during the association to amino acids carrying the same type of charge. In this context, the present invention enables efficient formation of heterologous molecules. For example, the present invention can be suitably applied to the preparation of bispecific antibodies.

Abstract: The present invention provides methods and compositions for reducing lactate production and increasing polypeptide production in cultured cells. In one aspect, the invention provides a method comprising culturing cells expressing a) a small interfering RNA (siRNA) specific for a lactate dehydrogenase (LDH) and b) an siRNA specific for a pyruvate dehydrogenase kinase (PDHK). In another aspect, the invention provides cultured cells or vectors comprising an siRNA specific for a LDH and an siRNA specific for a PDHK.

Abstract: The present invention relates to novel endogenous variants of erythropoietin (EPO) and their use for treatment or prevention of a condition associated with tissue damage due to cell death (apoptosis, necrosis) and inflammation, in particular for neuroprotection, e.g. treatment of acute (for example stroke) and chronic disease (for example ALS) of the nervous system.

Abstract: The invention relates to a method for the production of a Factor VIII polypeptide, the method comprising the steps of a) culturing a mammalian cell expressing a Factor VIII polypeptide under conditions for expression of said Factor VIII polypeptide, said culturing conditions involving a cell culture medium comprising a C2-domain ligand, and b) isolating the expressed Factor VIII polypeptide from the mammalian cell by suitable means.

Abstract: The present invention relates to discontinuous fed batch cell culturing of mammalian cells (more specific CHO cells) with the use of alternating bioreactors in combination with discontinuous separation of biomass from biological substance (more specific monoclonal antibodies) and waste components.