Abstract: In one non-limiting embodiment, the present disclosure relates to lyophilized formulations containing an IL-31 antagonist (for example, an anti-IL-31RA antibody) as an active ingredient, the lyophilized formulations further containing arginine and/or a salt thereof and sucrose and/or trehalose. In another non-limiting embodiment, the present disclosure relates to solution formulations containing an IL-31 antagonist as an active ingredient, the solution formulations further containing arginine and/or a salt thereof.

Abstract: The inventors produced substances that neutralize the activity of a bispecific antibody having an activity of functionally substituting for FVIII, and undertook the construction of methods for measuring the reactivity of FVIII that can ensure accuracy even in the presence of this bispecific antibody. As a result, the inventors discovered that in APTT-based one-stage clotting assay, FVIII activity in the plasma of a hemophilia A patient can be evaluated accurately, and also that in APTT-based Bethesda assay, FVIII inhibitor titer in the plasma of a hemophilia A patient carrying a FVIII inhibitor can be evaluated accurately.

Abstract: It is intended to provide a method for efficiently and stably producing a heteromultimer by incubating homo variants of plural types of heavy chain constant region-containing polypeptides differing in antigen-binding activity under a reducing condition that reorganize the inter-polypeptide disulfide bond between cysteine residues outside of core hinge regions. A feature of the production method of the present invention is that amino acid residues in the core hinge regions do not form any disulfide bond.

Abstract: The present inventors have successfully prepared an antibody Fc region dimer that has binding activity against each of an antigen and Fc?R, but does not bind to the antigen and the Fc?R at the same time, and a polypeptide comprising the Fc region dimer. The present invention enables the preparation of a multispecific binding polypeptide capable of avoiding an adverse reaction that may be caused by its binding to an antigen and Fc?R at the same time. Thus, the present invention provides a polypeptide suitable as a drug.

Abstract: The present invention provides a method of producing a recombinant antibody efficiently and at low cost. Disclosed is a method of producing an antibody or a fragment thereof, comprising allowing a cell to produce the antibody or the fragment, wherein the cell contains a larger number of copies of an exogenous DNA encoding the light chain or a fragment thereof of the antibody than the number of copies contained in the cell of an exogenous DNA encoding the heavy chain or a fragment thereof of the antibody. The present invention also provides a recombinant vector comprising one copy of a DNA encoding the heavy chain or a fragment thereof of an antibody and two or more copies of a DNA encoding the light chain or a fragment thereof of the antibody; and a transformant.

Abstract: Herein is reported a method for the production of an immunoglobulin comprising the following steps: a) providing a eukaryotic cell comprising a nucleic acid encoding the immunoglobulin, b) cultivating the eukaryotic cell in a cultivation medium wherein the amount of glucose available in the cultivation medium per time unit is kept constant and limited to less than 80% of the amount that could maximally be utilized by the cells in the cultivation medium per time unit, and c) recovering the immunoglobulin from the culture.

Abstract: The disclosure provides multispecific antigen-binding molecules that comprise a first antigen-binding moiety and a second antigen-binding moiety, each of which is capable of binding to CD3 and CD137, but does not bind to CD3 and CD137 at the same time; and a third antigen-binding moiety that is capable of binding to DLL3, preferably human DLL3, which induce T-cell dependent cytotoxity more efficiently whilst circumventing adverse toxicity concerns or side effects that other multispecific antigen-binding molecules may have. The present invention provides multispecific antigen-binding molecules and pharmaceutical compositions that can treat various cancers, especially those associated with DLL3, by comprising the antigen-binding molecule as an active ingredient.

Abstract: The present invention provides a method of producing a recombinant antibody efficiently and at low cost. Disclosed is a method of producing an antibody or a fragment thereof, comprising allowing a cell to produce the antibody or the fragment, wherein the cell contains a larger number of copies of an exogenous DNA encoding the light chain or a fragment thereof of the antibody than the number of copies contained in the cell of an exogenous DNA encoding the heavy chain or a fragment thereof of the antibody. The present invention also provides a recombinant vector comprising one copy of a DNA encoding the heavy chain or a fragment thereof of an antibody and two or more copies of a DNA encoding the light chain or a fragment thereof of the antibody; and a transformant.

Abstract: The present invention aims to provide a high-dose formulation with improved properties of a pharmaceutical composition comprising a poorly soluble basic agent, particularly a compound represented by formula (I) or a salt thereof. The problem described above can be solved by providing a pharmaceutical composition comprising the compound represented by formula (I) or a salt thereof, a surfactant, and a basic substance.

Abstract: The solid dispersion of the present invention contains Compound I having the following structural formula: a pharmaceutically acceptable polymer, and a pharmaceutically acceptable cationic species.

Abstract: The present invention provides efficient methods based on alteration of the protein A-binding ability, for producing or purifying multispecific antibodies having the activity of binding to two or more types of antigens to high purity through a protein A-based purification step alone. The methods of the present invention for producing or purifying multispecific antibodies which feature altering amino acid residues of antibody heavy chain constant region and/or variable region. Multispecific antibodies with an altered protein A-binding ability, which exhibit plasma retention comparable or longer than that of human IgG1, can be efficiently prepared in high purity by introducing amino acid alterations of the present invention into antibodies.

Abstract: The purpose of the present invention is to provide: a cancer stem cell mass from which cells incapable of forming cancer are substantially removed and which has a characteristic property of reproducing a layered structure of a cancer tissue; a process for producing the cancer stem cell mass; and use of the cancer stem cell mass. For achieving the purpose, the present inventors grew a human cancer tissue repeatedly in a NOG mouse, separated cancer cells from the grown cancer tissue, and made a comparison of various cancer cell culture processes with each other. As a result, a cancer stem cell composition which is homogeneous and is substantially free of the coexistence of cells capable of forming cancer and cells incapable of forming cancer in a mixed state can be produced successively by employing an attached culture process using a serum-free stem cell culture medium rather than a generally employed floating culture process, and consequently the present invention has been accomplished.

Abstract: A pharmaceutical composition for the treatment of interleukin-6 (IL-6) related diseases, comprising an interleukin-6 antagonist (IL-6 antagonist) and immunosuppressants. The IL-6 antagonist is preferably an antibody to an interleukin-6 receptor (IL-6R).

Abstract: It is intended to disclose an antibody which binds to DLL3 protein. Preferably, the antibody of the present invention recognizes a region from amino acids 216 to 492 in human DLL3 having the amino acid sequence as set forth in SEQ ID NO: 1. The present invention also provides a pharmaceutical composition, for example, an anticancer agent, comprising the antibody of the present invention as an active ingredient. The present invention further discloses a method for diagnosing cancer using the antibody of the present invention and a diagnostic drug for cancer comprising the antibody of the present invention.

Abstract: An objective of the present invention is to provide an Fc region variant with enhanced Fc?RIIb-binding activity, and/or enhanced binding selectivity to Fc?RIIb compared to Fc?RIIa (type R), as compared to those of a polypeptide containing an Fc region to which an amino acid alteration(s) has not been introduced; a polypeptide which includes the Fc region variant; a pharmaceutical composition containing the polypeptide; preventing therapeutic or preventive agent for immunological inflammatory diseases that includes the pharmaceutical composition; a production method thereof; and a method of enhancing Fc?RIIb-binding activity and also enhancing binding selectivity to Fc?RIIb compared to Fc?RIIa (type R).

Abstract: Provided is a method capable of producing a protein at a high level using a cultured animal cell, comprising culturing a cell that expresses APES (Antibody Production Enhancing Sequence) and into which a DNA encoding a desired polypeptide has been introduced, thereby producing the desired polypeptide. APES contains a nucleotide sequence related to nuclear factor ?B inhibitor ? (NfkBia) and has a function of decreasing the intracellular expression of NfkBia.

Abstract: Herein is reported a method for the production of an immunoglobulin comprising the following steps: a) providing a eukaryotic cell comprising a nucleic acid encoding the immunoglobulin, b) cultivating the eukaryotic cell in a cultivation medium wherein the amount of glucose available in the cultivation medium per time unit is kept constant and limited to less than 80% of the amount that could maximally be utilized by the cells in the cultivation medium per time unit, and c) recovering the immunoglobulin from the culture.

Abstract: An amorphous form of 9-ethyl-6,6-dimethyl-8-(4-morpholin-4-yl-piperidin-1-yl)-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile and a solid dispersion containing the amorphous form can be used extremely advantageously as drugs for oral administration.

Abstract: The inventors discovered that by administering a pharmaceutical composition comprising a bispecific antigen-binding molecule that recognizes blood coagulation factor IX and/or activated blood coagulation factor IX and blood coagulation factor X and/or activated blood coagulation factor X according to a given dosage regimen, diseases that develop and/or progress due to a decrease or deficiency in the activity of blood coagulation factor VIII and/or activated blood coagulation factor VIII can be prevented and/or treated more effectively.

Abstract: The present invention relates to a drug that is for treating or preventing cancer, that is effective in the treatment of cancer, and that comprises a combination of an ALK inhibitor and a VEGF inhibitor. The present invention also relates to a method for treating or preventing cancer and a method for inhibiting tumor growth.