The present invention relates to particularly stable and soluble scFv antibodies and Fab fragments specific for TNF, which comprise specific light chain and heavy chain sequences that are optimized for stability, solubility, in vitro and in vivo binding of TNF, and low immunogenicity. The antibodies are designed for the diagnosis and/or treatment of TNF-mediated disorders. The nucleic acids, vectors and host cells for expression of the recombinant antibodies of the invention, methods for isolating them and the use of the antibodies in medicine are also described.

It is an object of the present invention to provide a method for efficiently producing a B cell population comprising B cells that recognize a specific antigen. According to the present invention, provided is a method for producing a B cell population, comprising: a step (c) of culturing a cell population comprising B cells together with a specific antigen in the absence of IL-21, in the absence of IL-4, and in the presence of a cytokine other than IL-21 and IL-4, while giving stimulation mediated by CD40 and a BAFF receptor to the cells; and a step (d) of culturing the cell population comprising B cells, while giving stimulation mediated by has to the cells, so as to obtain a B cell population comprising B cells that recognize the specific antigen.

The present invention is directed to methods for filling a container wherein the filled container has no headspace. The present invention is further directed to methods for stabilizing an aqueous drug substance solution by filling a container with the aqueous drug substance solution wherein the filled container has no headspace. The present invention is further directed to methods for detecting headspace in a container.

Systems and methods to genetically modify B cells to express selected antibodies are described. The systems and methods can be used to: obviate the need for classical vaccinations; provide protection against infectious agents for which no vaccinations are currently available; provide protection against infectious agents when patients are otherwise immune-suppressed; and/or provide a benefit provided by a therapeutic antibody, such as in the treatment of autoimmune disorders.

It is an object of the present invention to provide a human monoclonal antibody that has a high inhibitory activity on phosphorylation of Ser46 of human MARCKS and binds specifically to human HMGB1, and a pharmaceutical composition or the like for treating or preventing Alzheimer's disease, containing the antibody as an active component. A human monoclonal antibody that binds specifically to human HMGB1 and contains a heavy-chain CDR1, a heavy-chain CDR2, and a heavy-chain CDR3 consisting of specific amino acid sequences and a light-chain CDR1, a light-chain CDR2, and a light-chain CDR3 consisting of specific amino acid sequences is used. The human monoclonal antibody can also be used as a pharmaceutical composition for treating or preventing Alzheimer's disease.

It is an object of the present invention to provide a human monoclonal antibody that has a high inhibitory activity on phosphorylation of Ser46 of human MARCKS and binds specifically to human HMGB1, and a pharmaceutical composition or the like for treating or preventing Alzheimer's disease, containing the antibody as an active component. A human monoclonal antibody that binds specifically to human HMGB1 and contains a heavy-chain CDR1, a heavy-chain CDR2, and a heavy-chain CDR3 consisting of specific amino acid sequences and a light-chain CDR1, a light-chain CDR2, and a light-chain CDR3 consisting of specific amino acid sequences is used. The human monoclonal antibody can also be used as a pharmaceutical composition for treating or preventing Alzheimer's disease.

The present invention concerns the combination of CTLA4 and IL-17B inhibitors, especially for the treatment of patients and diseases resistant to anti-CTLA4 therapies.

Provided is a liquid preparation containing an anti-IL-17 antibody at a concentration of 20 mg/mL to 200 mg/mL, a citrate buffer at a concentration of 10 mM to 50 mM, a sucrose at a concentration of 20 mg/mL to 120 mg/mL or arginine at a concentration of 50 mM to 250 mM, and polysorbate 80 at a concentration of 0.1 mg/mL to 5 mg/mL. In addition, the liquid preparation has a pH of 6.0±0.5, wherein the anti-IL-17 antibody is an anti-IL-17A/F monoclonal antibody. The liquid preparation can be a stable subcutaneous injection preparation, and can be used to treat IL-17A and/or IL-17F related diseases, such as psoriasis, psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, osteoarthritis or inflammatory bowel disease.

The present disclosure relates to methods of manufacture for producing anti-IL-12/IL-23p40 antibodies, e.g., the anti-IL-12/IL-23p40 antibody ustekinumab, and specific pharmaceutical compositions of the antibody.

The present invention relates to methods of manufacture for producing a drug substance (DS) or drug product (DP) comprising a mammalian anti-TNF antibody having a heavy chain (HC) comprising SEQ ID NO: 36 and a light chain (LC) comprising SEQ ID NO: 37.