Patent classifications
A61K39/39591
PROGRAMMED CELL DEATH RECEPTOR 1 ANTIBODY FORMULATION AND USE THEREOF
The present invention provides a pharmaceutical formulation containing an anti-PD-1 monoclonal antibody. The pharmaceutical formulation comprises an anti-PD-1 monoclonal antibody, a citrate-sodium citrate buffer solution, a protein protectant, a surfactant, and an isotonic regulator. The present invention also relates to an application of the pharmaceutical formulation in the preparation of a liquid formulation or lyophilized formulation for injection.
Pharmaceutical formulations
The invention relates to a liquid pharmaceutical formulation comprising an antibody or antigen-binding fragment thereof, cyclodextrin and methionine. In addition, it relates to a method for reducing precipitation of an antibody or an antigen-binding fragment thereof in a liquid pharmaceutical formulation through addition of methionine and cyclodextrin. In particular, the liquid pharmaceutical formulations comprises an anti-sclerostin antibody, hydroxypropyl-gamma cyclodextrin and methionine and may be used in the treatment of a bone disorder associated with at least one of low bone formation, low bone mineral density, low bone mineral content, low bone mass, low bone quality and low bone strength, and especially for treating osteoporosis. Furthermore, the invention relates to a method of reducing inflammation at injection site in a mammalian subject comprising administering a therapeutically effective amount of a liquid pharmaceutical formulation comprising an antibody or antigen-binding fragment thereof, cyclodextrin and methionine.
Method of filling a container with no headspace
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.
LIQUID PREPARATION CONTAINING ANTI-IL-17 ANTIBODY
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.
ANTI-PD-L1 ANTIBODY FORMULATIONS
The invention provides liquid pharmaceutical formulations comprising an anti-PD-L1 antibody, such as liquid pharmaceutical formulations for subcutaneous administration. The invention also provides methods for making such formulations and methods of using such formulations.
PROTEIN FORMULATIONS AND METHODS OF MAKING SAME
The invention provides an aqueous formulation comprising water and a protein, and methods of making the same. The aqueous formulation of the invention may be a high protein formulation and/or may have low levels of conductity resulting from the low levels of ionic excipients. Also included in the invention are formulations comprising water and proteins having low osmolality.
Glycan-interacting compounds and methods of use
The present invention provides glycan-interacting antibodies and methods for producing glycan-interacting antibodies useful in the treatment and prevention of human disease, including cancer. Such glycan-interacting antibodies include monoclonal antibodies, derivatives, and fragments thereof as well as compositions and kits comprising them. Further provided are methods of using glycan-interacting antibodies to target cells and treat disease.
Pharmaceutical formulations of FcRn inhibitors suitable for subcutaneous administration
Provided are various aqueous formulations of the neonatal Fc receptor (FcRn) antagonist ARGX-113, including formulations useful as pharmaceutical compositions, methods for their preparation, devices comprising the various formulations, and uses thereof. In certain embodiments the formulations are suitable and useful for administration of ARGX-113 to a human subject. In certain embodiments the formulations are suitable and useful for subcutaneous administration of ARGX-113 to a human subject. The formulations can be used in the treatment of any condition that would benefit from inhibition of FcRn-mediated antibody recycling. Such conditions can include any one or more of various antibody-mediated autoimmune diseases, including, for example and without limitation, myasthenia gravis (MG) and immune thrombocytopenia (ITP).
Stable Antibody Containing Compositions
The invention relates to stable and low viscous (<50 cP) protein containing compositions, in particular, but not exclusively stable antibody containing compositions and to the use of said stable proteins in therapy, in particular for the subcutaneous delivery of said stable protein.
Stabilized Formulations Containing Anti-Interleukin-4 Receptor (IL-4R) Antibodies
The present invention provides pharmaceutical formulations comprising a human antibody that specifically binds to human interleukin-4 receptor (hIL-4R). The formulations may contain, in addition to an anti-hIL-4R antibody, at least one amino acid, at least one sugar, or at least one non-ionic surfactant. The pharmaceutical formulations of the present invention exhibit a substantial degree of antibody stability after storage for several months.