Abstract: An automatic injection device for providing a subcutaneous injection is disclosed. The device includes a syringe movably disposed in a housing and including a barrel portion, a needle and a bung for sealing the barrel portion. The device includes a plunger for moving the syringe towards a first open end of the housing such that the needle projects from the first end, and for subsequently applying pressure to the bung. The plunger includes a rod connected at a first end to the bung, a compressible expanded central portion, and a flange between a second end of the rod and the central portion. The device also includes a biasing mechanism for biasing the plunger towards the first open end of the housing, the biasing mechanism disposed about the second end of the rod between the flange and a second end of the housing.

Abstract: A liquid aqueous pharmaceutical formulation is described which has a high protein concentration, a pH of between about 4 and about 8, and enhanced stability.

Abstract: Methods of treating disorders in which TNF? activity is detrimental via biweekly, subcutaneous administration of human antibodies, preferably recombinant human antibodies, that specifically bind to human tumor necrosis factor ? (hTNF?) are disclosed. The antibody may be administered with or without methotrexate. These antibodies have high affinity for hTNF? (e.g., Kd=10?8 M or less), a slow off rate for hTNF? dissociation (e.g., Koff=10?3 sec?1 or less) and neutralize hTNF? activity in vitro and in vivo. An antibody of the invention can be a full-length antibody or an antigen-binding portion thereof. Kits containing a pharmaceutical composition and instructions for dosing, and preloaded syringes containing pharmaceutical compositions are also encompassed by the invention.

Abstract: A liquid aqueous pharmaceutical formulation is described which has a high protein concentration, a pH of between about 4 and about 8, and enhanced stability.

Abstract: Exemplary embodiments provide a syringe plunger formed of a polymeric material. The syringe plunger includes a pressurizer disposed at a proximal end, and a distal end bifurcated into a first plunger arm having a first conical surface and a second conical surface, and a second plunger arm having a first conical surface and a second conical surface. The distal end includes a first contact surface defined by the first conical surface of the first plunger arm and the first conical surface of the second plunger arm, the first contact surface configured to initially contact a firing engagement mechanism, the first contact surface disposed at a first angle of between about 40° and about 80° relative to a longitudinal axis of the syringe plunger.

Abstract: The invention provides methods, uses and compositions for the treatment of ankylosing spondylitis (AS). The invention describes methods and uses for treating ankylosing spondylitis, wherein a TNF? inhibitor, such as a human TNF? antibody, or antigen-binding portion thereof, is used to reduce signs and symptoms of ankylosing spondylitis in a subject. Also described are methods for determining the efficacy of a TNF? inhibitor for treatment of ankylosing spondylitis in a subject.

Abstract: A liquid aqueous pharmaceutical formulation is described which has a high protein concentration, a pH of between about 4 and about 8, and enhanced stability.

Abstract: A liquid aqueous pharmaceutical formulation is described which has a high protein concentration, a pH of between about 4 and about 8, and enhanced stability.

Abstract: The invention provides a method for producing a host cell protein-(HCP) reduced antibody preparation from a mixture comprising an antibody and at least one HCP, comprising an ion exchange separation step wherein the mixture is subjected to a first ion exchange material, such that the HCP-reduced antibody preparation is obtained.

Abstract: Methods of treating disorders in which TNF? activity is detrimental via biweekly, subcutaneous administration of human antibodies, preferably recombinant human antibodies, that specifically bind to human tumor necrosis factor ? (hTNF?) are disclosed. The antibody may be administered with or without methotrexate. These antibodies have high affinity for hTNF? (e.g., Kd=10?8 M or less), a slow off rate for hTNF? dissociation (e.g., Koff=10?3 sec?1 or less) and neutralize hTNF? activity in vitro and in vivo. An antibody of the invention can be a full-length antibody or an antigen-binding portion thereof. Kits containing a pharmaceutical composition and instructions for dosing, and preloaded syringes containing pharmaceutical compositions are also encompassed by the invention.

Abstract: A liquid aqueous pharmaceutical formulation is described which has a high protein concentration, a pH of between about 4 and about 8, and enhanced stability.

Abstract: The invention describes methods of treating erosive polyarthritis comprising administering a TNF? antibody, or antigen-binding portion thereof. The invention also describes a method for testing the efficacy of a TNF? antibody, or antigen-binding portion thereof, for the treatment of erosive polyarthritis.

Abstract: The invention provides a method for producing a host cell protein-(HCP) reduced antibody preparation from a mixture comprising an antibody and at least one HCP, comprising an ion exchange separation step wherein the mixture is subjected to a first ion exchange material, such that the HCP-reduced antibody preparation is obtained.

Abstract: The invention provides a method for producing a host cell protein-(HCP) reduced antibody preparation from a mixture comprising an antibody and at least one HCP, comprising an ion exchange separation step wherein the mixture is subjected to a first ion exchange material, such that the HCP-reduced antibody preparation is obtained.

Abstract: Multiple-variable dose methods for treating TNF?-related disorders, including Crohn's disease and psoriasis, comprising administering TNF? inhibitors, including TNF? antibodies, are described. Multiple-variable dose methods include administration of a TNF-inhibitor in an induction or loading phase followed by administration of the agent in a maintenance or treatment phase, wherein the TNF-inhibitor is administered in a higher dosage during the induction phase.

Abstract: Methods of treating disorders in which TFN? activity is detrimental via biweekly, subcutaneous administration of human antibodies, preferably recombinant human antibodies, that specifically bind to human tumor necrosis factor ? (hTNF?) are disclosed. The antibody may be administered with or without methotrexate. These antibodies have high affinity for hTNF? (e.g., Kd=10?8 M or less), a slow off rate for hTNF? dissociation (e.g., Koff=10?3 sec?1 or less) and neutralize hTNF? activity in vitro and in vivo. An antibody of the invention can be a full-length antibody or an antigen-binding portion thereof. Kits containing a pharmaceutical composition and instructions for dosing, and preloaded syringes containing pharmaceutical compositions are also encompassed by the invention.

Abstract: The invention provides a method for producing a host cell protein-(HCP) reduced antibody preparation from a mixture comprising an antibody and at least one HCP, comprising an ion exchange separation step wherein the mixture is subjected to a first ion exchange material, such that the HCP-reduced antibody preparation is obtained.

Abstract: The invention describes methods of treating depression comprising administering a TNF? antibody, such as a human TNF? antibody.

Abstract: A method of treating TNF? disorders is described, wherein the method comprises administering a low dose amount of a TNF? inhibitor.

Abstract: Exemplary embodiments provide a needle shield remover that reliably engages with a distal cap of an automatic injection device and with one or more needle shields coupled to a syringe of the device. When a user removes the distal cap, the needle shield remover reliably removes the needle shields (e.g., a soft needle shield and a rigid needle shield) from the syringe, thereby exposing the injection needle for performing an injection. In an exemplary assembly method, a needle shield remover is engaged to a needle shield coupled to a syringe, prior to insertion of the syringe and needle shield remover assembly into a housing of the device. This exemplary assembly method allows visual inspection, outside the housing of the device, to ensure that the needle shield remover is correctly and reliably engaged to the needle shield before the syringe and needle shield remover assembly is inserted into the housing.