Abstract: The present invention relates to anti-MASP-2 inhibitory antibodies and compositions comprising such antibodies for use in inhibiting the adverse effects of MASP-2 dependent complement activation.

Abstract: This disclosure is directed to mixed micelle compositions for administration of e.g., therapeutic agents or imaging agents to a subject.

Abstract: The present invention relates to an aqueous pharmaceutical composition suitable for long-term storage of polypeptides containing an Fc domain of an immunoglobulin, methods of manufacture, methods of administration and kits containing same.

Abstract: The present invention relates to an aqueous pharmaceutical composition suitable for long-term storage of polypeptides containing an Fc domain of an immunoglobulin, methods of manufacture, methods of administration and kits containing same.

Abstract: The present invention relates to an aqueous pharmaceutical composition suitable for long-term storage of polypeptides containing an Fc domain of an immunoglobulin, methods of manufacture, methods of administration and kits containing same.

Abstract: The present invention relates to an aqueous pharmaceutical composition suitable for long-term storage of polypeptides containing an Fc domain of an immunoglobulin, methods of manufacture, methods of administration and kits containing same.

Abstract: The present invention relates to an aqueous pharmaceutical composition suitable for long-term storage of polypeptides containing an Fc domain of an immunoglobulin, methods of manufacture, methods of administration and kits containing same.

Abstract: Small diameter particles of biologically active molecules are produced by atomizing solutions of the molecules through a nozzle into very cold liquified gases, which immediately freeze the atomized droplets. The resulting frozen particles having diameters of approximately 10 to 90 micrometers are lyophilized to produce porous particles, suspended in a non-solvent for the molecules, and exposed to ultrasonic energy or homogenization to produce particles having diameters of 0.1 to 10 micrometers with greater than 70 to 95% of the initial biological activity of the molecules in solution.

Abstract: Formulations for controlled, prolonged release of GM-CSF have been developed. These are based on solid microparticles formed of the combination of biodegradable, synthetic polymers such as poly(lactic acid) (PLA), poly(glycolic acid) (PGA), and copolymers thereof with excipients and drug loadings that yield zero order or first order release, or multiphasic release over a period of approximately three to twenty one days, preferably one week, when administered by injection. In the preferred embodiment, the microparticles are microspheres having diameters in the range of 10 to 60 microns, formed of a blend of PLGA having different molecular weights, most preferably 6,000, 30,000 and 41,000. Other embodiments have been developed to alter the release kinetics or the manner in which the drug is distributed in vivo.

Abstract: The invention pertains to a controlled release pharmaceutical formulation that has an effective amount of a polypeptide selected from the group consisting of: (a) TNFR, (b) IL-1R, (c) IL-1ra, (d) IL-6R and (e) a monoclonal antibody that is immunoreactive against TNF, IL-6 or IL-1; wherein the polypeptide is encapsulated in alginate. The invention also pertains to methods of treating inflammatory bowel disease by administering the above composition to a patient in need thereof.

Abstract: Compositions comprising an immunogenic amount of an antigen encapsulated in a stabilized hydrogel microbead are disclosed. The compositions provide a delivery system for antigens such as vaccines. Also provided are methods of stimulating an immune response comprising administration of the inventive compositions.

Abstract: Alginate beads are employed as a site specific oral delivery system for cationic therapeutic agents, such as TGF-.beta..sub.1, designed to target the agents to the luminal side of the small intestine. Improved delivery of bioactive material is obtained by: 1) incorporating selected polyanions in the alginate beads to shield the cationic therapeutic agent from interaction with alginate and/or 2) acid treating alginate beads containing the therapeutic agents to reduce the molecular weight of alginate and its interaction with the agents. Enhanced bioactivity of therapeutic agents released from the alginate is attributed to the ability of polyacrylic acid to shield the agents from interaction with lower molecular fragments of acid treated alginate.

Abstract: A process for preparing microspheres using very cold temperatures to freeze polymer-biologically active agent mixtures into polymeric microspheres with very high retention of biological activity and material. Polymer is dissolved in a solvent together with an active agent that can be either dissolved in the solvent or dispersed in the solvent in the form of microparticles. The polymer/active agent mixture is atomized into a vessel containing a liquid non-solvent, alone or frozen and overlayed with a liquified gas, at a temperature below the freezing point of the polymer/active agent solution. The cold liquified gas or liquid immediately freezes the polymer droplets. As the droplets and non-solvent for the polymer is warmed, the solvent in the droplets thaws and is extracted into the non-solvent, resulting in hardened microspheres.