Abstract: The present invention provides improved methods for the manufacturing of IVIG products. These methods offer various advantages such as reduced loss of IgG during purification and improved quality of final products. In other aspects, the present invention provides aqueous and pharmaceutical compositions suitable for intravenous, subcutaneous, and/or intramuscular administration. In yet other embodiments, the present invention provides methods of treating a disease or condition comprising administration of an IgG composition provided herein.

Abstract: Provided herein are compositions, including pharmaceutical compositions, and methods for modulating, i.e., stimulating or inhibiting, activity of the alternative complement pathway, and methods of identifying factor H-binding proteins.

Abstract: An adsorbent for immunosuppressive substance, which can adsorb an excessive immunosuppressive substance directly from a body fluid, can carry out extracorporeal perfusion safely and can be utilized in treatment of cancer. The excessive immunosuppressive substance may be involved in growth of cancer cells. The adsorbent for immunosuppressive substance includes a water-insoluble carrier and a hydrophilic amino group immobilized to the water-insoluble carrier. An extracorporeal perfusion column contains the adsorbent of the invention. A method for treating cancer carries out extracorporeal perfusion using the extracorporeal perfusion column. A method of adsorbing the transforming growth factor ? which is combined with another protein, includes adsorbing the transforming growth factor ? and protein on an adsorbent containing a water-insoluble carrier to which quaternary ammonium groups each having 3 to 18 carbon atoms per one nitrogen atom are attached, and having a specific surface area of 0.

Abstract: The invention relates to a novel, industrial-scale process for the purification of gamma-immunoglobulins (IgG) starting from plasma or fractions thereof. The method involves two chromatographic steps, i.e. a cation exchange capture chromatography, and then a polishing anion exchange chromatography, ensuring a highly purified end product, which contains no aggregates, and high yields. The process also involves a virus inactivation step by means of a solvent/detergent treatment to inactivate the viruses with a lipid envelope, and a virus removal step by nanofiltering to ensure the removal of the non-enveloped viruses.

Abstract: The present invention relates to a process for the preparation of polymer conjugates of indolocarbaxole compounds, in particular of polymer conjugates of K-252a and derivatives thereof, by a synthetic route which results in a highly pure product, with a high product yield. In a further aspect the present invention relates to novel polymer conjugates of K-252a and derivatives thereof, wherein the chemical group linking the polymer unity to the K-252a or to the K-252a derivative compound is characterized by a 5-member oxazolidindionic cyclic structure. These novel polymer conjugates are obtained through the novel synthetic route with high purity and high yields.

Abstract: The invention relates to a supramolecular polymer obtained from the reaction of (i) an amine bearing a nitrogen-containing heterocyclic group: imidazolidone, trimethyleneurea or triazine, which is capable of associating by means of hydrogen bonds and (ii) at least one fatty acid monomer comprising at least one reactive function, a dimer of identical or different fatty acids and/or a trimer of identical or different fatty acids, or a derivative of said fatty acid(s) which is selected from a fatty acid ester, and a fatty acid chloride.

Abstract: The present invention provides a chromatography packing material having improved flow rate characteristics and adsorption characteristics. In particular, the present invention provides a chromatography packing material suitable for separation and purification of immunoglobulin in the manufacture of antibody preparations. A porous cellulose gel, which is made by adding polysaccharides having a limiting viscosity of 0.21 to 0.90 dL/g to porous cellulose particles, the dry weight per unit volume of the porous cellulose gel being 1.06 to 1.40 times the dry weight per unit volume of the porous cellulose particles, is used. By adding a predetermined amount of polysaccharides having a predetermined limiting viscosity to porous cellulose particles, flow rate characteristics and adsorption characteristics can be improved.

Abstract: The present invention is directed to a novel biocompatible polymer that may be used in tissue engineering. More specifically, the specification describes methods and compositions for making and using a citric acid copolymers.

Abstract: Provided are a contrast agent for contrast imaging lymph node, which includes iron oxide nanoparticles dispersed and stabilized in an aqueous medium by a mussel adhesive protein-mimetic copolymer, a method for contrast enhanced lymphography using the foregoing contrast agent, and a method for diagnosis of lymph node cancers using the foregoing contrast agent. Using such a mussel adhesive protein-mimetic copolymer, the surface of iron oxide is modified and dispersed well in water to prepare a colloidal solution, which in turn forms the contrast agent containing the colloidal solution. The inventive contrast agent does not have toxicity and is easily taken up to the lymph node to exhibit excellent contrast imaging effects. The contrast agent of the present invention is useful for diagnosis of metastatic cancers.

Abstract: Amide compounds, amide polymers, compositions including amide compounds and amide polymers may be used to bind target ions, such as phosphorous-containing compounds in the gastrointestinal tract of animals. In some cases, amide compounds and amide polymers may include a core derived from an amide polyol and an organic polyacid or ester.

Abstract: The present invention provides semi-fluorinated block copolymers and related methods of synthesizing and using semi-fluorinated block copolymers for drug delivery and drug formulation applications. Semi-fluorinated block copolymers of this aspect of the invention include block copolymers having discrete hydrophilic, fluorophilic and hydrophobic structural domains that are capable of forming supramolecular structures in aqueous solutions, such as micelles, for encapsulating hydrophobic and/or fluorophilic therapeutic agents. Encapsulation by semi-fluorinated block copolymers of the present invention allows for enhanced solubilization and stabilization of hydrophobic and/or fluorophilic therapeutic agents relative to conventional drug delivery compositions and methods.

Abstract: Proteins, including monoclonal antibodies, that have been retained on hydroxyapatite resins for purposes of protein separation, purification, or both, are eluted from the resins by a elution buffer that contains controlled amounts of calcium and phosphate ions. The buffer allows elution to be performed in repeated runs at an acidic pH without deterioration of the resin.

Abstract: The composition for stimulating an immune response in a subject comprises methyl vinyl ether and maleic anhydride copolymer-based nanoparticles. Said nanoparticles may further contain an allergen or an antigen and/or an immunostimulating agent, which may be contained inside said nanoparticles and/or at least partially coating the surface of said nanoparticles, and optionally a cross-linking agent. The immune response stimulating composition is useful as an adjuvant in immunotherapy and vaccines.

Abstract: It is disclosed here a method for reducing phosphate absorption in a human or non-human animal subject wherein the subject consumes a diet containing phytic acid or phytate and either has or is at risk of developing hyperphosphatemia. The method includes the step of administering orally to the subject an anti-intestinal alkaline phosphatase antibody in an amount effective to reduce or maintain the serum phosphate concentration in the subject.

Abstract: Systems, compositions, methods, and kits for identifying potential therapeutic agents for treatment of complement based ocular diseases are provided herein. The methods and kits include a complement component 3 (C3) protein or derivative that is contacted to ocular cells or tissue. Another embodiment of the invention herein provides for diagnosis and/or prognosis of a complement-associated ocular disease. Compositions, methods and kits for regulating or treating a complement-related condition using at least one of CD46 protein, CD55 protein, and a recombinant chimeric soluble terminator of activated complement (STAC) protein or source of the STAC protein. The STAC protein includes an amino acid sequence including at least two of an amino acid sequence of a CD59 protein, an amino acid sequence derived from a CD46 protein, and an amino acid sequence derived from a CD55 protein, optionally further comprising a linker to connect amino acid sequences.

Abstract: Methods, kits and apparatuses for chromatography purification of antibodies are provided. In some embodiments, antibodies are purified by mixed mode chromatography that does not comprise hydroxyapatite (HT) or fluorapatite (FT). The mixed mode chromatography step is then followed by a HT/FT chromatography step.

Abstract: The present invention relates to pH-sensitive mucoadhesive film-forming gels and wax-film composites suitable for topical and mucosal delivery of molecules of interest, namely active pharmaceuticals. The gels comprise a pharmaceutically acceptable pH-sensitive polymer that responds to a lowering of pH by precipitating into films when in contact with the skin or mucosal surface. The films also comprise an adhesive polymer that allows the film to remain in contact with the tissue for an extended period of time. The wax-film composites comprise a bi-layer film having both the said pH-sensitive mucoadhesive layer to promote strong adherence to the skin and mucosal surfaces as well as a specially bonded wax layer intended to extend the adherence of the film to tissues for a prolonged period of time.

Abstract: Polymeric reagents comprising a polymer attached, either directly or through one or more atoms, to a ketone or a related functional group such as ketone hydrate, thione, monothiohydrate, dithiohydrate, hemiketal, monothiohemiketal, dithiohemiketal, ketal, or dithioketal are provided. The polymeric reagents are useful for, among other things, forming polymer-active agent conjugates. Related methods, compositions, preparations, and so forth are also provided.

Abstract: The present invention relates to methods for harvesting of antibodies from an antibody library. The antibodies are harvested by utilizing a certain epitope that is analogous to the epitope of the antigen used for immunization but that may differ in global physical and biochemical properties allowing the production of antibodies against antigens that normally can not be utilized as immunizing agents. The present invention furthermore relate to fields of use for harvested antigens in industry, agriculture and healthcare.

Abstract: An injectable depot formulation includes a biocompatible polymer, an organic solvent combined with the biocompatible polymer to form a viscous gel, and a small molecule drug incorporated in the viscous gel such that the formulation exhibits an in vivo release profile having Cmax to Cmin ratio less than 200 and lag time less than 0.2.