Abstract: The invention relates to nanoparticles comprising a biodegradable polymer, a cyclodextrin or a derivative thereof, and a biologically active molecule. Said nanoparticles can associate large amounts of biologically active molecules, especially of a hydrophobic nature, and release the biologically active molecule providing sustained and constant plasma levels thereof when they are administered orally or through any other mucosa of the organism.

Abstract: Processes for producing and purifying recombinant proteins are disclosed. In particular, the present disclosure provides processes of producing and purifying multi-subunit proteins expressed in yeast or filamentous fungal cells. The production and/or purification of such proteins are monitored for impurities, preferably using lectin binding assays, such that one or more process parameters may be adjusted to maximize the amount of desired recombinant protein and minimize the amount of glycosylated impurities. The processes can also be monitored for other undesired product-associated impurities, such as aggregates and nucleic acids. In exemplary embodiments, the recombinant proteins are multi-subunit proteins, such as antibodies, the host cell is a yeast, such as Pichia pastoris, and the glycosylated impurity is a glycovariant of the desired recombinant polypeptide, such as an N-linked and/or O-linked glycovariant.

Abstract: Novel classes of multi-arm polyalkylene oxide-based materials including PEG nanocarriers, nanogel particles, and aggregated nanogel particles are disclosed. These classes of compositions may be associated with therapeutic agents and targeting moieties, or visibility enhancing agents, and may have a modified surface structure. In some embodiments the PEG-based materials can be made to provide relatively high drug loads with improved solubility and targeted delivery.

Abstract: The present invention relates to compositions and methods for treating sialic acid deficiencies comprising extended release formulations.

Abstract: The invention provides a washing method for affinity chromatography in which a wash solution comprising arginine, or an arginine derivative, and a nonbuffering salt, preferably at high pH, greater than 8.0, is effective in removing impurities, such as high molecular weight species and host cell proteins, while also increasing product concentration in the eluate and maintaining a high percent yield of recovered product.

Abstract: Suggested is a process for obtaining immunoglobulins, wherein (a) colostral milk from days 0 to 7 is subjected to thermal treatment, skimming the cream, (b) the skimmed milk such obtained is subjected to sterile microfiltration thus producing a first retentate R1 which contains the casein, and a first permeate P1, (c) the first permeate P1 is subjected to ultrafiltration thus producing a second permeate P2 which contains lactose and minerals, and a second retentate R2, in which the immunoglobulins are concentrated.

Abstract: The present invention relates to a method for producing a domain antibody in a yeast, wherein the formation of disulfide bridges in the domain antibody is promoted. The method encompasses the addition of oxidizing agents, preferably oxidizing metal ions, preferably one or more selected from Cu2+, Fe2+, Fe3+ and Zn2+.

Abstract: A risperidone sustained release microsphere formulation is provided. The microsphere formulation comprise risperidone or 9-hydroxy risperidone or salts thereof, and a polymer blend having a first uncapped lactide-glycolide copolymer and a second uncapped lactide-glycolide copolymer, in which the first uncapped lactide-glycolide copolymer is a copolymer with a high intrinsic viscosity and the second uncapped lactide-glycolide copolymer is a copolymer with a low intrinsic viscosity. The sustained release micro sphere formulation according to an embodiment of the present disclosure is suitable for large-scale industrialized production with improved stability, the in vivo release behavior of which will not change after long-term storage.

Abstract: The present disclosure relates to, inter alia, compositions containing an inhibitor of human complement and use of the compositions in methods for treating or preventing complement-associated disorders. In some embodiments, the inhibitor is chronically administered to patients. In some embodiments, the inhibitor is administered to a patient in an amount and with a frequency to maintain systemic complement inhibition and prevent breakthrough. In some embodiments, the compositions contain an antibody, or antigen-binding fragment thereof, that binds to a human complement component C5 protein or a fragment of the protein such as C5a or C5b.

Abstract: A process for purification of a fragment antibody from a culture medium also comprising at least one impurity is provided. The purification is carried out after the pH of the culture medium has been reduced to a pH at which the fragment antibody is soluble, but one or more of the impurities are insoluble. A process for the preparation of a fragment antibody employing such a purification process is also provided.

Abstract: Diagnostic tests for characterizing an individual's risk of developing or having a cardiovascular disease. In one embodiment the present diagnostic test comprises determining the level of myeloperoxidase (MPO) activity in a bodily sample obtained from the individual or test subject. In another embodiment, the diagnostic test comprises determining the level of MPO mass in a bodily sample obtained from the test subject. In another embodiment, the diagnostic test comprises determining the level of one or more select MPO-generated oxidation products in a bodily sample obtained from the test subject. The select MPO-generated oxidation products are dityrosine, nitrotyrosine, methionine sulphoxide or an MPO-generated lipid peroxidation products.

Abstract: The present invention relates to an adhesive hydrogel composition containing catechol group-coupled chitosan and Pluronic comprising a thiol group coupled to the end thereof, and more specifically, to an adhesive composition which is safe in vivo and in vitro, is temperature sensitive, and has an excellent hemostatic effect and thus can be used as a bioadhesive, and a medical adhesive, an adhesion barrier and a surface adsorption inhibitor comprising the same.

Abstract: A solution having improved mold and mildew stain removing properties on hard surfaces, that is easier to handle (less corrosive and less malodorous) and that is environmentally friendly. The mold and mildew stain removing solution includes the following components: a surfactant selected from the group consisting of alcohol ethoxylates, alkyl sulfates, alkyl ether sulfates, alpha olefin sulfonates, alkyl phosphates, alkyl amidopropyl betaines, alkyl betaines, amphoacetates, amphoproprionates, amphosulfonates, amine oxides, alkanolamides, sulfosuccinates, and sultaines, a solvent, and at least one chelating agent. The solution may further comprise a hydrotrope, a diluent, a preservative, and/or a fungicide. The surfactant is preferably an alcohol ethoxylate. The hydrotrope is preferably lauramine oxide. The solvent is preferably a glycol ether. The chelating agents are preferably sodium gluconate and a solution of the trisodium salt of methyl glycine diacetic acid.

Abstract: The present disclosure provides methods for purifying products from a fluid. In some embodiments, provided purification methods use a combination of purification modes (e.g., protein A and ion exchange) operated in tandem, wherein at least one of the modes utilizes weak partitioning. In some embodiments, provided purification methods operate under robust conditions in which a degree of binding between a product and resin is maintained despite variations in operating parameters.

Abstract: The present invention provides methods for purifying a polypeptide comprising a CH2/CH3 region, comprising binding the polypeptide to Protein A and eluting with a pH gradient starting at a low pH.

Abstract: Herein is reported a method for the purification of an antibody directly captured from clarified cell culture supernatants using Streamline CST and/or Capto MMC, wherein especially product related (aggregates and fragments) and process related impurities (host cell protein, media components) could efficiently be removed, resulting in a preparation with a purity comparable to classical protein A affinity chromatography.

Abstract: The present invention provides various fluorescent conjugated polymers with a BODIPY-based backbone. The invention also provides methods of using the polymers of the invention, such as for imaging and detection of cells, tumors, bacteria and viruses.

Abstract: Coatings for an implantable medical device and a method of fabricating thereof are disclosed, the coatings comprising polymers of lactic acid.

Abstract: One aspect of the present invention generally relates to methods of sealing a wound or tissue plane or filling a void splace. In a preferred embodiment, the wound is an ophthalmic, pleural or dural wound. In certain instances, the compositions used to seal the wound or tissue plane comprises a polyalkyleneimine. In a preferred embodiment, the polyalkyleneimine is polyethyleneimine. Treatment of the polyethyleneimine with a cross-linking reagent causes the polyethyleneimine polymers to polymerize forming a seal. In certain instances, the cross-linking reagent is a polyethylene glycol having reactive terminal groups. In certain instances, the reactive terminal groups are activated esters, such as N-hydroxy succinimide ester. In certain instances, the reactive terminal groups are isocyanates. In certain instances, the polyethyleneimine has a lysine, cysteine, isocysteine or other nucleophilic group attached to the periphery of the polymer.

Abstract: Herein is reported a method for producing a polypeptide in monomeric form comprising the following step: recovering the polypeptide in monomeric form from an ion exchange chromatography material by applying a solution comprising a non-ionic polymer and an additive.