Abstract: The present invention relates to a method for the measurement of active alpha1-proteinase inhibitor (A1PI) in a sample, comprising the steps of binding elastase to a solid support, letting the A1PI contained in the sample bind to the solid phase-bound elastase, and detecting solid phase-bound A1PI with a detection reagent.

Abstract: The present invention relates to a method for the selective determination of the concentration of an active human protease coagulation factor in a sample, comprising the steps of binding a specific inhibitor of the human protease coagulation factor to a solid phase, letting the human protease coagulation factor contained in the sample bind to the solid phase-bound inhibitor, and detecting the human protease coagulation factor bound to the solid phase-bound inhibitor with a detection reagent.

Abstract: The present invention relates to a method for the determination of polysorbate in a protein-containing sample. The method of the present invention involves the pretreatment of the sample by alkaline hydrolysis followed by colorimetric determination.

Abstract: The present invention relates to a method for determining the amount of a physiologically acceptable polymer molecule bound to a protein, an antibody or other composition being capable of specifically binding to a physiologically acceptable polymer molecule, and a kit containing said antibody or composition.

Abstract: Disclosed herein are methods, systems and kits to measure the presence and/or activity of recombinant polypeptides comprising a modification.

Abstract: The present disclosure relates to materials and methods of conjugating a water soluble polymer to a therapeutic protein.

Abstract: The present invention relates to a method for the measurement of active alpha1-proteinase inhibitor (A1PI) in a sample, comprising the steps of binding elastase to a solid support, letting the A1PI contained in the sample bind to the solid phase-bound elastase, and detecting solid phase-bound A1PI with a detection reagent.

Abstract: The present invention relates to a method for the determination of polysorbate in a protein-containing sample. The method of the present invention involves the pretreatment of the sample by alkaline hydrolysis followed by colorimetric determination.

Abstract: The present invention relates, in general, to methods for detecting and quantitating plasma-derived protein and recombinant protein in a sample based on the difference in protein glycosylation, when the plasma protein and the recombinant protein are essentially the same protein.

Abstract: The present invention relates, in general, to methods for detecting and quantitating plasma-derived protein and recombinant protein in a sample based on the difference in protein glycosylation, when the plasma protein and the recombinant protein are essentially the same protein.

Abstract: The present invention provides novel methods for reducing the serine protease and/or serine protease zymogen content of a plasma-derived protein composition. Also provided are methods for manufacturing plasma-derived protein compositions having reduced serine protease and\or serine protease zymogen content. Among yet other aspects, the present invention provides aqueous and lyophilized compositions of plasma-derived proteins having reduced serine protease and/or serine protease zymogen content. Yet other aspects include methods for treating, managing, and/or preventing a disease comprising the administration of a plasma-derived protein composition having a reduced serine protease or serine protease zymogen content.

Abstract: Provided herein are stable co-formulations of immunoglobulin and hyaluronidase that are stable to storage in liquid form at room temperature for at least 6 months and at standard refrigerator temperatures for 1-2 years. Such co-formulations can be used in methods of treating IG-treatable diseases or conditions by subcutaneous administration.

Abstract: The present invention relates, in general, to methods for detecting the amount of a polymer on a protein using near-infrared spectroscopy. Measurement of the number of polymer moieties per protein molecule allows for production of molecules having a uniform number of polymer moieties, which is useful in the production of pharmaceutical compositions.

Abstract: The invention relates to the development of in vitro assay systems that force the release of a water-soluble polymer, such as polyethylene glycol (PEG) and polysialic acid (PSA), from proteins modified with a reversibly-linked water-soluble polymer. The invention includes methods for analyzing the release of the water-soluble polymer and measuring regained protein activity. The invention further includes methods appropriate for the quality control of proteins modified with releasable water-soluble polymers, including polymers like PEG and PSA.

Abstract: The present invention relates, in general, to methods for detecting and quantitating plasma-derived protein and recombinant protein in a sample based on the difference in protein glycosylation, when the plasma protein and the recombinant protein are essentially the same protein.

Abstract: The present invention relates to a method for determining the amount of a physiologically acceptable polymer molecule bound to a protein, an antibody or other composition being capable of specifically binding to a physiologically acceptable polymer molecule, and a kit containing said antibody or composition.

Abstract: A method for the cryogenic separation of air having defined temperatures for condensed feed air passed into a double column system relative to liquid oxygen and preferably to shelf vapor, and wherein kettle liquid is not subcooled from the higher pressure column to the lower pressure column.

Abstract: The present invention provides methods of preparing alpha-1-antiproteinase inhibitor and controlling the amount of des-lys alpha-1-antiproteinase inhibitor in the preparation, and compositions comprising the same, as well as methods of treatment using the same.

Abstract: A cryogenic rectification system employing a phase separator, which may include one or more trays, in conjunction with a double column air separation plant, wherein some shelf liquid is subcooled and phase separated to produce crude neon vapor, and the remaining liquid is used to reflux the lower pressure column of the double column plant.

Abstract: A process for the production of ergosterol and its intermediate products using recombinant yeasts and plasmids for transformation of yeasts is described.