Abstract: In general, the systems and methods described in this application relate to laser-induced nucleation in continuous flow. A method of laser-induced nucleation in continuous flow includes injecting a saturated solution, undersaturated solution, or supersaturated solution through an inlet of a device. The method can include converting the saturated solution or undersaturated solution into supersaturated solution by changing a temperature of the saturated solution or undersaturated solution. The method can include passing one or more laser pulses through the supersaturated solution within the device. The method can include flowing the saturated solution, undersaturated solution, or the supersaturated solution through an outlet of the device.

Abstract: The present invention provides an improved method for preparing, purifying, precipitating, etc., a subject compound for use in a subsequent reaction carried out in suspension. The present invention relies on a precipitating solvent being added to an aqueous solution comprising the subject compound to form a precipitate of the subject compound, which may be further dried and/or purified. Compositions made according to present methods have improved characteristics and properties, such as increased surface and/or reduced density, resulting in a higher reactivity in a subsequent reaction carried out in suspension.

Abstract: A polypeptide solution of the present invention is a polypeptide solution in which a polypeptide derived from natural spider silk proteins is dissolved in a solvent. The solvent contains at least one selected from the following (i)-(iii): (i) DMSO; (ii) DMSO with an inorganic salt; and (iii) DMF with an inorganic salt. Further, in the present invention, an artificial polypeptide fiber is obtained by: using the polypeptide solution as a dope solution; and extruding the dope solution from a spinneret into a desolvation bath so as to eliminate the solvent from the dope solution and form a fiber to produce an undrawn yarn. Moreover, in the present invention, a polypeptide is purified by subjecting the polypeptide solution to heat treatment and thereafter removing an undissolved substance therefrom.

Abstract: A process for producing a protein product for addition to raw meat wherein the source of the protein product is animal muscle or mechanically deboned meat. The animal muscle tissue is mixed with water and homogenized. Protein in the homogenate is solubilized. Solubilized homogenate is heated to a temperature required for pasteurization and/or sterilization according to known standards. The homogenate is then adjusted to a value at which the protein precipitates. The precipitate is free of bacteria and toxins and can be used as meat or added to raw meat for delivery to a consumer as uncooked meat.

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: A polypeptide solution of the present invention is a polypeptide solution in which a polypeptide derived from natural spider silk proteins is dissolved in a solvent. The solvent contains at least one selected from the following (i)-(iii): (i) DMSO; (ii) DMSO with an inorganic salt; and (iii) DMF with an inorganic salt. Further, in the present invention, an artificial polypeptide fiber is obtained by: using the polypeptide solution as a dope solution; and extruding the dope solution from a spinneret into a desolvation bath so as to eliminate the solvent from the dope solution and form a fiber to produce an undrawn yarn. Moreover, in the present invention, a polypeptide is purified by subjecting the polypeptide solution to heat treatment and thereafter removing an undissolved substance therefrom.

Abstract: The present invention provides a method for producing a target protein in the form of a fusion protein at a high recovery ratio. The present invention relates to a method for producing a fusion protein made of a protein having a self-assembly capability and a target protein comprising the following steps (1) to (4): (1) preparing a solution containing the fusion protein; (2) adjusting a pH of the solution obtained in step (1) to such a pH that a recovery ratio calculated according to the following equation is 10% or more, where the recovery ratio (%)=[an amount of the fusion protein in a solution obtained in step (4)/{the amount of the fusion protein in the solution obtained in step (4)+an amount of the fusion protein in a solution after solid separation in step (3)}]×100; (3) separating a solid from the solution obtained in step (2); and (4) dissolving the solid separated in step (3) into a solution having a pH of 12 or below but higher than the pH of the solution obtained in step (2) by 0.

Abstract: Expression vector systems are provided for increased production of a recombinant GDF-5 (rhGDF-5) protein. Also provided are transformed host cells that were engineered to produce and express high levels of rhGDF-5 protein. Methods for production and high expression of rhGDF-5 protein are disclosed herein. The methods of enhancing production and protein expression of rhGDF-5 protein as disclosed are cost-effective, time-saving and are of manufacturing quality.

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: 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: 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: A method for manufacturing an antibody formulation in which DNA contaminants are removed by binding the antibody to a protein-A or probtin-G affinity column and eluting the antibody with an acidic eluting solution, preferably of low conductivity.

Abstract: The invention provides inhibitors of influenza endonuclease activity and tools for their discovery.

Abstract: The present invention provides a method of increasing protein production in a cell culture by growing cells that produce the protein (e.g., the growth phase) in a perfusion cell culture to a high cell density (i.e., at least above about 40×106 cells/mL) and then switching to a protein production phase, wherein the cells are cultured in a fed-batch cell culture. The present invention further provides a method for clarifying a protein from a cell culture by adjusting the pH of the cell culture to below neutral pH (i.e., below a pH of 7) and settling the cell culture, such that the cell culture separates to form a supernatant layer and a cell-bed layer, wherein the protein is in the supernatant layer.

Abstract: The invention relates to a method of treating or preventing disease associated with ?-amyloid polypeptides comprising administration of an immunoglobulin preparation enriched in immunoglobulin M (IgM), and pharmaceutical compositions comprising such preparations.

Abstract: Precipitated bacterial capsular polysaccharides can be efficiently re-solubilized using alcohols as solvents. The invention provides a process for purifying a bacterial capsular polysaccharide, comprising the steps of (a) precipitation of said polysaccharide, followed by (b) solubilization of the precipitated polysaccharide using ethanol. CTAB can be used for step (a). The material obtained, preferably following hydrolysis and sizing, can be conjugated to a carrier protein and formulated as a vaccine. Also, in vaccines comprising saccharides from both serogroups A and C, the invention provides that the ratio (w/w) of MenA saccharide:MenC saccharide is >1.

Abstract: The present invention provides compositions and pharmaceutical formulations of IaIp derived from plasma. Also provided are methods for the manufacture of the IaIp compositions and formulations, as well as method for the treatment of diseases associated with IaIp dysfunction.

Abstract: A pharmaceutical composition for treating or preventing a Th2-mediated disease or disorder includes live, killed or attentuated Franciscella tularensis or its components. The F. tularensis cells may be LVS cells. Administration of an effective amount may prevent or reduce bronchoconstriction or allergic airway inflammation through a T-helper cell (Th) 1-mediated suppression of an ongoing Th2 response mechanism.

Abstract: The invention provides methods and apparatus for the selective isolation of phosphorylated and glycosylated proteins and their fragments. Metal cation is used to precipitate proteins or protein fragments containing phospho groups and/or glyco groups. The sample preparation method can be used for several types of biological samples, including HeLa cells, food, and human cerebrospinal fluid. The proteins are isolated, recovered and ready for analysis by mass spectrometry or other analytical methods allowing detection limits down to the femtomole level. The method and apparatus are valuable tools in the field of protein analysis and diagnostics.

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: The present invention provides the method of obtaining IgA and IgM antibodies from chicken egg whites. The method involves separating chicken egg whites into two fractions which contain IgA and IgM antibodies exclusively. This separation method consists of raising the volume of the egg whites using purified water, lowering the pH of said volume, filtering the IgM fraction from said volume, precipitating the IgA fraction from the remaining volume, dialyzing the IgA fraction and drying the IgA and IgM fractions.

Abstract: The invention is related to a process for separating proteins fibrinogen, Factor XIII and biological glue from a solubilized plasma fraction and for preparing freeze-dried concentrates of said proteins comprising the steps of: chromatographic purification comprising the steps of loading an anion exchanger of weak base type with the said solubilized fraction, previously equilibrated with a buffer of a predetermined ionic strength of an alkaline pH, which allows to retain the biological glue, elution of the biological glue by increasing the ionic strength of the said buffer, and separation of FXIII from fibrinogen by addition to at least one part of the biological glue eluate of at least one chemical agent precipitating the FXIII, and recovery of the resulting purified fibrinogen containing supernatant solution, and diafiltration of the fibrinogen, biological glue and resolubilized FXIII solutions, followed by a freeze-drying of said solutions.

Abstract: The present invention provides method for purifying a recombinant protein from a gram-negative bacterial host cell sample or extract thereof wherein said host cell expresses a recombinant protein and a recombinant disulphide isomerase DsbC; comprising: a. adjusting the pH of the host cell sample or extract thereof to a pH of 5 or less to precipitate the recombinant disulphide isomerase; and b. separating precipitated recombinant disulphide isomerase DsbC from the recombinant protein to produce a recombinant protein sample.

Abstract: A method of preparing anti-b amyloid immunoglobulin involves treating human plasma anti-b amyloid immunoglobulin under alkaline conditions, such as at pH 10.25 to 11.75 using diethylamine HCl, to dissociate b amyloid protein therefrom. Typically, the anti-b amyloid immunoglobulin is present in human immunoglobulin preparations obtained from plasma or serum. Anti-b amyloid immunoglobulin prepared by the method is substantially free of b amyloid protein and has therapeutic activity in compositions and/or methods for treating a disease or condition associated with b amyloid plaques, such as Alzheimer's disease.

Abstract: A method for isolating crystals of perforin including the step of: crystallising perforin from solution at pH 6.4 to 8.0 and 20±5° C.

Abstract: The present invention relates to methods for rapid crystallization of amino acids, drug molecules, proteins and DNA/peptides. One method for rapid crystallization of functional group-containing molecules selected from the group consisting of amino acids, drug molecules, proteins and DNA/peptides includes (A) providing at least one metal or metal oxide in particulate or thin film form to provide (a) selective nucleation sites for crystallization of the functional group-containing molecules due to interactions of their functional groups and metal surfaces or engineered metal surfaces and (b) a microwave-transparent medium to create a thermal gradient between the metal surfaces or engineered metal surfaces and a warmer solution containing functional group-containing molecules to be crystallized, and (B) conducting microwave heating to cause the functional group-containing molecules to be crystallized.

Abstract: The present invention provides a Sortilin crystal and methods for growing said crystal. The invention furthermore provide methods for design of specific ligands based on the crystal structure of Sortilin. The present invention also relates to the preparation and use of such ligands for the preparation of a medicament for the treatment of disease, damage or disorders of the central and peripheral nervous systems.

Abstract: Methods and apparatus for processing corn into one or more corn products. Oil is extracted from corn or corn products or by-products with a solvent. The corn-solvent mixture is separated into streams, one of which preferably includes an extract containing at least oil and solvent, and another containing de-oiled corn solids and adsorbed solvent. Zein is separated from the de-oiled corn solids. Solvent is then separated, and the de-oiled, de-zeined, desolventized corn solids are processed to provide one or more corn products.

Abstract: Methods and apparatus for processing corn into one or more corn products. Zein is extracted from corn or corn products or by-products with a solvent. The corn-solvent mixture is separated into streams, one of which preferably includes an extract containing at least zein and solvent, and another that contains de-zeined corn solids and adsorbed solvent. The solvent is separated from the zein, and the de-zeined, desolventized corn solids are processed to provide one or more corn products.

Abstract: A novel canola protein product consisting predominantly of 2S canola protein and having improved solubility properties, has an increased proportion of 2 S canola protein and a decreased proportion of 7S canola protein, and a protein content of less than about 90 wt % (N×6.25) d.b. The novel canola protein isolate is formed by heat treatment or isoelectric precipitation of aqueous supernatant from canola protein micelle formation and precipitation, to effect precipitation of 7S protein which is sedimented and removed.

Abstract: The invention provides systems, methods and kits for the separation and/or purification of at least two cellular components selected from genomic DNA, RNA and proteins. The method includes first lysing a biological sample to generate an aqueous solution containing the cellular components; then applying the aqueous solution to a first mineral support under conditions for genomic DNA to bind; and collecting the flowthrough which contains unbound total RNA and proteins. The method further includes applying the flowthrough to a second mineral support under conditions for RNA to bind, and collecting the flowthrough which contains proteins. The genomic DNA and total RNA bound can be eluted while the protein in the flowthrough can be further purified. Further the total RNA isolated could be used to isolate small RNA such as microRNA.

Abstract: A method of oil extraction and biomass recovery from microalgae is disclosed. Methods according to the invention extract lipids from a biomass source and concentrate protein in the solid biomass source by alcohol processing. Aqueous alcohol processing methods provide extraction and separation techniques for lipids and protein-rich biomass suitable for biofuels.

Abstract: The invention relates to soluble selenium compositions and methods of production, separation and purification thereof. In particular the present invention provides methods of preparing water soluble selenoglycoproteins (e.g., via extracting selenoglycoproteins from selenium enriched yeast), methods of supplementing a selenium deficient composition via admixing water soluble selenoglycoproteins with the selenium deficient composition, compositions comprising the water soluble selenoglycoproteins and methods of administering the same.

Abstract: The present methods relate to the isolation and concentration of proteins using cross-flow membrane filtration, and to proteins produced by such methods. A feature of the method is that the protein of interest is retained by a cross-flow membrane under certain conditions that promote retention, while under other condition the protein passes through the membrane.

Abstract: Methods and systems for monitoring and/or controlling protein separation, purification, extraction, and/or fractionation processes are provided. The impedance of a protein mixture undergoing a protein process is measured and compared to a target reference impedance value or range of reference impedance values. If the measured impedance is not within an acceptable deviation of the target reference impedance value, a parameter of the protein mixture or process is adjusted.

Abstract: Microspheres are produced by contacting an aqueous solution of a protein or other macromolecule with an organic solvent and a counterion, and chilling the solution. The microspheres are useful for preparing pharmaceuticals of defined dimensions.

Abstract: The invention provides methods for a purifying protein of interest from a mixture comprising the protein of interest and one or more contaminants, including host cell DNA and proteins, by precipitation of the contaminants with caprylic acid. Such methods are particularly useful for purifying antibodies from cell cultures. Moreover, mixtures that have been depleted of contaminants using the methods of the invention can be used directly in downstream chromatography applications (e.g., ion exchange chromatography) without any further purification. These methods lead to manufacturing processes with a minimum number of unit operations and reduce the resource requirements, and thus positively influence the cost of goods for therapeutic protein production.

Abstract: Provided are new methods for precipitating proteins comprising (a) providing a protein solution, (b) adding a salt to the solution, (c) either (i) adjusting pH of the composition to below the pI of the protein (in cases where the method is directed towards precipitation of most or all proteins in the solution) or (ii) adjusting the pH of the composition to above the pI of the protein (in cases where keeping the target protein in solution is desired), and (d) adding an organic compound to the solution, wherein (I) in the case where the method comprises step (c)(i) a two phase solution is formed wherein at least about 75% of the protein is contained in the protein phase or (II) in the case where the method comprises step (c)(ii) the method further comprises removing precipitated impurities from the protein solution.

Abstract: The present invention relates to a method for separating protein from food by using an iso-electric point precipitation, comprising: obtaining a protein extract by adjusting pH of a raw material food in a media; precipitating the protein by adjusting pH of the protein extract to an iso-electric point of the desired protein; and recovering the protein precipitated after separating a protein filtrate through centrifuging the precipitated protein; in which the method may further include a heat-precipitation of the protein by heating the protein extract or the protein filtrate to 60˜145° C. The protein obtained in high yield according to the above method can be used as a food additive or a food nutritional enhancer.

Abstract: The present invention is directed to methods of diagnosing a disease or predicting an increased risk of a disease, such as obesity, obesity-dependent subacute inflammation, atherosclerosis, cardiovascular disease and a metabolic disease, by determining the levels of omentin 1 and 2 protein in a subject, or by determining the levels of omentin 1 and 2 gene expression in a subject. The present invention is also directed to methods of disease treatment using omentin 1 protein and omentin 2 protein.

Abstract: The present invention relates generally to Apo2L/TRAIL purification involving crystallization.

Abstract: The present invention aims to express influenza virus RNA polymerase on a large scale, to crystallize the influenza virus RNA polymerase, and to provide a method for screening a substance capable of serving as an active ingredient in anti-influenza drugs. The present invention provides a complex comprising a polypeptide consisting of an amino acid sequence at positions 678-757 of the RNA polymerase PB1 subunit in influenza A/Puerto Rico/8/34 H1N1 and a polypeptide consisting of an amino acid sequence at positions 1-37 of RNA polymerase PB2 subunit in influenza A/Puerto Rico/8/34 H1N1. This complex can be crystallized in the presence of a precipitant such as potassium phosphate and PEG4000. Moreover, with the use of information on the crystal structure of this complex, it is possible to provide a method for screening a substance capable of serving as an active ingredient in anti-influenza drugs.

Abstract: The present invention comprises methods and systems for manipulation of media and particles, whether inert materials or biomaterials, such as cells in suspension cell culture. The methods and systems comprise use of an apparatus comprising a rotating chamber wherein the actions of the combined forces of gravity, fluid flow force and centrifugal force form a fluidized bed within the rotating chamber.

Abstract: The present invention comprises methods and systems for manipulation of media and particles, whether inert materials or biomaterials, such as cells in suspension cell culture. The methods and systems comprise use of an apparatus comprising a rotating chamber wherein the actions of the combined forces fluid flow force and centrifugal force form a fluidized bed within the rotating chamber.

Abstract: Devices and methods are provided for reducing matrix effects in protein precipitated bioanalytical samples comprising: a support, and a sorbent associated with the support capable of binding matrix interfering agents present in the bioanalytical sample, wherein the device further comprises filtering means for removing precipitated protein particles. The filtering means is a size exclusion filter or a polymeric or inorganic monolith having a maximum pore size less than or equal to the diameter of the particles to be removed from the sample, and can be integral with the sorbent or associated with the sorbent. The sorbent is characterized by sufficient selectivity between the matrix interfering agents and analytes of interest to provide retention of the matrix interfering agents while providing elution of the analytes of interest (e.g., a reversed phase or a polar modified reversed phase).

Abstract: This invention relates to SPPs, spherical nanocrystalline composite particles or crystalline SPPs of biologically active proteins or compositions, including formulations, comprising such SPPs, spherical nanocrystalline composite particles or crystalline SPPs. More particularly, methods are provided for the production of SPPs, spherical nanocrystalline composite particles or crystalline SPPs of high concentrations of biologically active proteins, and for the preparation of stabilized SPPs, spherical nanocrystalline composite particles or crystalline SPPs for use alone, or in dry or slurry compositions. This invention also relates to methods for stabilization, storage and delivery of biologically active proteins using SPPs, spherical nanocrystalline composite particles or crystalline SPPs.

Abstract: A composition-of-matter is provided. The composition comprising at least one antibody binding moiety capable of binding an antibody-labeled target molecule, cell or virus of interest, said at least one antibody binding moiety being attached to at least one coordinating moiety selected capable of directing the composition-of-matter to form a non-covalent complex when co-incubated with a coordinator ion or molecule.

Abstract: A method for extracting an intracellular peptide, protein or other polypeptide from a whole fermentation broth using a water miscible alcohol, or a water miscible or partially water miscible glycol ether.

Abstract: The invention relates to a method for separating fibronectin from plasma fractions by adjusting a pH value of less than 5.4 such that fibronectin is precipitated and extracted from the solution.

Abstract: An improved process for the purification of antibodies from human plasma or other sources is disclosed. The process involves suspension of the antibodies at pH 3.8 to 4.5 followed by addition of caprylic acid and a pH shift to pH 5.0 to 5.2. A precipitate of contaminating proteins, lipids and caprylate forms and is removed, while the majority of the antibodies remain in solution. Sodium caprylate is again added to a final concentration of not less than about 15 mM. This solution is incubated for 1 hour at 25° C. to affect viral inactivation. A precipitate (mainly caprylate) is removed and the clear solution is diluted with purified water to reduce ionic strength. Anion exchange chromatography using two different resins is utilized to obtain an exceptionally pure IgG with subclass distribution similar to the starting distribution. The method maximizes yield and produces a gamma globulin with greater than 99% purity. The resin columns used to obtain a high yield of IgG retain IgM and IgA.