Abstract: A flow-through process for separating protein monomer from aggregates of that protein in a solution containing both protein monomer and aggregates of that protein, the process includes the steps of 1) contacting the solution at a pH of from 4 to 7 with a weak anion exchange media comprised of multiple primary, secondary and/or tertiary amine functionalization groups whereby the protein monomer flows through the media without binding thereto and the aggregates are retained on the media, and 2) collecting the flow-through as purified protein monomer.

Abstract: Removal of genomic DNA from biological samples using cation exchange is described.

Abstract: The invention is directed to a method for purifying a protein. The method involves providing a sample containing the protein, processing the sample through a capture chromatography resin, inactivating viruses in the sample, and processing through at least one depth filter and ion-exchange membrane.

Abstract: The invention relates to a method of purifying PEGylated proteins by removing impurities from samples containing PEGylated proteins, in particular, but not exclusively vitamin K-dependent blood coagulation factors such as Factor IX (FIX), to proteins purified by said method and to the use of said purified proteins in therapy, in particular but not exclusively, for the treatment of diseases alleviated by blood coagulation factors such as the prophylactic treatment of hemophilia.

Abstract: Disclosed is both a method for preparing a plasminogen and a method for preparing a reversibly inactive acidified plasmin by activating the plasminogen. The prepared plasminogen is typically purified from a fraction obtained in the separation of immunoglobulin from Fraction II+III chromatographic process and eluted at a low pH. The prepared plasmin is isolated and stored with a low pH-buffering capacity agent to provide a substantially stable formulation. The reversibly inactive acidified plasmin may be used in the administration of a thrombolytic therapy.

Abstract: It is an object of the present invention to obtain a soluble thrombomodulin substantially not containing a denatured product of soluble thrombomodulin that may be generated under acidic conditions.

Abstract: The invention provides a method for producing a host cell protein-(HCP) reduced antibody preparation from a mixture comprising an antibody and at least one HCP, comprising an ion exchange separation step wherein the mixture is subjected to a first ion exchange material, such that the HCP-reduced antibody preparation is obtained.

Abstract: A method of separating a selected ionic component from a sample, comprises contacting the sample with an ionic adsorbent whose charge density is such that the component is bound selectively in the absence of added ionic component that competitively binds the adsorbent.

Abstract: The present invention provides improved methods of protein purification using CEX chromatography. Such methods generally comprise the steps of: contacting a protein of interest (e.g., an antibody) with a cation exchange resin at a first pH, that is less than the pI of the most acidic isoform of the protein of interest, such that the protein of interest binds to the resin; washing the cation exchange resin at a second pH that is greater than the first pH, but less than the pI of the most acidic isoform of the protein of interest; and eluting the protein of interest from the resin at a third pH that is about equal to or less than the first pH. The methods of the invention are particularly useful for the commercial purification of recombinant therapeutic proteins (e.g., antibodies).

Abstract: Biologically active tetrameric p53 proteins and p53 fusion proteins are provided. These proteins may be generated and refolded into tetrameric form using denatured proteins produced from E. coli. Therapeutic uses of p53 proteins and p53 fusion proteins are also provided.

Abstract: The present invention provides methods for purifying proteins. In particular, the methods employ a two-step non-affinity chromatography process without the use of an in-process tangential flow filtration step.

Abstract: The invention provides methods for the preparation of an isolated virus particle or virus-like particle by treating with an agent such that the particles are preferentially in the aqueous phase. The invention also provides methods of preparing a capsomere that is substantially-free of at least one host cell derived chaperone protein by treatment with an agent to selectively separate the capsomere from at least one chaperone protein.

Abstract: Methods of reducing high molecular weight species (HMW) formation in a sample containing a protein purified using ion exchange (IEX) chromatography are disclosed, as are a number of related methods, e.g., methods of reducing on-column denaturation of a protein in a protein sample purified using an ion exchange (IEX) column or resin. The methods share characteristics of including arginine, glycine and/or histidine in the buffers used during the ion exchange (IEX) chromatography.

Abstract: The present invention provides an improved method for the purification of a mixture of complexes comprising a stress protein complexed to a peptide or peptide fragment from a source mixture, typically a cell lysate. The method of the invention provides for protein complexes to be purified using ion exchange chromatography based methods, wherein a modified buffer solution is used which results in the purified stress protein complexes being more immunogenic than protein complexes obtained using conventional methodology. The purified complexes can be used to produce improved vaccine preparations which elicit enhanced immune responses in the subjects to whom the vaccine compositions are administered.

Abstract: The present invention relates to compositions and methods for the chromatographic purification of antibodies, such as monoclonal antibodies, employing improved simulated moving bed separation strategies and, in certain embodiments, Raman spectroscopy.

Abstract: The present invention relates generally to the production, purification, and isolation of human growth hormone (hGH). More particularly, the invention relates to the production, purification, and isolation of substantially purified hGH comprising non-naturally encoded amino acids and hGH from recombinant host cells or culture medium including, for example, yeast, insect, mammalian and bacterial host cells. The process of the present invention is also useful for purification of hGH linked to polymers or other molecules.

Abstract: The present invention mainly relates to a process for isolation and purification of yolk antibodies from egg yolk of an anseriform bird by an adsorption chromatographic procedure using a water insoluble non-charged absorbent to accomplish a desired separation of yolk antibodies, and by a salting-out procedure that differentially precipitates the IgY antibodies. The present invention also relates to the yolk antibodies produced thereby and various uses of such yolk antibodies.

Abstract: The present invention relates to a method for the purification of divalent cation binding proteins with high purity on an anion exchange resin material, to divalent cation binding proteins obtainable by said method, and to a kit comprising means for carrying out said method.

Abstract: The present disclosure relates to a field of recombinant DNA therapeutics. It involves the bio-informatics design, synthesis of artificial gene for human insulin precursor including leader peptide coding sequence, cloning in an expression vector and expression in an organism, preferably Pichia pastoris. The present disclosure also relates to methods of downstream processing for obtaining protein precursor molecules and subsequent conversion of precursor molecules to functional proteins.

Abstract: The invention is a method for the purification of mono-PEGylated erythropoietin using two cation exchange chromatography steps wherein the same type of cation exchange material is used in both cation exchange chromatography steps and a method for producing a mono-PEGylated erythropoietin in substantially homogeneous form.

Abstract: An atopic dermatitis inducer binding to a human own IgE antibody and activating mast cells and basophiles, which includes a purified human secretion fraction, or an antigenic molecule or an antigenic determinant in the purified fraction, and obtained through the following steps of: filtering a human secretion, removing insoluble matters and collecting the filtrate; mixing the filtrate with a ConA-affinity carrier and collecting the supernatant; and separating a component having a histamine-releasing activity from the supernatant by column chromatography. This inducer is effective in diagnosing and treating human atopic dermatitis.

Abstract: The present invention provides methods for purifying proteins. In particular, the methods employ a two-step non-affinity chromatography process without the use of an in-process tangential flow filtration step.

Abstract: The present invention relates to a method for isolating proteins from a solution containing the proteins. The invention also relates to a method for the chromatographic separation of proteins. The present invention also relates to crosslinked hydroxylic polymer particles functionalized with temperature-responsive copolymer, and to methods of preparing such particles.

Abstract: Adsorptive media for chromatography, particularly ion-exchange chromatography, derived from a shaped fiber. In certain embodiments, the functionalized shaped fiber presents a fibrillated or ridged structure which greatly increases the surface area of the fibers when compared to ordinary fibers. Also disclosed herein is a method to add surface pendant functional groups that provides cation-exchange or anion-exchange functionality to the high surface area fibers. This pendant functionality is useful for the ion-exchange chromatographic purification of biomolecules, such as monoclonal antibodies (mAbs).

Abstract: A process for purifying at least one product from a substrate containing at least one product, includes subjecting the substrate to centrifugal partition chromatography in an ion exchange displacement mode to purify the at least one product from the substrate, the at least one product being an amphoteric product.

Abstract: A chromatography column that captures components in a process liquid in a free flow state and allows elution in steps is described.

Abstract: The present invention relates to a process of enriching one target compound from a liquid, which process comprises at least one step of isolation performed by differentially partitioning between two aqueous phases. In the present invention the phases are formed by adding a thermally responsive, self-associating (i.e. clouding) hydrophilic polymer, and if needed some additional salts, to an aqueous biotechnical solution (such as a fermentation sample or bioseparation process stream) under thermal and other conditions where the solution separates into a one polymer, two-phase system with one phase enriched in the polymer. The target compound is to be found in the phase not enriched in the polymer, while a significant though varying percentage of contaminants may differentially partition to the phase interface or the polymer enriched phase.

Abstract: The invention discloses a purified albumin solution of human origin with low prekallicrein activator (PKA) activity and stability over time characterized in that it has an antithrombin content equal to or greater than 0.03 mg/g of albumin, and a process for production thereof by the partial extraction of the antithrombin during fractionation of the human plasma.

Abstract: The present invention relates generally to the production, purification, and isolation of human growth hormone (hGH). More particularly, the invention relates to the production, purification, and isolation of substantially purified hGH from recombinant host cells or culture medium including, for example, yeast, insect, mammalian and bacterial host cells. The process of the present invention is also useful for purification of hGH linked to polymers or other molecules.

Abstract: The invention is directed to an apparatus and method for purifying a protein. The apparatus involves the use of a capture chromatography resin, a depth filter arranged after the capture chromatography resin, and a mixed-mode chromatography resin arranged after the depth filter. The method involves providing a sample containing the protein, processing the sample through a capture chromatography resin, a depth filter, and a mixed-mode chromatography resin. A membrane adsorber or monolith may be substituted for the mixed-mode chromatography column.

Abstract: Processes are provided for recovering and purifying refolded recombinant proteins produced in heterologous host cells, which includes the step of refolding the protein in a high pH buffer.

Abstract: The present invention relates to an ion exchange chromatography process for purifying GLP-1 or an analog or a derivative thereof from a mixture containing said GLP-1 and related impurities, and to an industrial method including such ion exchange chromatography process.

Abstract: The invention relates to the purification of different gamma carboxylated forms of a polypeptide using ion exchange chromatography. In particular, the invention provides a method for purifying a polypeptide having a desired content of gamma-carboxyglutamic acid from a sample comprising mixture of species of said polypeptide having different contents of gamma-carboxyglutamic acid, said method comprising the steps of: (a) loading said sample onto an anion exchange chromatography material; (b) eluting said polypeptide using a solution at a pH of less than pH 9.0 comprising at least one salt selected from ammonium acetate, ammonium chloride and sodium acetate; and (c) selecting a fraction obtained from said elution wherein the polypeptides in the fraction have the desired content of gamma-carboxyglutamic acids.

Abstract: The invention claims a process for making an insulin-oligomer conjugate IN-105. IN-105 precursor having formula G-A-V-R-[B-Chain]-R-D-A-D-D-R-[A-Chain] is cloned and expressed in Pichia. The biosynthetic precursor is then conjugated with an activated oligomer. The IN-105 precursor-oligomer conjugate is then treated with protease and purified to afford active insulin-oligomer conjugate of formula insulin-OC—CH2—CH2—(OCH2CH2)3—OCH3.

Abstract: The present invention relates to a method for producing a mature von Willebrand Factor (VWF) from von Willebrand Factor pro-peptide comprising the steps: immobilizing VWF pro-peptide on an ion exchange resin, incubating the immobilized VWF pro-peptide with furin to obtain immobilized mature VWF, and isolating mature VWF from the ion exchange resin by elution.

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

Abstract: A method for purifying a polypeptide by ion exchange chromatography is described in which a gradient wash is used to resolve a polypeptide of interest from one or more contaminants.

Abstract: A object of the present invention is to provide an immunochromatography method that makes it possible to rapidly detect an ultratrace amount of an analyte that has been impossible to analyze by conventional immunochromatography methods. The present invention provides an immunochromatography method, which comprises developing an analyte and a labeling substance which is modified with a first binding substance against the analyte in a mixed state on a porous carrier and capturing the analyte and the label at a reaction site on the porous carrier having a second binding substance against the analyte or a substance capable of binding to the first binding substance against the analyte, so as to detect the analyte, wherein the labeling substance having an average particle size of 1 ?m or more and 20 ?m or less is detected.

Abstract: An ion-exchange chromatography support for reducing the ADAMTS13 amount present in a plasma-derived solution containing human von Willebrand factor. The support includes a large-pore, vinyl polymer-type resin bearing DEAE groups, and a buffer including trisodium citrate, sodium chloride, calcium chloride, glycine and lysine.

Abstract: Disclosed and claimed is a human erythropoietin (EPO) expressed and produced in Spodoptera frugiperda Sf900+ cell line (ATCC: CRL 12579) transfected with a baculovirus construct containing the EPO gene. The EPO has an in vivo activity of 200,000 U/mg to 500,000 U/mg.

Abstract: The invention relates to isolated or purified bacterial adhesin conformers, preferably with improved stability and/or immunogenicity. In a preferred aspect, the invention comprises an isolated bacterial adhesin conformer F. Also provided are methods of isolation and/or separation of such adhesin conformers. The compositions may include one or more of the immunogenic polypeptides either alone or with other antigenic components. For example, the immunogenic polypeptides may be combined with other bacterial antigens to provide therapeutic compositions with broader range.

Abstract: The present invention generally relates to novel processes for protein purification in high salt solutions such as cell culture broth by increasing the dynamic binding capacity of a resin with the addition of polyethylene glycol.

Abstract: The invention relates to a method for separating at least one non-aggregated protein from a liquid protein preparation by contacting said preparation with a multimodal anion exchanger in the presence of protein-excluded zwitterions at a concentration of 0.25 to 2.5 M.

Abstract: Expression systems are disclosed for the direct expression of peptide products into the culture media where genetically engineered host cells are grown. High yield was achieved with novel vectors, a special selection of hosts, and/or fermentation processes which include careful control of cell growth rate, and use of an inducer during growth phase. Special vectors are provided which include control regions having multiple promoters linked operably with coding regions encoding a signal peptide upstream from a coding region encoding the peptide of interest. Multiple transcription cassettes are also used to increase yield. The production of amidated peptides using the expression systems is also disclosed.

Abstract: Immunogenic compositions for use in treating, preventing and diagnosing infection caused by the California (CAL) serotype of the genus Bunyavirus, such as La Crosse virus (LACV), are disclosed. Also described are reagents for use in diagnostic assays.

Abstract: A method is provided for purifying protein having steps of loading a sample containing proteins into a column containing an ion exchanger in a first direction to allow the ion exchanger to absorb proteins; and passing a salt solution through the column in a second direction opposite to the first direction to elute a target protein from the ion exchanger. The method is proven as capable of improving homogeneity of eluted target protein without combining minute and complicated techniques for protein purification. Therefore, the method is convenient, efficient and economic for purifying proteins.

Abstract: The present invention relates generally to the production, purification, and isolation of human growth hormone (hGH). More particularly, the invention relates to the production, purification, and isolation of substantially purified hGH comprising non-naturally encoded amino acids and hGH from recombinant host cells or culture medium including, for example, yeast, insect, mammalian and bacterial host cells. The process of the present invention is also useful for purification of hGH linked to polymers or other molecules.

Abstract: The present invention provides methods for separating proteins from a protein mixture. In one aspect, a method for separating a high concentration protein mixture into a bound protein fraction and a flow-through protein fraction can include delivering a protein mixture through an ion exchange column at a fixed pH and a fixed salt concentration. The fixed pH and the fixed salt concentration have been preselected to cause separation of the protein mixture into a bound protein fraction and a flow-through protein fraction. In this case, the bound protein fraction binds to the ion exchange column and the flow-though protein fraction flows though the ion exchange column. The method can further include receiving the flow-through protein fraction from the ion exchange column separate from the bound protein fraction, wherein either the bound protein fraction or the flow-through fraction contains a protein of interest.

Abstract: Methods and systems for chromatographically purifying a botulinum neurotoxin are provided. These methods and systems allow for efficient purification of a non-complexed form of the botulinum neurotoxin in high purity and yield that can be used as an active ingredient in pharmaceutical preparations.

Abstract: The present invention provides methods for purifying Von Willebrand factor (VWF) for increased removal of non-lipid enveloped viruses.