Abstract: The present invention provides processes for the manufacturing of polypeptide conjugates. In particular, the invention provides methods for the purification of polypeptide conjugates, which include at least one polymeric modifying groups, such as a poly(alkylene oxide) moiety. Exemplary poly(alkylene oxide) moieties include poly(ethylene glycol) (PEG) and poly(propylene glycol). In an exemplary process, hydrophobic interaction chromatography (HIC) is used to resolve different glycoforms of glycoPEGylated polypeptides.

Abstract: The present invention relates to the manufacture of recombinant antibodies of therapeutic quality. In particular, the invention relates to methods for increasing the yield of functional antibody from large scale fermentations whereby a cultured host cell sample is subjected to a non-lysing treatment.

Abstract: The present invention provides a method for purification of a virus or virus antigen comprising providing a virus preparation and centrifugation of said virus preparation in a gradient of a sugar established by the addition of two or more buffered sugar layers of different concentration. The method leads to higher yields and reduces unwanted aggregation of the virus or virus antigen by increasing the volume of the peak pool.

Abstract: A method is provided for extraction of chemical compounds from an organism having a cell wall that includes adding nanomaterials, which may be metallic nanofibers such as silver nanofibers, to the organism.

Abstract: Fully human monoclonal Abs includes (i) an antigen-binding variable region that exhibits very high binding affinity for IL-1? and (ii) a constant region that is effective at both activating the complement system though C1q binding and binding to several different Fc receptors.

Abstract: A process for manufacturing of a composition containing a purified factor for supporting wound healing selected from the group consisting of Hepatocyte Growth Factor (HGF) platelet derived growth factor (PDGF), Epidermal growth factor (EGF), transforming growth factor alfa (TGF-?), Transforming growth factor beta (TGF-?), insulin like growth factor (IGF-I) and Fibroblast growth factor (FGF) from sources, such as blood, containing the factor for supporting wound healing, wherein the manufacturing process comprises purification steps which are performed in the presence of antithrombin III (AT-III).

Abstract: The present invention relates to a solid support having a heat-resistant biotin-binding protein attached thereto. The present invention also relates to the use of the solid support of the present invention having a heat-resistant biotin-binding protein attached thereto. The present invention further relates to technical fields such as purification, concentration, detection and/or capture of a biotin-linked substance by means of a heat-resistant biotin-binding protein. Such a biotin-binding protein used in the solid support of the present invention is heat-resistant and is therefore useful for use in assay systems involving exposure to a temperature of 70° C. or more.

Abstract: A method is provided for producing soluble thrombomodulin substantially not containing a denatured product of the soluble thrombomodulin that is generated under acidic conditions, which comprises: subjecting the soluble thrombomodulin-containing material to an anion exchanger or hydroxyapatite; and carrying out linear gradient elution, stepwise gradient elution, or gradient elution in which linear gradient elution is combined with stepwise gradient elution under separation conditions in which the denatured product of the soluble thrombomodulin can be separated, wherein the gradient is a salt concentration gradient, so as to obtain an elution fraction containing soluble thrombomodulin that does not substantially contain the denatured product of the soluble thrombomodulin, either (a) after the position of a fraction has previously been confirmed, or (b) while confirming the elution fraction.

Abstract: The present invention discloses methods of neutralizing apatite surfaces, for example during chromatography and before protein elution.

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 is directed to methods for purifying a protein of interest, e.g., an antibody, from a sample comprising the protein of interest and at least one impurity, e.g., an aggregate, by employing a hydrophobic interaction chromatography (HIC) method that allows for binding of both the protein of interest and the at least one impurity under strong binding conditions. The present invention is based, at least in part, on the finding that both flow through and bind-elute techniques can be combined to achieve greater purification and recovery of a protein of interest, e.g., an antibody, under isocratic wash conditions and strong binding conditions.

Abstract: Compositions, methods, articles of manufacture, and kits are provided for storage and delivery of proteins.

Abstract: The present invention relates to a novel protocol for making a hydrogel, which shows increased stability compared to hydrogels of the art, and can be reliably reproduced. The hydrogels produced by the methods of the present invention are preferably three dimensional, and particularly suitable for the culture of stem cells.

Abstract: The invention includes a process for extracting a target protein from Escherichia coli cells that includes lowering the pH of a whole E. coli cell solution to form an acidic solution, disrupting the cells to release the protein into the acidic solution, and separating the cellular debris from the released protein to obtain a protein product enriched in the heterologous target protein. The invention also includes addition of a solubility enhancer.

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 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 invention provides a process for preparing a cell-binding agent chemically coupled to a drug. The process comprises covalently attaching a linker to a cell-binding agent, a purification step, conjugating a drug to the cell-binding agent and a subsequent purification step.

Abstract: Provided herein are compositions comprising native and denatured human leukocyte antigens (HLA) and methods of making said compositions. Also provided herein are methods and kits for the detection of antibodies to native HLAs.

Abstract: The present invention relates to a process for the purification of a protease.

Abstract: Methods of expressing LIM mineralization protein in mammalian cells are described. Methods of expressing LIM mineralization protein and assessing glycosylation of the LIM mineralization protein in prokaryotic and non-mammalian eukaryotic cells are also described. The methods involve transfecting the cells with an isolated nucleic acid comprising a nucleotide sequence encoding a LIM mineralization protein. Transfection may be accomplished in vitro, ex vivo or in vivo by direct injection of virus or naked DNA, or by a nonviral vector such as a plasmid.

Abstract: The present invention features improved methods of in vitro RNA display to allow reliable expression and selection of scFv antibody molecules from expression libraries. The improved methods, in part, involve the use of mildly reducing conditions, which favor of scFv intra-chain disulphide bond and thus correct folding of the scFv antibody molecules. Although particularly suited to expression and selection of scFv antibody molecules, the methods of the invention are also expedient for in vitro RNA display of all classes of protein.

Abstract: The present invention provides isolated polypeptides having oligopeptide permease activity and an amino acid sequence that has at least 80% identity with a Haemophilus parasuis OppA polypeptide. Also provided by the present invention are isolated polynucleotides that encode the polypeptides described herein, and antibody that specifically binds a polypeptide described herein. The present invention further provides genetically modified microbes, such as attenuated Haemophilus parasuis strains and other microbes that express polypeptides described herein. Also included are methods for using the polypeptides, polynucleotides, antibody, and genetically modified microbes.

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 relates to a process for obtaining a rabbit skin containing biologically active substances. The rabbit skin extract is obtained by the process including vaccinating a rabbit subcutaneously with vaccinia virus, feeding the rabbit, killing the rabbit when the skin is inflamed, skinning the rabbit within 15 minutes of death, preserving the rabbit skin at ?18 degrees Celsius, extracting a portion of the rabbit skin with a phenol solution at 4° C., processing the rabbit skin extract with an acid and an alkali, eluting the rabbit skin extract and fractioning under a nitrogen atmosphere the eluted portion of the rabbit skin extract. The rabbit skin of the present invention can be used for preparing drugs and health foods.

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: A protocol for pasteurizing microbial cells is disclosed. The protocol has three stages, a first heating stage, a second plateau stage at which the cells are held at a (maximum and) constant temperature, and a third cooling stage. The heating and cooling stages are rapid, with the temperature of the cells passing through 40 to 80° C. in no more than 30 minutes in the heating stage. The heating rate is at least 0.5° C./minute and during cooling is at least ?0.5° C./minute. The plateau maximum temperature is from 70 to 85° C. By plotting the pasteurization protocol on a time (t, minutes) versus temperature (T, ° C.) graph, a trapezium is obtained having an area less than 13,000° C. minute. This results in a smaller energy input and a better quality oil results having a peroxide value (POV) of less than 1.5 and an anisidine value (AnV) of less than 1.0.

Abstract: The present invention relates to a chromatography ligand defined by the following formula R1—R2—N(R3)—R4—R5 wherein R1 is a substituted or non-substituted phenyl group; R2 is a hydrocarbon chain comprising 0-4 carbon atoms; R3 is a hydrocarbon chain comprising 1-3 carbon atoms; R4 is a hydrocarbon chain comprising 1-5 carbon atoms; and R5 is OH or H. The invention also comprises a separation matrix, comprising the described ligands coupled to a porous support, such as particles or a membrane. The ligand and matrix according to the invention is useful for purification of biomolecules or organic compounds, such as proteins, polypeptides, DNA etc. An advantageous use according to the invention is the purification of antibodies.

Abstract: A protein product recovered from a fermentation process including a protein content of 45.0% or more calculated by weight of dry matter, a glycerol content of 1.0% or less calculated by weight of dry matter, and a mineral nutrient content of 6.0% or less calculated by weight of dry matter. A method for recovering a protein product by heating fermentation stillage to 200 degrees F.-350 degrees F., altering the physicochemical properties of the stillage to enable facile separation of the stillage, and separating a phase enriched in protein. Protein products, protein paste, high protein meal, and proteinaceous agglomerates recovered and formed.

Abstract: A method for producing a crystalline and/or amorphous metabolite suspension from a cell fermentation broth in a continuous centrifuge process comprising (a) adding at a separate inlet to the centrifuge the fermentation broth comprising the cells and the metabolite of interest, wherein the metabolite is partly or wholly on crystalline and/or amorphous form; (b) adding at another inlet to the centrifuge an aqueous liquid comprising a salt and/or a carbohydrate having a higher density than the cells and a lower density than the metabolite of interest in its precipitated form; (c) removing the cells at a separate outlet to the centrifuge; and (d) removing the suspension comprising the crystalline and/or amorphous metabolite of interest at another outlet to the centrifuge.

Abstract: A fusion protein that includes a polypeptide binding specifically to a constant region of an antibody and a stabilization protein linked to a terminus of the polypeptide, a polynucleotide encoding the fusion protein, a cell including the polynucleotide, a method of preparing the fusion protein, and a method of isolating an antibody by using the fusion protein.

Abstract: The present invention is method for non-covalently immobilizing an infectious prion protein using a magnetic substrate.

Abstract: The present invention provides an antibody-immobilized carrier that can be used in antibody screening, a method of producing the antibody-immobilized carrier, and use of the antibody-immobilized carrier. Efficient antibody screening can be carried out particularly by an antibody-immobilized carrier including two or more antibody immobilized regions onto each of which a heavy-chain low-molecular-weight antibody and a light-chain low-molecular-weight antibody are separately immobilized, the two or more antibody immobilized regions each being included in an independent manner, the heavy-chain low-molecular-weight antibody including a heavy-chain variable region, the light-chain low-molecular-weight antibody including a light-chain variable region, the heavy-chain low-molecular-weight antibody and the light-chain low-molecular-weight antibody each being derived from an antibody recognizing a different antigen.

Abstract: A series of multi-dimensional acoustic standing waves is set up inside a growth volume of a bioreactor. The acoustic standing waves are used to hold a cell culture in place as a nutrient fluid stream flows through the cell culture. Biomolecules produced by the cell culture are collected by the nutrient fluid stream and separated downstream of the cell culture.

Abstract: Disclosed are compositions and methods for isolating proteins from lipids. The isolation methods may utilize derivatives of apolipoprotein A1 for isolating membrane proteins from membranes without the use of detergent.

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: Methods useful for producing a solution of purified Fc peptide chains are disclosed. The methods employ protein A chromatography to separate high molecular weight, aggregated peptide chains comprising antibody Fc domains from lower molecular weight unaggregated peptide chains that also comprise antibody Fc domains. The solutions of purified Fc peptide chains obtained by the methods of the invention contain less than 5% aggregate and greater than 70% of the Fc peptide chains subjected to purification.

Abstract: An assembly capable of capturing and purifying expressed biological products during or at the end of a bioreaction cycle is disclosed wherein a binding resin is kept separated from the contents of the bioreactor allowing capturing, harvesting and purification of biological products in a bioreactor; the invention additionally provides means of removing undesirable metabolic products as well as provides for efficient loading of chromatography columns.

Abstract: The present invention relates to a process for the purification of a glycoprotein comprising subjecting a liquid containing said glycoprotein to the steps of: a) reverse phase chromatography, b) size exclusion chromatography, and c) hydrophobic interaction chromatography. Also provided is a manufacturing process for producing a glycoprotein of interest.

Abstract: An affinity chromatography packing material includes porous mother particles that include a copolymer of a monomer mixture including a crosslinkable vinyl monomer and an epoxy group-containing vinyl monomer, a ligand being bound to the porous mother particles, and the porous mother particles including a ring-opening epoxy group produced by ring-opening of the epoxy group included in the porous mother particles.

Abstract: The present invention relates to the discovery that of a panel of serum or plasma markers may be used to diagnose Idiopathic Pulmonary Fibrosis (“IPF”) and distinguish this condition from other lung ailments. It further relates to the identification of markers associated with IPF disease progression.

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: A method for purifying bone-derived osteoinductive proteins including a demineralization process, a protein extraction process, a high molecular weight ultrafiltration process, a low molecular weight ultrafiltration process, and a recover process. The high and low ultrafiltration processes preferably select proteins having a nominal molecular weight between approximately 8 kilodaltons and approximately 100 kilodaltons. Processes of the present invention may be used to recover osteoinductive proteins from bone demineralization waste streams.

Abstract: Herein is reported a tangential flow filtration method with a pre-filtration solute concentration adjustment in order to ensure a defined concentration of the components of the solution after tangential flow filtration.

Abstract: The present invention provides a process for purifying FV starting from human plasma or a fractionation intermediate thereof, that is simple, scalable to the industrial level and relatively inexpensive compared to the methods described in the literature to date. The invention consists of the use of two anion exchange chromatography steps, the first of which has the purpose of separating the FV from the PTC component factors, while the second has the purpose of isolating the protein of interest from the majority of plasma proteins by means of selective interaction with the weak anion exchange support used. The process developed has also had a viral inactivation step and a viral removal step included, contributing to the safety of the final product obtained, without however significantly altering the process total recovery of FV, and without necessitating the introduction of additional steps for eliminating the inactivating agents used, thanks to the order in which the various steps are conducted.

Abstract: The identification and evaluation of mRNA and protein targets associated with mRNP complexes and implicated in the expression of proteins involved in common physiological pathways is described. Effective targets are useful for treating a disease, condition or disorder associated with the physiological pathway.

Abstract: The present invention relates to a method for providing an isolated biofuel and a purified protein product from a raw material suitable for the production of the biofuel or a derivative of said raw material. The method comprises the steps of: (i) subjecting the raw material or a derivative of said raw material to at least one first treatment liberating the biofuel from the raw material or the derivative of said raw material, (ii) isolating the biofuel liberated in step (i) obtaining the isolated biofuel, (iii) subjecting the raw material or a derivative of said raw material to at least one second treatment providing a material suspension, and (iv) subjecting the material suspension from step (iii) to an expanded bed adsorption process obtaining the purified protein product.

Abstract: The present invention relates to methods for the release of baculovirus-expressed Virus-like Particles (VLP's) of non-enveloped viruses from insect cells.

Abstract: A solid substrate for the extraction, stabilization, and storage of proteins is provided. The substrate includes: a polysaccharide, such as melezitose under a substantially dry state. The substrate is configured to extract proteins from a sample and stabilize the extracted proteins in a dry format under ambient conditions for a prolonged period of time. Methods for collecting and recovering the proteins stored in the dry solid substrate are also described.