Abstract: A method and vaccine for treatment of pythiosis in humans and animals is described. In particular a vaccine comprising a mixture of extracellular and intracellular proteins is described. The vaccine enables cures of chronic pythiosis in some patients.

Abstract: Solutions and methods are disclosed for the effective, simple isolation/extraction of DNA, RNA and proteins from a single biological material sample, such as cells, tissues and biological fluids. The preferred solutions include effective amounts of a chaotropic agent(s), buffer, reducing agent, and may or may not include an organic solvent. Genomic DNA and total RNA can be isolated utilizing the solutions and methods of the invention in as little as 20 minutes, and proteins in as little as 30 minutes.

Abstract: This invention describes the isolation and identification of a new protein, p56, useful for the identification of drugs that will selectively open or close K channels. The protein p56 has a molecular weight of about 56,000 daltons and the N-terminal peptide sequence is: Glu-Pro-Arg-Ala-Pro-Pro-Glu-Lys-Ile-Ala-Ile-Val-Gly-Ala-Gly-Ile.

Abstract: A process for the fractionation of proteins from an aqueous solution of whey is described. The process includes mixing the solution with carbon dioxide under pressure, heating the mixture to increase the pressure, releasing the pressure and lowering the temperature of the mixture, then separating a supernatant liquor from a precipitate which results from the process.

Abstract: A method of preparing a novel, sterile, receptor rich-albumin molecule which utilizes the disinfecting properties of iodine by reacting an iodine donating material or solution with a pure preparation of albumin, and preferably subsequently removing the iodine. The resulting iodine has improved binding properties because the production method strips bacterial endotoxin and other previously bound substances from the albumin. The improved binding site capacity of the albumin product is advantageously used as an adjunct in removing toxins by means of exchange transfusions. Because iodine disinfects the albumin typical pasteurization and related additives are unnecessary.

Abstract: Methods are disclosed for increasing the yields of recombinant proteins. Addition of one or more protective agents, such as a sulfated compound (including heparin, heparin sulfate, sodium dodecyl sulfate, and the like), hyaluronic acid or deoxycholate, to recombinant protein production processes is disclosed. Addition of protective agents to the recombinant production process results in increased yields of recombinant proteins.

Abstract: The present invention relates to processes for the purification of proteins. More specifically, methods for solubilizing and purifying proteins expressed in an insoluble form using low concentrations of chaotropic agents, such as guanidine salts, are provided. Also provided are methods for refolding proteins solubilized according to the present invention.

Abstract: A method of a protein assay wherein a protein solution is treated with an acidic component followed by the addition of a precipitate-forming component, which results in precipitation of protein. The protein precipitate is collected and treated with one or more reagents of a protein assay to produce a characteristic protein color reaction. The concentration of protein is determined by measuring the optical density of protein color reaction and comparing the color reaction with a known standard.

Abstract: A method of providing zinc containing crystals of a protein derivative which has a lysine residue which carries a lipophilic substituent on the .epsilon.-amino group, said method comprising providing a solution of the protein derivative in an alkaline buffer, which further contains a zinc salt, adjusting the pH value of the solution to a value between 7 and 10, and isolating the crystals formed.

Abstract: The present invention is a method for the production of a subunit vaccine against canine parvovirus (CPV). The method includes the step wherein a recombinant protein VP2 of CPV is obtained by using the replication of a recombinant baculovirus wherein the gene corresponding to VP2 has been previously inserted in cells of a permissive host. The protein VP2 obtained has the capacity of forming empty VP2 capsids with high immunogenicity and can be provided as a vaccine formulation for protecting dogs against CPV infection the recombinant baculovirus AcMNPV.pCPVEx17 expresses the VP2 of CPV in conditions making possible the formulation of pseudo-viral capsids.

Abstract: The invention relates to new protein derivatives of blood, blood-protein containing raw materials and hemoglobin, and more particularly to processed globin products, and to processes for producing these products. The processed globin products have an isoelectric point at a pH value below 5.5, an iron content of less than 1000 ppm, a ratio of His : Lys between 0.6 and 1.5, a Tyrosine content of at least 0.5% by weight, a Methionine content of at least 0.5% by weight, and a Lysine content of at least 5% by weight. The method for the production of the processed globin products according to the invention comprises treating the starting material at a pH above 12 and an the oxidizing treatment step the pH is kept below 12 while maintaining the temperature below 50.degree. C.

Abstract: A fimbrial agglutinogen preparation is prepared from a bordetella strain, particularly a B. pertussis strain, by a multiple step procedure involving extraction of the fimbrial agglutinogens from cell paste and concentrating and purifying the extracted material. The fimbrial agglutinogen preparation may be used to prepare acellular pertussis vaccines with other pertussis antigens, including pertussis toxin or toxoid thereof, the 69 kDa protein and filamentous hemagglutinin and other Bordetella antigens.

Abstract: The present invention is directed to methods for crystallizing macrophage colony stimulating factor (M-CSF) and to a crystalline M-CSF produced thereby. The present invention is also directed to methods for designing and producing M-CSF agonists and antagonists using information derived from the crystallographic structure of M-CSF. The invention is also directed to methods for screening M-CSF agonists and antagonists. In addition, the present invention is directed to an isolated, purified, soluble and functional M-CSF receptor.

Abstract: The invention relates to chemotactic factors for human spermatozoa that are purifiable from human follicular fluid. The factors are of peptidic and hydrophilic nature and have, one, a molecular size of about 13 kDa and, the other, an apparent molecular size smaller than 1.3 kDa, as determined by high pressure gel filtration. They are for use in procedures related to human fertilization, such as in various types of assisted fertilization, particularly artificial insemination, in vitro fertilization, micromanipulation and direct microinjection of sperm into oocytes.

Abstract: The present invention relates to a purified casein phosphopeptide(CPP) having a novel amino acid sequence and a purified casein including same wherein the 25th Arg from N-terminal in a conventional CPP is replaced by Cys, rendering the CPPs to forming a dimer by disulfide bond. In the corresponding DNA sequence, cytosine is replaced by thymine to cause the amino acid replacement from Arginine(Arg) to Cysteine(Cys). The CPP or the casein containing same has an improved ability of solubilizing minerals and absorbing thereof in animals. The CPP or the beta-casein H containing same can be added to foodstuffs, beverages, medication, cosmetics, feed in an effective amount of enhancing a mineral absorption in animals. An oral composition comprising the beta-casein H or the inventive CPP and a pharmaceutically acceptable carrier can reduce or relieve a dentinal hypersensitivity.

Abstract: A process for the production of essentially homogeneous soluble, stable, endotoxin free human recombinant interleukin-1.alpha. of enhanced specific activity is described. The process involves breaking transformed microbial cells containing expressed human interleukin-1.alpha. and separating the soluble supernatant from the insoluble cell components and then passing the supernatant through gel chromatography and ion-exchange chromatography steps.

Abstract: The present invention relates to the single-chain thrombomodulin ("TM") and analogs thereof that are not susceptible to cleavage by proteases and retain the biological activity of thrombomodulin, as well as methods of use in, for example, antithrombotic therapy. Novel proteins, nucleic acid gene sequences, pharmaceuticals and methods of inhibiting thrombotic activity are disclosed.

Abstract: Virus inactivating chemicals and/or detergents in an aqueous composition containing a water-soluble plasma protein are reduced by selecting a suitable combination of temperature and concentration above 0.5M of salt with a high salting out effect according to the Hofmeister series, thereby forming vesicles containing the virus inactivating chemical and/or detergent. These vesicles are removed from the aqueous phase, e.g. by phase separation or filtration, and the protein thereafter isolated from the aqueous phase. The water-soluble plasma protein can be e.g. antithrombin III, transferrin or albumin. When the aqueous phase comprises e.g. a salt of citrate or sulphate in a concentration above 1M at room temperature, the reduction of virus inactivating chemical or detergent can be as high as 2000 times or more, giving a final concentration below 5 ppm.

Abstract: A composition is provided comprising about 0.1 to 15 mg/ml of a polypeptide in a buffer having a pH of about 7-12 comprising about 5-40% (v/v) of an alcoholic or polar aprotic solvent, about 0.2 to 3M of an alkaline earth, alkali metal, or ammonium salt, about 0.1 to 9M of a chaotropic agent, and about 0.01 to 15 .mu.M of a copper or manganese salt. The buffer is suitably used in a method for refolding improperly folded polypeptides.

Abstract: Disclosed is a method of obtaining a highly soluble protein which method generally includes at least the step of contacting the protein with an amount of antioxidant suitable to raise the solubility of the protein, which method may also be utilized to raise the protein yield of the process. Antioxidants suitable for use in the present invention include substituted and unsubstituted quinones, anisoles, toluenes and tocopherols. Also disclosed is a highly soluble protein which includes a protein and added antioxidant. Further disclosed are food products made from a highly soluble protein. Finally, a method of processing food products is disclosed which at least includes the step of incorporating a highly soluble protein into the food product.

Abstract: There is provided a method for purifying a refold somatotropin monomer from a mixture of somatotropin monomers and somatotropin oligomers in an aqueous solution having a urea concentration of greater than 3 molar by the addition of an acid to reduce the pH of the solution to below about 7.7 to selectively precipitate the oligomers in the most part.

Abstract: Provided is a method for preparing a true, homogeneous solution of a pharmaceutical substance dissolved in an organic solvent in which the pharmaceutical substance is not normally soluble. Solubilization is obtained by forming a hydrophobic ion pair complex involving the pharmaceutical substance and an amphiphilic material. The resulting organic solution may be further processed to prepare pharmaceutical powders. A biodegradable polymer may be co-dissolved with the pharmaceutical substance and the amphiphilic material and may be incorporated into a pharmaceutical powder. A preferred method for preparing pharmaceutical powders is to subject the organic solution to gas antisolvent precipitation using a supercritical gas antisolvent such as carbon dioxide. Also provided is a method for making hollow particles having a fiber-like shape which would provide enhanced retention time in the stomach if ingested by a human or animal host.

Abstract: A composition is provided comprising about 0.1 to 15 mg/mL of a polypeptide in a buffer having a pH of about 7-12 comprising about 5-40% (v/v) of an alcoholic or polar aprotic solvent, about 0.2 to 3M of an alkaline earth, alkali metal, or ammonium salt, about 0.1 to 9M of a chaotropic agent, and about 0.01 to 15 .mu.M of a copper or manganese salt. The buffer is suitably used in a method for refolding improperly folded polypeptides.

Abstract: Methods of isolating components of interest from a milk sample are described. The methods include a step wherein the solubility of at least a portion of the total milk protein is stabilized in such a manner as to allow isolation of the component of interest without significant loss in yield. Kits for stabilizing the solubility of at least a portion of the total milk protein of the milk sample containing the component of interest also are described.

Abstract: A vaccine effective against infection caused by group B Nesseria meningitidis microorganism is provided which comprises a purified protein antigenic complex weighing from 65 to 95 kDa, vesicles, and capsular polysaccharides. This vaccine is extracted from the cell membranes of the live microorganisms using detergent and enzyme. The method of producing an antimeningococcic hyperimmune gammaglobulin and the gammaglobulin produced by the method was provided. The gammaglobulin is obtained from vaccinees vaccinated with the vaccine.

Abstract: A process for manufacturing crystals of growth hormone (GH) comprising the steps of:i) mixing GH with an aqueous solution comprising a buffer and a chemical compound with the general formula (1):Ar--?--CR.sub.1 R.sub.2 --!n--?--C R.sub.3 R.sub.4 --!m--C R.sub.5 R.sub.6 --OH (1)in which Ar is phenyl, alkyl-substituted phenyl, naphthyl, or alkyl-substituted naphthyl, R.sub.1 to R.sub.6 is H, OH or alkyl and n and m is 0 or 1;ii) incubating; andiii) isolating the crystals is provided. The crystals are in the form of needles, trigonal forms, cubes or parallelepipeds with a length of at least 20 microns.

Abstract: A process for the preparation of a recombinant IGF-II (rIGF-II) without a covalently attached foreign protein moiety and without N-terminal attached methionine or a derivative of methionine or of a salt of said IGF-II, rIGF-II produced by said method, hybrid vectors comprising DNA encoding said rIGF-II, hosts transformed with said vectors, and a process for the isolation of said rIGF-II from the host cell and refolding it into a biologically active form.

Abstract: A method for recovering an acylated protein as a powder, especially in cases where said acylated protein is one that resists isolation by isoelectric precipitation from aqueous solutions of the protein, said method comprising in combination adjusting said aqueous solution to near the isoelectric pH of the protein and providing a suitable alcohol concentration to cause precipitation of the protein in the form of filterable particles at said pH.

Abstract: Disclosed is a process to remove tumour necrosis factor .alpha. (TNF.alpha.) or/and bacterial lipopolysaccharides (LPS) from an aqueous liquid, in particular blood, blood plasma or serum, in an extracorporeal perfusion system after removing corpuscular blood components if necessary, wherein(a) the pH value of the body fluid is adjusted to pH<6,(b) a precipitation reagent in the form of a polyanion is added,(c) precipitated substances are removed by filtration or/and centrifugation and(d) the resulting liquid is passed over an anion exchanger.

Abstract: Aglucone isoflavone enriched protein concentrates and processes for producing and recovering are disclosed. The process comprises an isoelectrie wash of a vegetable protein material to provide a protein concentrate, which is slurried and reacted with a sufficient amount of beta-glucosidase enzyme or esterase enzyme for a time period, temperature, and pH sufficient to convert at least a majority of the glucone isoflavones contained in the concentrate to aglucone isoflavones.

Abstract: An improved alcohol-free method for fractionating gluten into gliadin and glutenin fractions is provided where an acidic dispersion of gluten is formed with a reducing agent (e.g., sodium metabisulfite) operable for breaking disulfide bonds in the gluten protein. Thereafter, the pH of the dispersion is raised to cause glutenin to precipitate while leaving gliadin suspended in the dispersion. The respective fractions can then be separated by decanting or centrifugation. In preferred processing, the dispersion is reacidified prior to separation in order to achieve a higher degree of separation of the glutenin and gliadin.

Abstract: A therapeutic composition effective on contact with thrombin at a site of treatment in a patient as a tissue adhesive, hemostat or sealant, said composition comprising non-autologous, non-single donor mammalian fibrinogen that is capable of polymerizing when provided in solution at said site at a concentration of about 30 mg/ml thereof or less, to a fibrin network having therapeutically effective strength, wherein said composition contains less than about 30% (w/w), based on total protein mass present therein, of proteins other than fibrinogen, and further comprises a sufficient amount of one or more low molecular weight physiologically-compatible solutes such that said composition, if formulated as a lyophilized material, can be reconstituted therefrom at room temperature in sterile water for injection in about 30 minutes or less, at about 25 mg/ml of said fibrinogen. Additionally, methods for producing and maintaining said composition, and methods for the use thereof.

Abstract: A method for producing a crystalline zinc interferon (IFN) .alpha.-2 comprising forming a soluble solution of IFN .alpha.-2 and a metal acetate salt under condtions wherein supersaturation and metal alpha interferon crystals occur.

Abstract: A vaccine effective against infection caused by Group B Neisseria meningitidis microorganism is provided which comprises a purified protein antigenic complex weighing from 65 to 95 kDa, vesicles, and capsular polysaccharide. This vaccine is extracted from the cell membranes of the live microorganisms using detergent and enzyme.

Abstract: Serum albumin crystal forms have been produced which exhibit superior x-ray diffraction quality. The crystals are produced from both recombinant and wild-type human serum albumin, canine, and baboon serum albumin and allow the performance of drug-binding studies as well as genetic engineering studies. The crystals are grown from solutions of polyethylene glycol or ammonium sulphate within prescribed limits during growth times from one to several weeks and include the following space groups: P2.sub.1, C2, P1.

Abstract: A cytokine composition is prepared for use in immunotherapy of various diseases. The composition is prepared by culturing leucocytes previously infected with a virus in a culture medium containing a transal composition isolated from plasma and a complex of proteinase inhibitors composition isolated from plasma, separating leucocytes from the medium, removing impurities from the medium, and recovering a cytokine composition containing the transal composition and the complex of protease inhibitors composition. The transal composition contains transferrin, albumin and a 40 kDa protein and the complex of protease inhibitors composition contains .alpha..sub.2 -macroglobulin, a 160 kDa protein, an 80-60 kDa protein and a 20 kDa protein.

Abstract: Highly stable plasma-derived therapeutic albumin solutions, having a turbidity level of 5 NTU or less can be made by adding sodium caprylate to Cohn fraction II+III or IV-1 effluent at relatively low temperatures. The sodium caprylate acts as a partitioning agent to separate albumin from unwanted proteins. In preferred embodiments, the albumin source solution temperature is elevated, increased in pH and reacted for approximately six hours under conditions sufficient to disrupt the initial solution colloid, and partition albumin-containing supernatant from a colloidal disperse phase, which retains unwanted globulins and manufacturing debris. Since it tends to be a scavenger molecule, albumin is selectively stabilized by diafiltration against a buffer containing sodium caprylate, thereby assuring a high albumin monomer content and low turbidity level. The amount of sodium caprylate required for selective stabilization is determined by the amount of available binding sites on the albumin molecule.

Abstract: The present invention is directed to a process for recovering the antibiotics produced by fermentation of Actinoplanes sp. ATCC 33076 or a producing mutant thereof, from a fermentation broth or a process stream, which comprises extraction of the antibiotics by a non-ionic surfactant or a cationic surfactant miscible with or dispersable in water and capable of dissolving the antibiotics, formation of two phases in the first of which the antibiotic and the surfactant are present together, and separation of the antibiotic from the surfactant by addition of suitable organic solvents.

Abstract: A process for the preparation of spherules and emulsions containing such spherules. A primary oil-in-water emulsion is formed containing particles comprising one or more active principles in oily form suspended in water, the water optionally containing at least one protein. Controlled division of the primary emulsion is achieved by combining the primary emulsion with a water-immiscible solvent to create a second emulsion containing spherules of the primary emulsion. Preferably, the particles of the primary emulsion have mean diameters of about 1 .mu.m, and preferably, the spherules contained in the second emulsion have a diameter ranging from 100 .mu.m to 500 .mu.m. If protein is contained in the primary emulsion, the protein can be cross-linked. Further, the spherules can be separated from the water-immiscible solvent.

Abstract: A composition and method for separating red blood cells from whole blood comprising a rouleaux-forming aggregator and an enhancer for enhancing the settling rate. The enhancer is a material which alters directly or indirectly the properties of the red blood cell and may alter the structure and/or reactivity of the aggregator, without adversely affecting the morphology and function of white blood cells. In most instances, the red blood cell enhancers of the invention are osmotic agents. Such agents create a hypertonic solution while not entering the cells themselves. Preferably the enhancer is a salt of oxalic acid, a salt of malonic acid, mannitol or sucrose. Potassium oxalate is most preferred. High molecular weight substances which are large enough to form molecular bridges between red blood cells form the aggregators used in the invention.

Abstract: A method for recovering hepatitis B surface antigen protein from transformed yeast cells including the steps of (i) obtaining an aqueous homogenate of the yeast cells; (ii) enriching the hepatitis B surface antigen protein in the homogenate with a protein-aggregating reagent to form a precipitate which contains hepatitis B surface antigen protein; (iii) dissolving the precipitate in a buffer to form a suspension; and (iv) post-homogenizing the suspension to obtain a 10% to 50% increase in yield of the hepatitis B surface antigen protein as calculated based on a yield achieved without performing the post-homogenizing step.

Abstract: The continuous removal of solid products from a high-pressure system is achieved by operating a high-pressure pump in reverse to gradually reduce pressure at the exit line to atmospheric pressure. This process allows solid products to exit the system while at the same time maintaining high pressure in the reactor.

Abstract: A composition and method for separating red blood cells from whole blood including a rouleaux-forming aggregator and an enhancer for enhancing the settling rate. The enhancer is a material which alters directly or indirectly the properties of the red blood cell and may alter the structure and/or reactivity of the aggregator, without adversely affecting the morphology and function of white blood cells. In most instances, the red blood cell enhancers of the invention are osmotic agents. Such agents create a hypertonic solution while not entering the cells themselves. Preferably the enhancer is a salt of oxalic acid, a salt of malonic acid, mannitol or sucrose. Potassium oxalate is most preferred. High molecular weight substances which are large enough to form molecular bridges between red blood cells form the aggregators used in the invention.

Abstract: The present invention relates to a process of making a concentrate of coagulation proteins starting with whole human or animal plasma. This concentrate is used as a biological adhesive when extemporaneously mixed to thrombin. The concentrated proteins include mostly fibrinogen, fibrin stabilizing factor (factor XIII) and fibronectin. The claimed process has the advantage of being short of execution while providing an excellent yield of coagulable proteins. No protease inhibitor has to be added during the process. The process involves steps of separation by "salting-out" in presence of amino-6 hexanoic acid which prevents co-precipitation of plasminogen with the desired coagulable proteins. The proteins so obtained are very stable after reconstitution in water for at least 24 hours at room or body temperature. After mixing with thrombin and calcium, the adhesive shows excellent strength and biocompatibility.

Abstract: A process for the microbial production of a protein susceptible to inactivation in a fluid production medium by continuously and reversibly protecting said protein against said inactivation during the production stage, separating the protein from the production medium, deprotecting the protein, and recovering the protein product. The process is especially useful for obtaining substantially increased yields of the protein in question by continuously precipitating said protein.

Abstract: Shelf-stable solvent solutions and methods for simultaneously isolating RNA, DNA and proteins from biological samples are disclosed. The solvent solutions include phenol and a guanidinium compound, preferably at a concentration below about 2M, which is effective in isolating substantially pure and undegraded RNA, substantially pure and undegraded DNA, and proteins from the same biological sample.

Abstract: A process for the preparation of an amylase inhibitor is disclosed which comprises the steps of:(a) extracting wheat, wheat flour or wheat gluten with water, a dilute acid, a dilute alkali or an aqueous alcohol to produce a solution containing the amylase inhibitor;(b) adding a polysaccharide to said solution to form an insoluble complex of the amylase inhibitor with the polysaccharide and separating the insoluble complex from the solution;(c) dissolving or dispersing said complex in a solution, then separating the polysaccharide from the solution to collect a solution containing the amylase inhibitor; and(d) treating the collected solution with a cation exchanger to recover the amylase inhibitor from fractions that have not been adsorbed on the cation exchanger.

Abstract: A therapeutic composition effective on contact with thrombin at a site of treatment in a patient as a tissue adhesive, hemostat or sealant, said composition comprising non-autologous, non-single donor mammalian fibrinogen that is capable of polymerizing when provided in solution at said site at a concentration of about 30 mg/ml thereof or less, to a fibrin network having therapeutically effective strength, wherein said composition contains less than about 30% (w/w), based on total protein mass present therein, of proteins other than fibrinogen, and further comprises a sufficient amount of one or more low molecular weight physiologically-compatible solutes such that said composition, if formulated as a lyophilized material, can be reconstituted therefrom at room temperature in sterile water for injection in about 30 minutes or less, at about 25 mg/ml of said fibrinogen. Additionally, methods for producing and maintaining said composition, and methods for the use thereof.

Abstract: The invention concerns a process for purifying protein A preparations to high purity with high product yield. Where the protein A is obtained from a Gram-negative recombinant microbe hosting a vehicle containing a gene encoding protein A, the protein A is purified to high purity, and, advantageously, to very low levels of endotoxin. The protein A preparations made via the invention process are useful in therapeutic application, e.g., therapeutic plasma exchange, as well as for other well-known uses of protein A.

Abstract: A composition is disclosed which comprises a solution of human serum albumin essentially free of chemicals used in processing. The preparation is also essentially free of metals such as aluminum. The composition is 100% pure by cellulose acetate electrophoresis and is essentially monomeric when tested by high pressure liquid chromatography. The turbidity is less than 5 N.T.U. (National Turbidity Units). This preparation has a substantially longer shelf life and remains biologically active longer than products currently available. The novelty of this product is also such that it does not leach metallic substances such as aluminum from its closure. Novel applications of process methodology are taught in the preparation of this composition and a novel preparation results from essentially non hemoglobin containing albumin sources such as Source Plasma (Human).