Abstract: Human serum albumin obtained by gene manipulation techniques can be purified by a combination of specified steps in which a culture supernatant obtained from a human serum albumin-producing host is subjected to ultrafiltration, heat treatment, acid treatment and another ultrafiltration, followed by subsequent treatments with a cation exchanger, a hydrophobic chromatography carrier and an anion exchanger, and by salting-out to thereby obtain a pure form of human serum albumin which contains substantially no proteinous and polysaccharide contaminants, which is formulated into a pharmaceutical preparation. The thus obtained human serum albumin can further be purified by treating recombinant human serum albumin with a hydrophobic chromatography carrier at pH of 2 to 5 and a salt concentration of 0.4 to 1 and exposing the carrier to a pH of 6 to 8 and a salt concentration of 0.01 to 0.

Abstract: Tumor Necrosis Factor Binding Proteins (TBPs) are useful in the treatment of autoimmune diseases and graft-versus-host reactions.

Abstract: Isolated complexes (which include basement membrane components), antibodies to such complexes or polypeptide constituents thereof, and methods for detecting such complexes or constituents are disclosed. Detection of such complexes in a biological sample by immunological and non-immunological methods allows the diagnosis of a variety of diseases, including cancers, collagen degenerative diseases, and hepatitis. Suitable biological samples include urine, cervical secretions, bronchial aspirates, sputum, saliva, feces, serum, synovial fluid, and cerebrospinal fluid.

Abstract: A self-supporting composite bioactive material and method of making it, which comprises immersing a body of collagen in a solution comprising a calcium phosphate and a phosphoprotein (preferably containing o-phosphoserine residues) to deposit on the collagen a mineralized layer of calcium phosphate and the phosphoprotein.

Abstract: Described is an improved process for fragmenting a biomaterial and isolating and recovering a component thereof. The preferred improved process includes the step of performing the fragmentation by nebulizing a liquid medium containing the biomaterial. A preferred process for fragmenting isolated DNA includes the step of nebulizing a fluid containing the DNA. This preferred process provides randomness superior to prior known DNA fragmentation methods, as well as other important advantages. Improved nebulization devices are also described.

Abstract: It has been discovered that it is possible to administer truncated tissue factor, not having the transmembrane region (tTF) in combination with factor VIIa (FVIIa) to treat bleeding disorders such as those resulting from hemophilia or cirrhosis of the liver. Preferably, the tTF is administered to produce up to 10 .mu.g tTF/ml of plasma. The FVIIa is administered to produce levels of between 40 ng FVIIa/ml and 4 .mu.g FVIIa/ml of plasma. The effective dosages of both tTF and FVIIa are significantly and surprisingly less than the administration of either alone to stop bleeding. Examples demonstrate safety and efficacy in normal and hemophilic dogs.

Abstract: It has been discovered that it is possible to administer truncated tissue factor (not having the transmembrane region) (tTF) in combination with factor VIIa (FVIIa) or an activator of endogenous factor VII to treat bleeding disorders such as those resulting from hemophilia or cirrhosis of the liver. The tTF is administered to produce up to 10 .mu.g tTF/ml of plasma. The FVIIa or FVII activator is administered to produce levels of between 40 ng FVIIa/ml and 700 ng FVIIa/ml of plasma. The effective dosages of both tTF and FVIIa/factor VII activator are significantly and surprisingly less than the administration of either alone to stop bleeding. Examples demonstrate safety and efficacy in normal and hemophilic dogs.

Abstract: The present invention concerns a process for the production of well-tolerated, preserved injection or infusion solutions containing human protein.

Abstract: Enteral nutritional composition comprising 4-30% lipid component, 65-80% carbohydrate component and 16-25% protein component, based on total caloric content, wherein said protein comprises by weight 14-30% glutamine and 5-33% arginine and said composition has a nonprotein calorie to grams of nitrogen ratio of 150:1 to 80:1.

Abstract: The invention relates to a process for deactivating the inner surfaces of capillaries for capillary zone electrophoresis and capillary gel electrophoresis. The deactivation is effected by coating the inner surface with polar polymers which initially are water-soluble, whereupon the polymers are subsequently thermally fixed by a formation of water-insoluble polymers. The invention further relates to the capillaries thus produced and to the use thereof for the separation of oligonucleotides, peptides and proteins.

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: 5(6)-methyl substituted fluorescein derivatives and a process for producing 5(6)-methyl substituted derivatives. Also provided are methods for these utilizing these derivatives as indicator reagents in assays for analytes, indicator reagents which comprise specific binding members attached to these derivatives and test kits which contain these derivatives.

Abstract: The present invention provides methods of preventing or treating conditions associated with burn injuries by administering bactericidal/permeability-increasing (BPI) protein product.

Abstract: It has been determined that estrogen and other hormones elevated in pregnancy induce a specific modulation of lymphocyte precursor cell production. The immune system of an animal or bone marrow cells in culture can therefore be modulated in a specific manner by administration of hormones elevated during pregnancy, such as estrogen and estrogen-like compounds or compounds that interfere with the synthesis or activity of these hormones, to increase or decrease production of B lymphocyte precursor cells.

Abstract: Patients with chronic liver disease and consequently very low concentrations of IGF-1 in the blood, in spite of increased GH concentrations, are treated with periodically injections of hGH for a period both parameters being individually adjusted for the patients.

Abstract: The present invention provides a biomarker system for the in vivo and in vitro assessment of cell senescence. In the method of the present invention, .beta.-galactosidase activity is utilized as a means by which cell senescence may be assessed either in in vitro cell cultures or in vivo.

Abstract: A macromolecular microparticle composition formed by dehydrating an aqueous macromolecule solution and crosslinking the dehydrated macromolecules with a crosslinking agent while in a liquid phase or with heat. Preferably, the dehydrating agent is a polymer mixture of polyvinylpyrrolidone and polyethylene glycol, the crosslinking reagent is glutaraldehyde, and the macromolecule is a protein, most preferably an immunoglobulin. Methods of use for research, diagnostics and therapeutics are also provided.

Abstract: Gelatin, having high Bloom or gel strength in excess of 300, is extracted from fish, with high yield, by pre-treating collagen rich fish skins with a limewater (Ca(OH).sub.2) solution suspension with a concentration of between 19 gm of Ca(OH).sub.2 /liter of water/kg of tilapia fish skin to 100 gm Ca(OH).sub.2 /liter of water/kg of fish skin for a period of time between ten to sixty days and optimally between two to four weeks. For fish with higher percentage of fat content, a minimum concentration is at least 50 gm of Ca(OH).sub.2 /liter of water/kg of fish skin to avoid putrefaction. For fish with easily extractable gelatin, such as Nile perch, soaking time is from 3 to 10 days with a concentration of Ca(OH).sub.2 /liter of water of about 15 gm. At concentrations above 100 gm of Ca(OH).sub.2 /liter of water/kg of fish skin and/or treatment time periods in excess of four weeks, Bloom strength dramatically decreases.

Abstract: An improved kinetic assay is provided for spectrophotometrically determining the dissolved carbon dioxide (CO.sub.2) content of a body fluid (e.g., blood, plasma or serum), wherein at about pH 8.0 the CO.sub.2 is present substantially as bicarbonate ion (HCO.sub.3.sup.-). The assay sample is first subjected to a coupled reaction mixture containing phosphoenolpyruvate (PEP) and phospho-enolpyruvate carboxylase (PEPC) which enzymatically catalyzes conversion of HCO.sub.3.sup.- to oxaloacetate (OA). The OA produced is subjected to a second coupled reaction mixture containing nicotinamide adenine dinucleotide (NADH) and malate dehydrogenase (MDH) which thereby reduces the OA to malate and oxidizes the NADH to AND.sup.+. The CO.sub.2 level in the body fluid sample may indirectly be determined by spectrophotometrically measuring the change in NADH concentration.

Abstract: A method and apparatus for determining the enzyme or enzymes in the human body which metabolize a particular drug. Microsomes are obtained from each of several donors. The microsome for one donor is reacted with a test drug and the quantity of metabolites produced is determined. The microsomes are similarly each reacted with the test drug and the quantity of metabolites produced for each microsome is determined to generate drug metabolism data. The drug metabolism data obtained is compared to reference data which indicates the activity of a select number of major enzymes in each of the donors. The reference data for each enzyme is separately tabulated. The enzyme responsible for the metabolism of the test drug is identified when the metabolism data correlates with the tabulated reference data for that enzyme.