Abstract: Describes IgA binding protein isolatable from Group B streptococci, methods of isolation and use in immunological testing procedures.

Abstract: The invention provides a process for the insulation of an antigenic composition substantially free from cells and lipopolysaccharide, the said composition comprising a complex having a polysaccharide constituent and a protein constituent, wherein the polysaccharide constituent comprises capsular polysaccharide specific to serogroup B of N. meningitidis, and the protein constituent comprises N. meningitidis outer-membrane protein selected from the class consisting of those proteins specific to serotype 6, those proteins specific to serotype 2 and having a single dominant component having a molecular weight of 42,000.+-.3,000, and immunological equivalents of such proteins. Preferably the composition also comprises a pharmacologically acceptable metal either as an adjuvant in admixture with the polysaccharide-protein complex, or in complex therewith to provide a triple metal-polysaccharide-protein complex. The composition is useful for the prophylaxis or treatment of bacterial disease in mammals such as man.

Abstract: A refractile material containing a heterologous protein is recovered from a host microorganism cell culture transformed to produce the protein. One recovery process involves disrupting the cell wall and membrane of the host cell, removing greater than 99% by weight of the salts from the disruptate, redisrupting the desalted disruptate, adding a material to the disruptate to create a density or viscosity gradient in the liquid within the disruptate, and separating the refractile material from the cellular debris by high-speed centrifugation. Another version of such a recovery process comprises the further steps of solubilizing the refractile material under reducing conditions, organically extracting the solubilized refractile material, and isolating said refractile material from the extractant.Preferably the protein is recombinant IL-2 or IFN-.beta. and the salt removal step is carried out by diafiltration.

Abstract: A vaccine effective in protecting mammals against urinary infections is prepared from purified Gal-Gal pilus proteins or fragments thereof.

Abstract: The group B polysaccharide of Neisseria meningitidis is chemically modified to enhance the immune response thereto, thereby providing cross-reactive antibodies of high affinity. The N-acetyl group of the sialic acid residues of the polysaccharide has been substituted by the N-propionyl group, and this modified antigen then conjugated to a physiologically-acceptable protein such as tetanus toxoid. This conjugate vaccine has been found to raise high titers of high affinity group B IgG antibodies and would be useful against meningitis caused by group B N. meningitidis or by E. coli KI organisms.

Abstract: Recombinant plasmids are constructed by inserting a DNA fragment containing the env gene of adult T cell leukemia virus or a part thereof into a vector DNA. Microorganisms are transformed with the recombinant plasmid and thereafter cultured to express the peptide. The antigen polypeptide encoded by the env gene is useful for the detection and diagnosis of adult T cell leukemia.

Abstract: Recombinant E. coli clones which cell surface-express Legionella pneumophila antigens, a method for utilizing these clones for the detection of Legionella antibodies in a clinical sample, and a method for isolation of mono-specific anti-Legionella antibodies are disclosed. The recombinant clones are produced by ligating fragmented Legionella DNA to pBR322 which is then used to transform the appropriate E. coli host. Clones that cell surface-express individual Legionella antigens are selected by screening cellularly intact clones using anti-Legionella antibodies to probe for cell surface expression. An enzyme-linked immunosorbant assay (ELISA) is disclosed which utilizes the Legionella antigen-expressing clones to detect anti-Legionella antibodies.

Abstract: Compositions containing therapeutically or immunologically active proteins are rendered substantially free from infectious agents such as viable viruses and bacteria without substantial loss of therapeutic or immunologic activity by mixing the protein composition with a complex formed from transition metal ions, such as copper ions, and an angularly-fused, polynuclear heterocyclic arene having two nitrogen atoms in a "cis-ortho" relationship, such as phenanthroline, and a reducing agent such as a thiol or ascorbic acid or ascorbate salt or mixtures of ascorbic acid or ascorbate with a thiol in amounts and at a temperature and for a time sufficient to inactivate substantially all of the viruses and bacteria contained therein. Compositions containing therapeutically active proteins substantially free from viral and bacterial infectivity, which have heretofore been unattainable, can be prepared by the method of the invention.

Abstract: Process for preparing a detoxified polysaccharide-outer membrane protein complex from bacterial envelopes; the so-obtained products which are useful as vaccines against infection by the same bacteria and method for protecting animals against the same infection by administration of a pharmaceutical composition containing the detoxified polysaccharide-outer membrane protein complexes.

Abstract: This invention discloses a process for preparing an acellular Bordetella pertussis vaccine by passing culture supernatants or cellular extracts of B. pertussis through a column containing an ion exchange resin. The eluate from the column is detoxified and can then be employed by conventional means as a vaccine. The vaccine so produced has reduced toxicity due to the removal of endotoxin.

Abstract: Monomeric, biologically active growth hormone is isolated from microbially-produced insoluble inclusion bodies by solubilizing and denaturing the growth hormone by extraction of the inclusion bodies into a guanidine salt solution such as guanidine hydrochloride and subsequently renaturing at least a portion of the growth hormone in the solution by replacing the guanidine salt solution with a denaturant-free buffer solution and removing precipitated impurities and growth hormone aggregates. The renatured growth hromone is then purified by ion-exchange chromatography.

Abstract: Unusually strong binding of IgG to protein A is achieved by contacting these components in the presence of a medium containing a high concentration of salt. Although such binding is of general utility, a particularly useful application is the purification of monoclonal antibodies from ascites fluid by affinity chromatography.

Abstract: A method for obtaining bacterium pili subunits directly from specified bacteria is disclosed and claimed. Dependent upon the bacterium from which the pili subunits are to be obtained, the pH of extraction solutions will be adjusted accordingly. Pili subunits obtained in accord with the method of this invention are useful for preparing vaccines which exhibit good protection against heterologous strain infections.

Abstract: PSC-A is a new serological common antigen to Pseudomonas aeruginosa having very low toxicity, and highly effective for protecting infection by any of the serotypes of Pseudomonas aeruginosa. PSC-A can be used as the active component in a pharmaceutical agent for protecting Pseudonomas aeruginosa infection.

Abstract: A process for preparing nucleoproteic material which comprises immersing organic material into a suitable solvent for a sufficient time to extract nucleoproteins from said material, adding a sufficient amount of an acid to form a precipitate of nucleoproteic material, and recovering said nucleoproteic material precipitate. A composition of nucleoproteic material produced according to this process. A method for alleviating symptoms of neoplastic diseases which comprises sterilizing the composition of nucleoproteic material, preparing a formulation comprising an effective amount of said sterilized composition, and administering said formulation to a patient having symptoms of a neoplastic disease.

Abstract: There are provided a crystalline and single rod products derivable from the Pili of Type 1 and Type 2 Neisseria gonorrhoese organisms. There are provided methods of growing said organisms to produce the maximum yield of Pili and procedures for purifying said Pili to produce said crystalline material. There are further provided methods of utilizing said Pili to determine the presence, in a system infectable by N. gonorrhoese organisms, of antibodies to the Pili of said organisms, and methods of serotyping said Pili. There is also provided a mode of utilizing said crystalline material to provide a substantial degree of immunization infection by N. gonorrhoese in mammalian systems susceptible to such infection.

Abstract: A method for solubilization and naturation of somatotropin protein from refractile bodies of host cells is disclosed. The method embraces the discovery that an aqueous solution of urea, or dimethylsulfone, or mixtures of urea and dimethylsulfone, can be effectively used to solubilize refractile bodies containing such somatotropin protein. Once solubilized, somatotropin protein can be natured in an aqueous solution of urea, or dimethylsulfone, or mixtures of urea and dimethylsulfone, by contacting the solution with a mild oxidizing agent for a time sufficient to result in the formation of the disulfide bonds. Naturation can efficiently occur even at high protein concentration, in an impure preparation and in the absence of reducing agent.

Abstract: The major iron-regulated protein of a pathogenic species of the genus Neisseria, the gonococcal congener of which (MIRP) protein has a molecular weight of approximately 37,000 daltons and consisting of about 340 amino acids, is isolated in an immunospecific antigenically substantially pure form suitable for use as a vaccine against the pathogenic species of the genus Neisseria effective to stimulate the production of a protective level of antibodies to the pathogenic species in a susceptible host, by the steps of:growing cells of that pathogenic species in an iron-depleted bacteriologic media;harvesting the thus-grown cells;disrupting the cells;separating the soluble portion of the cells from the insoluble portion; andselectivity solubilizing the MIRP from the insoluble portion of the disrupted cells with an aqueous cationic surfactant aqueous media, e.g., cetyltrimethylammonium bromide; andremoving residual contaminates in the MIRP fraction by chromatographic fractionation.

Abstract: Bifunctional derivatives of a 3-carboxhydrazide of an antineoplastic dimeric indole-dihydroindole alkaloids, useful both in forming conjugates with immunoglobulins and as anti-tumor agents.

Abstract: Dehydrated protein materials are treated with gaseous HCl without temperature control, the reaction temperature being susceptible to reach, momentarily, 150.degree. C. Then the material thus treated is degassed and, after drying, a non hygroscopic powder usable in the food industry or in the pharmaceutical industry is obtained.

Abstract: A novel non-allelic human growth hormone variant protein is disclosed. The structure of the protein is determined and the protein product is produced by recombinant DNA methods.

Abstract: A pharmaceutical composition comprising a purified pyridine-soluble extract of a microorganism and a refined detoxified endotoxin which is effective in producing an immunological response in warm blooded animals and humans. Methods of using the composition for these purposes are also disclosed.

Abstract: The present invention relates to a process for the production of virus vaccine, comprising covalently attaching virus to saccharide to form a virus-saccharide conjugate, and harvesting the resultant conjugate. The virus vaccine, prepared according to the present invention, exhibits a higher producibility of immunoglobulin G and immunoglobulin M antibodies, while it induces less or substantially no production of immunoglobulin E antibody, in comparison with conventional-type inactivated virus vaccine; thus, the present vaccine is favorably usable for the prevention and treatment of viral diseases.

Abstract: This invention discloses a novel process for the solubilization, purification and characterization of a protein or proteins from insoluble protein aggregates or complexes. The novel process comprises the use of a dissociating step gradient which can be followed by further purification and concentration. Also disclosed are compositions of matter and vaccines comprising one or more proteins purified according to the novel process of this invention.

Abstract: An improved process is described for recovering proteins from insoluble inclusion bodies produced in transformant microorganisms. Sidestream precipitates isolated from chromatography effluent are resolubilized in a denaturing agent and the resolubilized proteins are renatured either by direct dialysis into denaturant-free buffer or by dialysis into a weaker denaturing agent followed by dialysis into denaturant-free buffer.

Abstract: This invention relates to an antitumor composition of anthracycline compounds bonded to hydrophilic polypeptides having a molecular weight between 10,000 and 15,000.

Abstract: Disclosed herein is a novel collagenase "discolysin". It is useful for biochemical researches and the treatment of many diseases caused by collagen, such as hernia of intervertebral disc. It can be produced by culturing a discolysin-producing bacterium belonging to genus of Streptomyces in a culture medium and then collecting discolysin from the culture medium.

Abstract: Inactivated staphylococcal alpha toxin which is in a detoxified immunogenically active form prepared as a vaccine and administered parenterally to patients having multiple sclerosis or other disease involving demyelination of nerve sheath myelin. The amount of the inactivated alpha toxin administered is sufficient to effectively immunize the patient against active staphylococcal alpha toxin. The patient becomes subsequently infected with staphylococcus, the alpha toxin resulting from the infection is neutralized by the alpha toxin binding antibodies. This prevents exacerbation of the demyelination of the nerve sheaths, which otherwise can be promoted by the alpha toxin resulting from the staphylococcus infection.

Abstract: This specification describes a process for separating impurities from an impure mixture containing proinsulin-like material with substantially complete recovery of said proinsulin-like material, which comprises:(1) applying said mixture to a reverse phase macroporous acrylate ester copolymer resin support at a pH of from about 7 to about 10; and(2) eluting said proinsulin-like material from said support with an aqueous eluant having a pH of from about 8 to about 11 and containing from about 10% to about 30% by volume of an organic diluent selected from the group consisting of acetone, acetonitrile, and a combination of acetone and acetonitrile.

Abstract: Products which are soluble without opalescence even at pH 3 and which, because of their reproducible composition, are particularly well suited as a source of nitrogen for organisms are obtained by enzymatic degradation of uniform microbial cell aggregates, using endoproteases, and isolation of the protein fraction up to 2,000 Dalton, preferably from 400 to 1,500 Dalton.

Abstract: This specification describes a process for separating impurities from an impure mixture containing growth hormone-like material with substantially complete recovery of said growth hormone-like material, which comprises:(1) applying said mixture to a reverse phase macroporous acrylate ester copolymer resin support at a pH of from about 7 to about 9; and(2) eluting said growth hormone-like material from said support with an aqueous eluant having a pH of from about 7 to about 9 and containing from about 20% to about 80% by volume of an organic diluent selected from the group consisting of acetone, acetonitrile, and a combination of acetone and acetonitrile.

Abstract: The present invention relates to biologically active substances obtained by reacting Islets-Activating Protein having an insulin secretion promoting action with a carbonyl compound in the presence of a reducing agent; to anti-diabetic composition in dosage unit form comprising the substance of the present invention; to pertussis vaccine in dosage unit form comprising the substance of the present invention; and to a process for the preparation of the same. The substances of the present invention are suppressed in leukocytosis-promoting effect.

Abstract: A heterologous expression product in host cells is separated from the host cell material by suspending the material in a buffered solution, disrupting the cells and separating the product as refractile material. The refractile material can be dissolved in a strongly denaturing solution, which is then weakened while keeping the protein in solution, thereby allowing unfolding and refolding of the protein.

Abstract: Novel water-soluble, immunostimulating glycoproteins extracted from Klebsiella pneumoniae containing 30 to 45% by weight of proteins, 30 to 40% by weight of neutral saccharides, up to 4% by weight of glucuronic acid, 2 to 5% by weight of osamines and having a molecular weight of about 350,000 daltons.

Abstract: An antigenic material having a molecular weight of 3800-4500, and useful in the preparation of an anticaries vaccine is produced from a known antigenic material, antigen I/II of molecular weight 185,000 daltons obtained from the culture supernatant of Streptococcus mutans. The smaller molecular weight fraction of the invention contains the same antigenic determinants as the known 185,000 dalton material but the lower molecular weight material can be used with less side effects. The antigenic material can be used for the production of vaccine preparations that could be administered parenterally or by topical application to the gums.