Abstract: Mild heat-treatment of IgM antibody concentrates diminishes the potential to induce non-specific complement activation without significant loss of normal immunologic effector functions. These IgM immunoglobulin concentrates retain specific antigen binding properties and activate complement specific antigen binding properties and activate complement when bound to antigen. Preferred product includes at least 20% by weight IgM in an IgM/IgG antibody mixture. Heating is done at a temperature within the range of about 40.degree. C. to 62 .degree. C., preferably about 45.degree. to 55.degree. C., in a solution having an acid pH (preferably 4.0 to 5.0) for at least about 10 minutes.

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).

Abstract: Platelet concentrate containing less then 10.sup.6 white blood cells and prepared from a unit of whole blood sample in a closed multiple blood bag system within less than about eight hours after the whole blood is removed from a human. The concentrate is contained in a platelet storage bag made from polyvinyl chloride plasticized with either trioctyltrimellitate or ethylene vinyl acetate.

Abstract: Nikkomycin compounds have been found to be orally or parenterally effective as anti-fungals in animals. They may be used alone or, preferably, in combination with azole antimycotics for a synergistic anti-fungal effect.

Abstract: A disposable phlebotomist protector device for enclosing a used needle assembly. The device includes a pair of housing elements each having an end portion and an integral elongate portion. At least one end portion has cannula inset elements for retaining the cannula of a needle assembly when the two housing elements are in an open position relative to each other. The housing elements include locking elements designed to engage the two housing elements to form a closed housing that encloses the needle assembly. One end of the housing includes an aperture when in the closed position for inserting a sample tube that engages with the needle assembly. After the used needle is inserted, the device is closed and secured and sampling completed, the device with the enclosed needle can be disposed.

Abstract: Highly purified antihemophilic factor can be produced from a cryoprecipitate by a process comprising a PEG precipitation step, a viral inactivation step and a gel filtration step, all steps being carried out at room temperature.

Abstract: Antibodies, including monoclonal antibodies (Mabs), can be made substantially free of infectious viruses by storing them in a liquid state at conditions of pH, temperature and time sufficient to inactive substantially all infectious viruses. Preferred inactivation methods involve use of a pH equal to or less than about 4.0 at a temperature of at least about 5.degree. C. for at least about 16 hours.

Abstract: An essentially pure and stablized antibody preparation comprising IgM antibodies having a purity greater than about 98% by weight and a nucleic acid content of less than about 200 pg per mg IgM. In one embodiment IgM antibodies from a monoclonal source are subjected to ion exchange and size exclusion chromatography at an alkaline pH to yield a purified IgM having a nucleic acid content of less than 10 pg/mg IgM, preferably less than about 4 pg/mg IgM. A highly purified and stabilized preparation of anti Pseudomonas aeruginosa antibodies is disclosed. The removal of nucleic acids is assured by subjecting the antibody source to at least one and preferably two low pH precipitation steps. In a very preferred embodiment, ion exchange and/or size exclusion chromatography is used to remove any residual nucleic acids.

Abstract: Plastic blood bag system including a bag having a generally longitudinal seal extending from the top of the bag and between two blood bag ports downwardly to at least the lower half of the bag but not to the bottom of the bag, thereby leaving the sole passageway within the bag and between two ports located in the lower half of the bag.

Abstract: An immunoassay for cellular proteins which may be present as contaminants in a product purified from mammalian cell culture. Since mammalian cell culture requires the use of protein-containing media, the assay must be specific in recognizing cellular proteins but not media proteins. This is accomplished by selective adsorption of an antiserum to cellular proteins against media proteins. Quantification of the assay may be improved through the use of a purified antigen, namely fibronectin, which is known to be highly immunogenic.

Abstract: The nikkomycin compound possessing antimycotic activity and having the following structure: ##STR1##

Abstract: A method for evaluating the potential immunogenicity of a protein derived from recombinant DNA technology. The method involves injecting an animal with the recombinant protein and then isolating antiserum from the animal. The antiserum is depleted of antibodies to a reference protein, i.e., a plasma derived protein, by adsorbing the antiserum against the reference protein. The adsorbed antiserum is then blotted against the recombinant protein, to see if any antibodies were produced which recognize the recombinant protein, but did not recognize the plasma-derived protein during adsorption.

Abstract: Nikkomycin compounds have been found to be orally or parenterally effective as anti-fungals in animals. They may be used alone or, preferably, in combination with azole antimycotics for a synergistic anti-fungal effect.

Abstract: Antibody preparation purified using immobilized protein A and yet substantially free of protein A that may have solubilized during the purificaiton process. The antibodies include less than 15 ng protein A per mg of antibody, preferably less than 1 ng/mg. Low protein A content is obtained by first contacting the antibodies and solubilized protein A with an ion exchange resin under conditions to adsorb both. The antibodies and protein A are then sequentially eluted under conditions of increasing ionic strength.

Abstract: A source for antibodies (both IgG and IgM types) is put into an aqueous solution which includes a virucidal agent under conditions sufficient to assure substantially complete dissolution of both the antibodies and the virucidal agent and virus inactivation. Then the pH, conductivity and antibody concentration of the solution are then changed to obtain conditions sufficient to assure the precipitation of substantially all antibodies while maintaining substantially all of the virucidal agent in the supernatant solution.In preferred embodiments, using a TNBP/TWEEN virucidal agent, the original solution conductivity ranges from about 0.03 to 0.20 M MHO/CM, the pH ranges from about 4.75 to 4.85, and the protein concentration, when measured at A280, ranges from a reading of about 5 to 40. In the second precipitation step, the pH is changed to a range of about 6.0 to 7.5 and the conductivity is changed to a range of about 0.05 to 0.

Abstract: Method of purifying a protein from a solution of substances comprising the steps of passing the solution through an ion exchange material at a pH which facilitates binding of the protein of interest, washing the bound protein at a different pH at which the bound protein does not elute but which the free protein would not bind to the ion exchange material, and then eluting the protein at a pH which facilitates elution. Method is especially useful in purification of antibodies such as antibodies to tumor necrosis factor.

Abstract: A method of preparing neocytes and gerocytes in a closed blood bag system useful for the filtration of leukocytes from a red blood cell concentrate followed by the preparation and long term storage of neocytes and, preferably, gerocytes from the filtered concentrate. In very preferred embodiments, the system also provides containers for the expression of plasma and the preparation and long term storage of platelets.