Other

Beckman Instruments, Inc.

Plasma Technologies, LLC

Baxter Laboratories, Inc.

Allan L Louderback

Paul R Szatkowski

Dennis Curtin

Anthony J Fontana

Gene Zurlo

Eugene J Zurlo

Robert A Huddy

Thomas J Foley

The instant invention provides novel and effective methods of isolating alpha-1-antitrypsin from cryo-poor plasma and formulating it into therapeutic products. This invention achieves higher yields and a superior quality of alpha-1-antitrypsin. Alpha-1-antitrypsin is isolated from cryo-poor plasma, using one or more salts selected from a group comprising sodium citrate, sodium acetate, sodium gluconate, ammonium sulfate, sodium chloride, sodium sulfate and ammonium chloride in two fractionation steps, followed by diafiltration to remove those salts employed.

Ultra-high yield of alpha-1-anti-trypsin

An efficacious large-scale alcohol-free plasma fractionation production process which produces a high-yielding, non-denatured, double viral-inactivated intravenous human immune gamma globulin (IgG) product. The process employs sodium citrate in two initial fractionation steps, followed by diafiltration to remove sodium citrate.

Ultra-high yield intravenous immune globulin preparation

An efficacious large-scale alcohol-free plasma fractionation production process which produces a high-yielding, non-denatured, double viral-inactivated intravenous human immune gamma globulin (IgG) product. The process employs one or more salts from a group of salts comprising sodium citrate, sodium acetate, sodium gluconate, ammonium sulfate, sodium chloride, sodium sulfate and ammonium chloride in two initial fractionation steps, followed by diafiltration to remove those salts employed. A process which employs alcohol via the process of the disclosed inventive method is also disclosed.

A process for making Solvent Detergent (SD) treatment effective against non-enveloped viruses. The process stipulates using prequalified concentrations of formaldehyde and phenol with SD treatments. In particular, serial or combined use of 100 to 10,000 parts per million of formaldehyde and/or 100 to 10,000 parts per million of phenol with an associated SD treatment process are disclosed.

Augmented solvent/detergent method for inactivating enveloped and non-enveloped viruses

A screening test for bacterial vaginosis is performed by (a) combining a sample of vaginal fluid with a developer reagent selected from the group consisting of phenol, derivatives thereof, and mixtures thereof to form a first reaction medium; (b) combining the first reaction medium with a water soluble base and a halogen-containing oxidizing agent to form a second reaction medium having a pH of at least about 9.5; and (c) observing the color of the second reaction medium. The concentration of the halogen-containing oxidizing agent in the second reaction medium is about 0.12 or greater (on a molar basis) than the concentration of the developer reagent in the second reaction medium. The foregoing procedure can be used to test for the presence of amines in any aqueous fluid as well as for synthesizing various dyes.

Bacterial vaginosis screening technique and a diagnostic kit for use therein

A method of removing virus from white blood cells without causing concurrent damage to any red blood cells is provided by treating the white blood cells with an effective amount of a special detergent which selectively lyses the white blood cells without causing substantial lysis of any red blood cells in admixture therewith.

Method of treating white blood cells

HTLV-III virus in blood or blood components is inactivated by treatment with about 0.1-5% of phenol, formaldehyde, or mixtures thereof, at a temperature of about 2.degree.-40.degree. C. for at least about 5 minutes.

Method of inactivating HTLV-III virus in blood

A stable control solution is provided for the determination of urobilinogen. The control solution comprises an aqueous solution of about 3-12% ethylene glycol, about 0.1% protein and preferably about 40-400 mg/dl urobilinogen, said composition buffered to pH about 8.0-9.0 and retained in a hermetically sealed container under a blanket of inert gas.

Urobilinogen control

An improved composition of the type comprising a known concentration of at least one enzyme. The composition is characterized in that substantially all of at least one of the enzymes is combined with a stabilizing amount of a reversible inhibitor thereof to form an inhibitor-enzyme complex, thereby stabilizing the enzyme moiety of the complex. A method of stabilizing a composition comprising a known concentration of at least one enzyme. The method comprising combining substantially all of at least one of the enzymes with a stabilizing amount of a reversible inhibitor thereof to form an inhibitor-enzyme complex, thereby stabilizing the enzyme moiety of the complex.

Stabilized enzymatic composition

A hematology control is disclosed which is useful for clinical hematology procedures and, in particular, mean corpuscular volume (MCV) determinations. The hematology control comprises an aqueous suspension of red blood cells in which varying levels of MCV are provided by applying to the red cell component, after light treatment with aldehyde, an osmotic pressure that is directly proportional to the desired red blood cell size.

Hematology control

A stable blood serum conjugated bilirubin reference composition characterized in that the composition possess a pH of from about 8.2 to bout 9.2 and comprises (a) a sulfhydryl compound in an amount sufficient to enhance the stability of the conjugated bilirubin and (b) a chelating agent in an amount sufficient to bind all the metals present in the blood serum moiety of the composition. This blood serum conjugated bilirubin composition when stored in a gas impervious vial under an inert atmosphere has an excellent shelf life.

Method for increasing shelf-life of a serum conjugated bilirubin

A stable enzyme reference composition having an excellent shelf-life. The composition comprises at least one enzyme of known value; about 20 to about 40 weight percent of at least one alkylene polyol having from 2 to 5 carbon atoms; about 3 to about 8 grams (gm) per deciliter (dl) total protein present in a human serum albumin matrix; and about 60 to about 80 weight percent water.

Enzyme reference composition

A blood biochemistry control standard for the quality control of the analytical measurement of blood biochemistry components is disclosed. The control standard comprises an aqueous suspension of red blood cells which have been stabilized by mild treatment with aldehyde and saline and then slowly equilibrated with at least one additionally incorporated non-gaseous biochemical analyte in a concentration of clinical significance.

Blood biochemistry control standard

An improved blood serum reference composition of the type comprising blood serum having constituents of known values, characterized in that said composition further comprises a water soluble amine chloride. The water soluble amine chloride is employed to adjust the negative electrolyte balance of said reference composition without interfering with presently employed blood serum clinical assay procedures or analytical equipment used therein.

Growing community of inventors

Temple City, CA, United States of America

Allan L Louderback