Biotest Pharma Gmbh

Herbert Dichtelmuller

Wolfgang Stephan

Hans Schleussner

Wolfgang Moller

Norbert Kothe

Dieter Rudnick

Michael Kloft

Detlef Piechaczek

Bertram Eichentopf

Henry Hies

Alexander Thrun

A sterile-filtered colostrum solution that contains casein is made by adjusting the pH of a colostrum solution to 2.5 to 3.5 and then filtering it clear and sterile. It is preferably first defatted, and adjusted to pH 5.5 to 8 after the acid treatment but before being filtered.

Colostrum filtered sterile

A method for sterilizing blood, plasma or derivatives thereof by using vitamins or provitamins.

Sterilization of blood and its derivatives with vitamins

The present invention involves a polyvalent hyperimmunoglobulin preparation having activity against gram negative and gram positive bacteria. Such a polyvalent hyperimmunoglobulin preparation is prepared from plasma, serum or whole blood from donors. Donor selection is based upon titer against E. coli J5 antigen or against lipid A antigen.

Polyvalent hyperimmunoglobulin preparation

A method of sterilizing plasma or plasma fractions, including fractions that contain the blood-coagulating Factor VIII by treatment with .beta.-propiolactone or ultraviolet radiation. Treatment with tri-n-butyl phosphate and sodium cholate or Tween 80 is carried out either prior to or simultaneously with the .beta.-propiolactone treatment or ultraviolet radiation.

Method of sterilizing plasma or plasma fractions

A method of producing a virus-safe, storage-stable, and intravenously tolerable immunoglobulin-G preparation. The object is to make the method appropriate for industrial-scale production and economical by means of the enrichment and multistage purification of a plasma that has had the coagulation factors removed from it or of a plasma fraction or serum fraction that contains immunoglobulin G accompanied by treatment with ion exchangers and by ultrafiltration. The precipitant is eliminated, by means of diafiltration or gelfiltration, either from the plasma that has had the coagulation factors removed from it or from the plasma fraction that contains the immunoglobulin G, and the desired ion composition is established. The resulting protein solution is subjected to fractionation over an ion exchanger to separate the immunoglobulin G. The proteolytic enzymes in the resulting immunoglobulin-G solution are removed by means of affinity chromatography over a dye linked sorbent and/or are ihibited by the addition of antithrombin III. The accordingly stabilized immunoglobulin-G solution is treated, at a protein concentration of 20 to 60 g/l and a pH 6.0 to 8.0, with 0.03 to 0.07% of .beta.-propiolactone, diluted to a protein concentration of 5 to 20 g/l and subjected to ultraviolet radiation. The accordingly sterilized dilute immunoglobulin-G solution is again diafiltered or gelfiltered to remove lower molecular-weight substances. The accordingly stabilized and sterilized solution is adjusted to the desired protein content of 2 to 16% and filtered sterile.

Method of producing a virus safe, storage-stable, and intravenously

A compositon for treating diseases which comprises a therapeutically effective amount of an antibacterial, antiviral, or antimycotic agent, antitrypsin, antithrombin, interferon, or lysozyme, and an immunoenhancing amount of immunoglobulins IgG, IgM, and IgA, and a method of therapy of a mammal in need thereof are disclosed.

Combination of immunoglobulins with therapeutic agents

A method of preparing a solution of lactic or colostric immunoglobulins or both by processing milk or colostrum or both accompanied by precipitation of the caseins, characterized in that milk or colostrum or both are acidified to a pH of 4.0-5.5, subjected to cross-flow filtration in a filtration unit with a mean pore size of 0.1-1.2 .mu.m, and the low-molecular components removed by means of further cross-flow filtration in another filtration unit with a limit of separation of 5 000-80 000 daltons, as well as an agent for treating bacterial and viral infections that consists of a solution obtained by means of said method.

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Sulzbach, Germany

Herbert Dichtelmuller