Statens Serum Institut

Csl Behring Ag

Inga Laursen

Gunnar Houen

Charlotte Svaerke Joergensen

Børge Teisner

B&oslash;rge Teisner

The present nanofiltration method is applicable on solutions of plasma-derived and recombinantly produced MBL. The MBL containing solution is subjected to a pre-treatment prior to the nanofiltration step. The nanofiltration is used for removal of viruses in general and other infectious agents to obtain an MBL product free from infectious viruses and agents. The nanofiltered MBL product is ready for preparing a pharmaceutical composition for therapeutic or prophylactic treatment of infections and other diseases in individuals with MBL deficiency and insufficiency.

Method comprising nanofiltration to obtain an MBL product safe from infectious agents and the product obtainable by this method

The present invention relates to a process for purifying immunoglobulin G from a crude immunoglobulin-containing plasma protein fraction. Said process includes a number of steps of which the anion exchange chromatography and the cation exchange chromatography are preferably connected in series. An acetate buffer having a pH of about 5.0-6.0 and having a molarity of about 5-25 mM is preferably used throughout the purification process. The invention further comprises an immunoglobulin product which is obtainable by this process. The invention also relates to an immunoglobulin product which has a purity of more than 98%, has a content of IgG monomers and dimers of more than 98.5%, has a content of IgA less than 4 mg of IgA/l, and contains less than 0.5% polymers and aggregates. Said product does not comprise detergent, PEG or albumin as a stabilizer. The product is stable, virus-safe, liquid and ready for instant intravenous administration.

Process for producing immunoglobulins for intravenous administration and other immunoglobulin products

A purification process for large-scale production of Gc-globulin is described. The source of Gc-globulin is preferably a crude plasma fraction but can be any solution, suspension or supernatant containing Gc-globulin, e.g., a milk product, colostrum or a fermentation broth. The Gc-globulin can be plasma-derived or produced by a genetic modified organism. The process includes two key elements: purification by series of ion exchange chromatography steps, and performing at least two virus-reduction steps. A diagnostic method to measure the free Gc-globulin in a patient blood sample, a use of Gc-globulin in medicine and the preparation of a Gc-globulin medicinal product is also provided. The product can be used in therapy for patients with circulatory disorders and complications, i.e., where it is contemplated that patients would benefit from the administration of Gc-globulin.

Purification process for large scale production of Gc-globulin, the Gc-globulin produced hereby, a use of Gc-globulin and a Gc-globulin medicinal product

A purification process for large-scale production of Gc-globulin is described. The source of Gc-globulin is preferably a crude plasma fraction but can be any solution, suspension or supernatant containing Gc-globulin, e.g. a milk product, colostrum or a fermentation broth. The Gc-globulin can be plasma-derived or produced by a genetic modified organism. The process includes two key elements: purification by series of ion exchange chromatography steps, and performing at least two virus-reduction steps. A diagnostic method to measure the free Gc-globulin in a patient blood sample, a use of Gc-globulin in medicine and the preparation of a Gc-globulin medicinal product is also provided. The product can be used in therapy for patients with circulatory disorders and complications, i.e. where it is contemplated that patients would benefit from the administration of Gc-globulin.

Purification process for large scale production of Gc-globulin, the Gc-globulin produced hereby, a use of Gc.globulin and a Gc-globulin medicinal product

The starting material for the present purification process is a supernatant, suspension, milk product, colostrum or crude plasma protein fraction containing MBL. The starting material is subject to few pre-processing steps in order to obtain an MBL containing solution. By this it is possible to perform an affinity chromatography as the first chromatographic process step employing a non-conjugated polysaccharide matrix, from which MBL of a high purity is eluted. Besides constituting the major purification step of the process, the affinity chromatography also serves as a virus-removal step. In the production process of a virus-safe product, a virus-inactivation step is also included. The product of the process of the present invention is ready for use as medicinal product.

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Hellerup, Denmark

Inga Laursen