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Cooperation with Octapharma for German-speaking markets
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Fourth-generation recombinant human factor VIII preparation from a human cell line
DREIEICH, Germany I November 3, 2016 I Biotest AG will be adding a recombinant factor VIII preparation to its haemophilia portfolio which will be produced by using a human cell line from early 2017 on. The new product is indicated for the treatment and prevention of bleeding episodes in children and adults with haemophilia A (congenital factor VIII deficiency). It is intended to be a high-quality alternative for patients who favor a recombinant product to the recombinant factor VIII preparations available to date. In studies in previously treated patients, the fourth-generation recombinant clotting factor has proved to be safe, effective and well tolerated. Biotest will market the new factor VIII preparation in Germany, Austria and Switzerland in a cooperation agreement with Octapharma AG, Lachen, Switzerland.
The factor VIII preparation is produced from a human cell line and thereby recreates a wild-type preparation like Biotest’s Haemoctin®. Unlike conventional recombinant factor VIII preparations, which are produced using hamster cells, the wild-type factor VIII shows natural human structures.
“With a recombinant factor VIII preparation from a human cell line, which has many of the advantages of a natural plasma clotting factor, we are continuing our wild-type strategy consistently,” states Dr Thomas Becker, Senior Director Haematology of Biotest AG. “We can now offer an alternative to patients who together with their doctor deliberately opt for a recombinant factor VIII preparation.”
About recombinant factor VIII
A recombinant clotting factor VIII is produced using biotechnology and is not obtained from human blood plasma. The blue print (i.e., the gene) for human factor VIII is introduced into a mammalian cell and inserted into in the DNA, so it “combines” with the existing genetic material. Hamster cells, which read the human gene and then produce factor VIII, are generally used as mammalian cells. Despite the incorporated human gene, however, a hamster cell is not capable of producing a factor VIII that corresponds exactly to the human model. There are small structural differences that can affect tolerability. The recombinant factor VIII that Biotest will launch on the market is produced in a human cell and thus comes closest to the natural human model.
About Biotest
Biotest is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. In addition Biotest develops monoclonal antibodies in the indications of cancer of plasma cells and systemic lupus erythematosus which are produced by recombinant technologies. Biotest has more than 2,400 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.
SOURCE: Biotest
Post Views: 701
-
Cooperation with Octapharma for German-speaking markets
-
Fourth-generation recombinant human factor VIII preparation from a human cell line
DREIEICH, Germany I November 3, 2016 I Biotest AG will be adding a recombinant factor VIII preparation to its haemophilia portfolio which will be produced by using a human cell line from early 2017 on. The new product is indicated for the treatment and prevention of bleeding episodes in children and adults with haemophilia A (congenital factor VIII deficiency). It is intended to be a high-quality alternative for patients who favor a recombinant product to the recombinant factor VIII preparations available to date. In studies in previously treated patients, the fourth-generation recombinant clotting factor has proved to be safe, effective and well tolerated. Biotest will market the new factor VIII preparation in Germany, Austria and Switzerland in a cooperation agreement with Octapharma AG, Lachen, Switzerland.
The factor VIII preparation is produced from a human cell line and thereby recreates a wild-type preparation like Biotest’s Haemoctin®. Unlike conventional recombinant factor VIII preparations, which are produced using hamster cells, the wild-type factor VIII shows natural human structures.
“With a recombinant factor VIII preparation from a human cell line, which has many of the advantages of a natural plasma clotting factor, we are continuing our wild-type strategy consistently,” states Dr Thomas Becker, Senior Director Haematology of Biotest AG. “We can now offer an alternative to patients who together with their doctor deliberately opt for a recombinant factor VIII preparation.”
About recombinant factor VIII
A recombinant clotting factor VIII is produced using biotechnology and is not obtained from human blood plasma. The blue print (i.e., the gene) for human factor VIII is introduced into a mammalian cell and inserted into in the DNA, so it “combines” with the existing genetic material. Hamster cells, which read the human gene and then produce factor VIII, are generally used as mammalian cells. Despite the incorporated human gene, however, a hamster cell is not capable of producing a factor VIII that corresponds exactly to the human model. There are small structural differences that can affect tolerability. The recombinant factor VIII that Biotest will launch on the market is produced in a human cell and thus comes closest to the natural human model.
About Biotest
Biotest is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. In addition Biotest develops monoclonal antibodies in the indications of cancer of plasma cells and systemic lupus erythematosus which are produced by recombinant technologies. Biotest has more than 2,400 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.
SOURCE: Biotest
Post Views: 701
