Three specialised GEA chamber separators for blood plasma fractionation, including the BKI 45, have been installed in the fractionation plant at Bila Tserkva
GEA has supported Biopharma with the delivery of further separators for blood plasma fractionation. Biopharma is a Ukrainian pharmaceutical company focused on the development and production of drugs based on human plasma. The equipment has been installed at Biopharma's Bila Tserkva plant. Separators already supplied, such as a GEA separator BKA 6 for blood plasma fractionation in 2004, two Pathfinders PSC 8 (probiotics) in 2014, and separators PKI 45, BKB 28, one BKA 45 and two BKI 45 to date, represent a more than 15 year collaboration.
Specific examples of Biopharma's products produced using GEA technologies include blood coagulation factor VIII (Factor VIII, F8), also known as Antihemophilic Globulin A, a drug for hemophilia patients. An acute deficiency of the glycoprotein or lack of this clotting factor in humans and vertebrates leads to hemophilia A, the so-called hemophilia. Biopharma also produces albumin.
The company also produces antibodies including the very one that the BKI 45 separators are instrumental in driving forward in the context of blood plasma fractionation. Antibodies are proteins from the globulin class that are used to strengthen the body's protective functions for example in the case of immune deficiencies, autoimmune diseases or acute infectious diseases.
Three specialised GEA chamber separators for blood plasma fractionation, including the BKI 45, have been installed in the fractionation plant at Bila Tserkva. These separators are designed for fractionation of human blood plasma proteins. The BKI 45 has its own cooling system, which includes the bowl, hood and frame. In addition, the machine can be protected against power failure, for example, by the GEA plasmacool skid.
Proteins are separated and accumulated in the chamber of the separator bowl and periodically removed manually. Centrifuges with a dual-circuit cooling system are used for fractionation. Liners in the separator bowl divide it into two chambers. The product is fed into the center of the bowl and then flows from the centre to the periphery of the bowl through the two chambers, where the particulate fraction is separated and the solids are removed. The separation efficiency remains the same until the chamber is filled.
Blood fractionation refers to the process of separating plasma derived from blood into its individual components. Plasma is the liquid part of blood and accounts for about 55% of the total volume. It is composed primarily of water and contains small amounts of dissolved minerals, salts, iron, nutrients and proteins. It serves as a transport and storage medium for erythrocytes (red blood cells), leukocytes (white blood cells) and platelets (thrombocytes).
GEA has developed numerous products for both blood fractionation and vaccine production and brought them to the global market. Human blood plasma fractionation provides purified and concentrated proteins that are then used to develop drugs or vaccines. The process of blood plasma fractionation is complex and requires in-depth knowledge of both the process and the specific equipment, it says.
The design, construction and installation of an integrated fractionation facility is an extremely complex and challenging undertaking, GEA says. It requires precise control of parameters such as pH, ethanol content and temperature. Equally important is the use of appropriate virus inactivation steps, as well as full automation and validation of the entire system.