The new equipment will not only enable Biopharma to supply Ukraine with high-quality products, but also to take a leading position in the world ranking of high-tech plasma processors. 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 successful cooperation of GEA with the Ukrainian company for more than 15 years.
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 vital 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. Like globulins, albumins belong to the group of globular proteins. In the human organism, albumin is primarily responsible for maintaining colloid osmotic pressure and imparts water solubility to many otherwise water-insoluble substances by binding them to albumin. It is used especially for renewal and maintenance of circulating blood volume in case of injuries and during surgical interventions. Finally, the production of immunoglobulins ("antibodies") represents another focus of Biopharma and the very one that the new 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. These antibodies are thus at the service of the immune system.
Three specialized GEA chamber separators for blood plasma fractionation, including the BKI 45, have been installed in the new fractionation plant at the new Bila Tserkva plant. These separators are designed for fractionation of human blood plasma proteins. The BKI 45 has its own reliable 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.
Valuable 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 center 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 percent 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 innovative improvements for both blood fractionation and vaccine production and brought them to the global market through GEA expert teams and technologies. 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 to achieve high yields in a cost-effective timeframe.
In the fight against coronavirus, for example, the administration of antibodies to Sars-CoV-2 is a possible and promising treatment option. Once someone is infected with a virus and has recovered, their blood is rich in antibodies. As with a vaccine, administering blood plasma infected with antibodies to a sick patient could speed their recovery. The advantage, especially for immunocompromised patients, is that the antibodies have already been produced. The downside, however, is the absolute requirement of a sufficient number of willing donors. The design, construction and installation of an integrated fractionation facility is an extremely complex and challenging undertaking. It is not just a matter of simply connecting different units, but also 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.
With modules that can be combined and automated to ensure maximum flexibility, high yields, efficient and reliable operation for a long lifetime, GEA is committed to developing and delivering customer-oriented solutions. The company's extensive experience in plant-specific process implementation has been proven by the successful completion of countless projects for many customers almost over 20 years.
Dr. Michael Golek
Phone: +49 211 9136 1505
GEA Group Aktiengesellschaft
Tel +49 211 9136-0
GEA is one of the world’s largest systems suppliers for the food, beverage and pharmaceutical sectors. The international industrial technology group specializes in machinery and plants as well as advanced process technology, components and comprehensive services.
With more than 18,000 employees, the group generated revenue of more than EUR 4.6 billion in fiscal year 2020. A major focus is on continuously enhancing the sustainability and efficiency of customers’ production processes. GEA plants, processes and components help achieve significant reductions in carbon emissions, plastic use and food waste in production worldwide. In this way, GEA makes a decisive contribution toward a sustainable future, fully in line with its corporate philosophy of “engineering for a better world.” GEA is listed in the German MDAX and the STOXX® Europe 600 Index, and is also among the companies comprising the DAX 50 ESG and MSCI Global Sustainability Indices.
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