A priceless resource for life
02 Aug 2021
Only the body is capable of producing blood and therefore also blood plasma; it cannot be artificially reproduced. Blood plasma processed with GEA technology and the products made from this plasma help people whose blood can no longer do its job due to illness, after and during operations, due to cancer treatments or after serious accidents and injuries.
Blood plasma is the non-cellular part of the blood that is made up of approximately 90 percent water and ten percent of the substances dissolved in it. It makes up around 55 percent of the blood volume; the cellular blood components make up about 45 percent (hematocrit). The total quantity of the blood plasma in the body is called the plasma volume. The most important components of blood plasma are:
- Electrolytes (NA+, Cl-, K+, Ca2+, Mg2+, bicarbonate, phosphate)
- Plasma proteins (albumins, lipoproteins, immunglobulin, fibrinogen)
- Nutrients (e.g. glucose, lipids)
- Organic acids (e.g. lactate, pyruvate, citrate)
- Decomposition products of the various metabolic pathways (creatinine, creatine, uric acid)
- Hormones (signal molecules)
Blood plasma – a miracle weapon in the human defence system
The individual components of the plasma have many important functions that cannot be otherwise substituted.
For instance, the plasma proteins take on a number of different and very important tasks in the human body.
First of all, they are an important component of the central immune system in the body because they transport antibodies, so-called ‘globulins’, and enzymes that act as antigens of the blood and therefore protect the organism from external attacks.
In addition, the plasma proteins can bind various materials and also insoluble substances so they can be transported through the body. The ‘delivery function’ of the plasma proteins is very important for supplying the body the nutrients it requires to the right places thereby enabling various parts of the body to ‘communicate’.
Certain proteins of the plasma called ‘fibrinogens’ and ‘prothrombins’ ensure blood coagulation in the human body. They are removed from the plasma and work with the blood cells and the surface of the wound to stop the bleeding. A further protein, called ‘albumin’, prevents blood leaking from the veins.
Blood plasma is also an option in the fight against Sars-CoV-2
For instance, the administration of antibodies against Sars-CoV-2 is a possible and promising treatment option in the fight against COVID-19. Once a person infected with a virus has recovered, their blood is rich in antibodies. The advantage, in particular for immunocompromised patients, is that the antibodies have already been produced. However, the downside of this method is that it depends greatly on an adequate number of willing volunteers.
Experts for blood plasma fractionation
Plasma fractionation is a procedure for recovering proteins from blood plasma, and involves separating the plasma into individual fractions and purifying it by means of various physical methods. Fractionation of human blood plasma delivers purified and concentrated proteins with which drugs for intensive and emergency medicine, and also rare diseases are produced.
GEA has developed numerous innovative improvements, both for blood fractionation and also for the production of vaccines, which are being launched onto the global market. Blood fractionation is complex and requires in-depth expertise both with respect to the process and also to the equipment required to achieve a high yield within a cost-effective timeframe.
First, the white blood cells and the thrombocytes are removed. The remaining red blood cells and the plasma are then separated in special centrifuges. The plasma is frozen and, once it has been thawed, various components, e.g. cryoprecipitate, factor VIII, can be separated. Then the remaining plasma undergoes ethanol fractionation. This allows the recovery of plasma proteins, such as fibrinogen, gamma globulin, alpha globulin and beta globulin, and also albumin.
By the way: only about five percent of the plasma is used for fractionation, the majority is water and electrolytes.
Leap up the global ranking of high-text plasma processors using the GEA technology
The customer Biopharma from Ukraine is currently profiting from GEA competence in its blood plasma fractionation processes. GEA supports its long-standing partner Biopharma with the delivery of further state-of-the-art separators for blood plasma fractionation. Biopharma is a Ukrainian pharma company that concentrates on the development and production of pharmaceutical products based on human plasma. The systems were installed in Biopharma’s new plant in Bila Tserkva. These new systems not only supply high-quality products to the Ukraine, but also allow it to assume a leading position in the global ranking of high-tech plasma processors. Previously supplied separators such as in 2004, a GEA-Separator BKA 6 for blood plasma fractionation and since 2018 to the current day separators PKI 45, BKB 28, a BKA 45 and two BKI 45 are an indication of the successful cooperation between GEA and this Ukrainian company for more than 15 years.
GEA supplies separators to Ukrainian company Biopharma. (Photo: GEA)
Planning, designing and installing an integrated fractionation system is an extremely complex and technically demanding task. It involves more than just simply connecting units, it requires the precise control of parameters, such as pH value, ethanol level and temperature. Just as important is the use of suitable virus inactivation steps, as well as full automation and validation of the entire system.
Dr. Markus Kühberger
Head of Business Line Chemical & Pharma - BU Separators
One specific example of products by Biopharma that are produced with GEA technologies, includes coagulation factor VIII (Factor VIII, F8), also known as Antihemophilic globulin A, a vital drug for haemophilia patients. An acute deficiency of glycoprotein or a lack of this clotting factor in humans and vertebrates causes haemophilia A. Biopharma also produces albumin. Albumins, like globulins, belong to the group of globular proteins. Albumin is specifically responsible for maintaining the colloid-osmotic pressure in the human body, and makes otherwise insoluble substances soluble by binding them with albumin. It is used especially for renewal and maintenance of circulating blood volume after injuries and during surgical procedures. The production of immunoglobulins (‘antibodies’) is a further key area for Biopharma and is driven by the new BKI 45 separators primarily during blood plasma fractionation. Antibodies are proteins from the class of globulins that are used to boost the protective function of the body, for instance in case of immune defects, autoimmune diseases or acute infectious diseases. These antibodies also service the immune system.
State-of-the-art separators are used for blood plasma fractionation. (Photo: GEA)
The GEA technology human blood separator BKI 45
Three specialized GEA chamber separators for blood plasma fractionation, including the BKI 45, were installed in the new fractionation system in the new Bila Tserkva plant. These separators are designed for fractionation of human blood plasma proteins. The BKI 45 has its own cooling system that reliably guarantees the mandatory process temperature of +2° C to – 7° C and includes the bowl, hood and the top of the frame.
Valuable proteins are separated, collected in the chamber of the separator bowl, and are manually removed periodically. Centrifuges with a triple-circuit cooling circuit are used for fractionation. The bowl inserts divide the bowl in two chambers.
The product is fed into the center of the rotating bowl through the feed. It flows from the center to the periphery through both chambers, wheras the finer particles are separated out in the outer chamber. The clarifying efficiency remains constant until the chambers are filled with proteins.
In package unit design, the machine can be installed in a two-room concept whereby the emission-free, water-cooled integrated direct drive is suitable for the strictest of clean room classes. The compact design ensures significant reduction of the space requirements in expensive clean rooms. The utility package unit is located in the technology area.
GEA hycon® as a next step: self-cleaning as well as SIP and CIP, all fully automatic
In its efforts to continuously improve, GEA has launched a new technology: the GEA Separator hycon® which is a pioneer for fully automatic one-touch production in blood plasma fractionation. To separate blood plasma and plasma proteins, GEA offers an ideal solution in the fully automatic GEA-Separator hycon®.
The centrifuge automatically discharges the collected solids, no manual removal is needed, solids handling can be customized. For instance, the separated solids can be collected in a bag that is placed into a tank. This closed process substitutes conventional manual removal of the solids from the separator bowl. The advantages of the closed handling are the greatly improved hygiene conditions and the associated easier sterilizability, prevention of cross-contamination, higher batch-safety and improved Good Manufacturing Practice documentation (GMP); Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) were previously impossible in chamber bowl machines.
A further decisive advantage are the reduced downtimes required for emptying the chamber bowls manually. The maintenance work on the separator is reduced significantly thanks to the technical solution of the ‘suspended bowl’. The hycon® therefore contributes to GMP-conform working and quality assurance of the production processes and environment in pharmaceutical production. The attractive three-room installation reduces the space required in clean rooms to a minimum.
With GEA separator hycon® and the 3-room concept, GEA is way ahead in the field of fully automated production in cleanroom applications. (Photo: GEA)
