Plasma derived, such as albumin, clotting factors, gammaglobulin, are pharmaceutical products essential to treat several diseases (infections, immunodeficiencies, hepatitis, etc). Unfortunately, they can only be obtained by fractionating the whole plasma: not an easy procedure that requires a deep knowledge of the issue to have an efficient process and safe products. In this field TECNinox, an Italian engineering company, has a huge experience to share with our readers to help them to build an innovative fractionating plant.
From human plasma to pharmaceutical plasma derived
Plasma derived are plasma components that can be produced only by fractioning the plasma human blood, a very scarce and precious resource. Plasma is obtained by human donors through plasmapheresis. This is an extraction process that take place during a blood donation and allows separating the whole-blood components from plasma. Albumin, immunoglobulins and solutions of plasma proteins are the main plasma derived obtained by plasma. The plasma is taken from several human donors, and then is collected in bags and frozen to preserve it during the transport to the pharmaceutical plants where it is worked in order to separate the plasma derived. Generally, the thawing is made according to very restrictive parameters of temperature and time.
The thawed plasma is now ready to have its proteins isolated and separated by fractioning. Taking advantage of the different solubility of the plasma proteins in different chemical or physic conditions (eg. pH, temperature, ionic strength, ethanol concentration) it is possible to make insoluble some of the proteins, previously dissolved in the plasma, and precipitate them in large clumps. The precipitated proteins are separated from the plasma by centrifugation. The conditions applied depend on the type of plasma derived to be produced. At this stage, it is very important to have the right equipment that can assure the optimum control of the process.
The precipitate is processed to obtain the clotting factors Factor VIII, Factor XIII and von Willebrand factor and fibrinogen. From the precipitate it is possible to isolate also fibronectin and, by addition of calcium and thrombin, fibrin glue, a product used in surgery to promote the healing of the sutures due to its haemostatic properties.
The surnatant, instead, is used to extract other clotting factors, such as factor IX and VII, immunoglobulins, and albumin by using a sequence of several separation processes such as cryoprecipitation, precipitation with ethanol, or Cohn method, and several types of chromatography (gel precipitation, ion exchange chromatography, and affinity chromatography).
In particular, the immunoglobulins are obtained from plasma collected from donors specifically immunized against the desired antigen, eg. Hepatitis B Virus or tetanus toxin.
The final step of the process is dedicated to get safe pharmaceutical products thanks to virus inactivation. This is a process that take place through several processes such as pasteurization (heating in aqueous solution, 60°C for10 h), heating of freeze dried products, detergent/solvent treatment (Triton X, Tween 80), nanofiltration, low pH, chromatography, sterile filtration.
TECNinox expertise on fractioning plants
The design and the building of a fractioning plant and of its equipments is far more than easy and obvious, as the plant is not a simple sequence of big tanks.
The Italian engineering company based in Noceto (Parma), Tecninox, has designed and developed several fractioning plants for leading pharmaceutical companies, acquiring a good knowledge of the plasma fractioning process.
For a pharmaceutical company, working with TECNinox means to be involved in the design process of a plant very early: as soon as TECNinox’s staff had defined the Piping and Instrumentation Diagrams (P&ID) and developed a 3D design of the plant, the whole project is discussed with the customer’s staff (Engineering, Production, Maintenance, Environmental, Health and Safety (EHS).
TECNinox expertise on virus inactivation
Plasma is an organic product originated by humans and can potentially contain bacteria, TECNinox has a strong expertise on automated Cleaning in Place (CIP) systems and can guarantee a perfect washing of lines and tanks.
TECNinox experts pay a special attention to insulation systems between clean area (C class) and technical ones.
Fractioning and viruses inactivation are complex processes and have to be based on an engineering study, that is possible and reliable only if performed by professionals with a deep understanding of the these processes in their complexity and totality.
For 35 years TECNinox and its associated companies have offer an innovative environment,where more than 200 people work together to manage the requests of the pharmaceutical industries. The ability of TECNiniox professionals is to take care of the customer’s needs and requests starting from their very first contacts in order to supply turnkey solutions. In addition, over the years, Tecninox has acquired an extensive knowledge of plasma derived production processes, a knowledge that translates into competence and reliability made available to TECNinox customers.
What’s blood products made for our health
Plasma is the liquid part of blood that contains proteins, nutrients, metabolic products, hormones and inorganic electrolytes. Pharmaceutical products originated by plasma and its fractions are essential to cure many severe and life-threating diseases. Albumin, for example, is used for patients with severe liver disease; coagulation factors help patients with haemophilia, while gamma globulins prevent or treat several infectious diseases