Plasma-derived medicinal products
Plasma-derived medicinal products (PDMPs) are industrially manufactured from human plasma by pharmaceutical companies. Plasma is the liquid part of blood and it can be collected through specific procedures called plasmapheresis or obtained by the separation from the other components through physical means (centrifugation). PDMPs play a key, and sometimes non-replaceable, role in the treatment of many acute and chronic clinical conditions.
Considering the biological nature of PDMPs, their quality and safety is based on strict controls on plasma as well as on the industrial processing (fractionation), including methods of viral elimination or inactivation.
In Italy, the plasma collected and industrially processed exclusively comes from voluntary, anonymous and unpaid donations carried out for the most part by regular donors.
Plasma-derived medicinal products from national plasma and their clinical indications.
Human albumin is a plasma protein produced by the liver and it represents about 60% of all plasma proteins. Its concentration in blood ranges between 3.5 and 5 g/decilitres. Possible lower values of human albumin are to be found, in most cases, in a reduced production of albumin by the liver. Human albumin is appropriate for the treatment of many hepatic diseases as well as of the paracentesis with ascites, the spontaneous bacterial peritonitis, the hepatorenal syndrome, the therapeutic plasma exchange and occasionally when other clinical conditions involve the reduction of blood volume (BIBLIO).
Immunoglobulins (IG) are used in the replacement therapy of the immunodeficiencies and in the treatment of autoimmune diseases or systemic inflammatory processes. They are considered as the driver products because of the constant increasing trend of their demand worldwide. Since 2007, IG are available both for subcutaneous/intramuscular (SC/IM) administration as well as for intravenous use (IntraVenous, IV).
The IG as well as all other PDMPs are prepared by the use of pools of human plasma resulting in a significant idiotypic diversity that guarantees a higher antibody protection to the recipient. Preparations structurally and functionally contain intact IG, with normal half-life values and ratios of subclasses: 95% of monomeric IGG, small quantities of dimers, variable quantities of IGA and IGM.
Antithrombin is a glycoprotein synthesised by the liver. It is present in plasma with a concentration of about 150 μg/mL. Antithrombin is an inhibitor of the protease, belonging to the family of serpins or inhibitors of the serine protease. It is the most powerful natural inhibitor of the coagulation and it plays a fundamental role in guaranteeing the haemostasis balance.
Antithrombin inhibits the action of all activated factors of the coagulation, except the factors V and VIII; indeed, it has a particular affinity to the thrombin and is also called “co-factor” of the heparin. Antithrombin can be used in the treatment of congenital deficiencies of this glycoprotein.
Coagulation Factor VIII concentrates (FVIII) are used in the replacement therapy of the haemophilia A, which is a rare, haemorrhagic, hereditary, recessive and sex-related disease, caused by a deficit of the FVIII. The activity level of FVIII helps to classify haemophilia A as severe (FVIII < 1%), moderate (between 1 and 5%) and mild (between 30 and 40%).
Coagulation factor IX concentrates (FIX) are used in the replacement therapy of the haemophilia B, also called “Christmas disease”. The latter is a rare, haemorrhagic, hereditary, recessive and sex-related disease, with an estimated prevalence of 2-3/100.000 male subjects, and caused by a deficit of the FIX. The activity level of FIX helps to classify haemophilia B as severe (FIX< 1%), moderately moderate (between 1 and 5%) and mild (under 5%).
Coagulation factor VII concentrates (FVII) is a vitamin K-dependent glycoprotein that triggers the coagulation cascade in blood. The congenital defect linked to the FVII factor is a rare haemorrhagic disorder due to a genetic anomaly of chromosomes. It is an autosomal recessive disease. The replacement therapy is essential for patients with a severe phenotype.
Coagulation factor XIII (FXIII), also known as a stabilising factor of the fibrin, is used in the replacement therapy of the congenital deficiency of the same protein, an autosomal recessive disease whose prevalence is estimated in about 1/2.000.000. Severe (FXII <1%), moderate (between 1 and 4%) and mild forms (FXIII >5%) are distinguished according to the activity level of FXIII.
Prothrombin Complex Concentrates (CCP) are used to correct acute or temporary deficiency of factors belonging to the prothrombin-related complex. CCP with three or four factors can be produced through appropriate chromatographic techniques. The CCP3 contain the factors II (FII), FIX and X (FX), the CCP4 contain FII, FVII, FIX, FX with a procoagulant effect, as well as natural and physiological inhibitors of the coagulation such as the protein C, S and traces of AT, heparin and vitronectin.
Fibrinogen is one of the most abundant coagulation factors in the plasma. The thrombin converts it into fibrin and it represents the main component of the coagulation. Therefore, fibrin can be considered both a structural protein and a coagulation factor. A fibrinogen deficiency means a lower coagulating power of blood, with consequent greater tendency to bleed. Firstly, fibrinogen is used in the treatment and prophylaxis of haemorrhages partially or totally caused by a serious deficit of fibrinogen.
Reference standardsBlood and plasma represent precious and limited resources characterized by a strong ethical value because derived from the voluntary, responsible and unpaid donation and they can become under no circumstances source of profit, for the sake of consistency and by analogy with principle of non-commercialisation of the human body and its parts contained in the main European treaties and documents (Oviedo Convention, 1997).
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