PLASMA PROJECT

The National Program for the Supply of Plasma – Derived Medicinal Products to the Republic of Croatia is a strategic project with the aim of initiating fractionation/processing of plasma originating from domestic donors at the Institute of Immunology.

Blood components and medicinal products derived from human plasma are two vital therapeutic resources to save lives or to improve the quality of life of patients. Human blood and human plasma are strategic biological materials comparable to other natural materials important for national independence and security of supply.

The Institute of Immunology has been recognized as one of the key institutions responsible of this National Program for the period 2024-2027.

BASIC TERMS

  • BLOOD

    Blood is human blood collected from a donor in an anticoagulant solution for processing into blood components for transfusion treatment or for further processing into plasma – derived medicinal products.

  • BLOOD COMPONENT

    A blood component is a part of the blood collected from a donor (plasma, erythrocytes, leukocytes, platelets).

  • BLOOD PRODUCT

    A blood product is any therapeutic preparation for transfusion treatment derived from human blood or a blood component (not an industrially produced medicinal products.

  • HUMAN PLASMA

    Human plasma is a blood component separated from whole blood collected from a donor or obtained by the plasmapheresis procedure (donors donate only plasma, not whole blood, and their blood cells are returned to the bloodstream).

    Like blood donation, plasma donation is part of the key critical healthcare infrastructure in the Republic of Croatia.

    Human plasma is a source of clinically valuable and important proteins: albumin, immunoglobulins, clotting factors, etc. It is collected in national transfusion institutions (authorized transfusion centers in the Republic of Croatia) and non-profit government organizations (Red Cross) on the basis of voluntary unpaid donations.

  • PLASMA PROCESSING

    Fractionation is the industrial process of separating and purifying human plasma into plasma derived medicinal products.

  • MEDICINAL PRODUCTS DERIVED FROM HUMAN BLOOD OR HUMAN PLASMA

    • A medicinal product derived from human blood or human plasma is an industrially manufactured medicinal product, which is based on blood components such as: albumin, coagulation factors and immunoglobulins of human origin, taking into account the principle of national self-sufficiency in the supply of these medicinal product
    • Medicinal product that saves human lives, and in patients with rare diseases, extend life expectancy and improve the quality of life
    • Essential medicinal product included in the basic list of medicinal products of the World Health Organization and the Croatian Health Insurance Fund
    • Meet the priority healthcare needs of the population
    • Are available in the Republic of Croatia at all times with guaranteed quality
    • Have wide application in almost all branches of medicine
  • PRINCIPLE OF SELF-SUFFICIENCY

    Principle of national self – sufficiency supply of blood and blood components and medicinal products derived from human plasma. The realization of the principle of self-sufficiency, according to which each country should be self-sufficient in terms of blood, blood components and blood derivatives, implies the collection of plasma on its territory from its own population, given that such blood-plasma contains antibodies formed in contact with domicile pathogens (antigens).

REVITALIZATION OF PRODUCTION

  • Human Normal ImmunoglobinIZ IVIG 50 mg/ml solution for infusion
  • Human AlbuminAlbumin (human) 20% solution for infusion
  • Human AlbuminAlbumin (human) 50 g/l solution for infusion

NATIONAL PLAN (2019 – 2022) AND NATIONAL PROGRAM (2024 – 2027)

Until the start of operation of the new manufacturing facilities at the Rugvica site, the Institute of Immunology will receive plasma from all transfusion centers, store it and send it for processing to the selected contract fractionator with a contractual obligation to return the finished drugs to the Croatian market.

  • Institute of Immunology as a central place for plasma storage (MODEL A):

    Institute of Immunology cooperate contractually with authorized health institutions – transfusion centers in the Republic of Croatia:

    • Croatian Institute for Transfusion Medicine, Zagreb,
    • Clinical Hospital Centre Osijek,
    • Clinical Hospital Centre Rijeka,
    • Clinical Hospital Centre Split
    • General Hospital Dubrovnik
    • General Hospital Varaždin
    • General Hospital Zadar.

    Institute of Immunology (Ministry of Health of the Republic of Croatia, State Budget) provides the financial resources necessary for the purchase of plasma from transfusion centers, for transport and for plasma storage.

  • WE COOPERATE CONTRACTUALLY WITH A SELECTED FRACTIONATOR

    The Institute of Immunology (Ministry of Health of the Republic of Croatia, State Budget) ensures the accumulation of financial resources by selling stored plasma for further processing to a contractual fractionator with the obligation to return finished drugs to the market of the Republic of Croatia, and which revenues constitute the assets of the Institute. The surplus revenues generated are used exclusively for the performance and development of the activities of the Institute of Immunology.

Prihodi

Prihodi 2022 2023
Prihodi od prodaje proizvoda i robe te pruženih usluga (šifre 6614+6615) 3.687.345,39 3.524.485,99
Višak prihoda – preneseni (šifre 92211+92212-92221-92222) 4.774.439,22 5.898.120,36