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DOI: 10.1055/a-1894-1146
Hyperimmunplasma: Gewinnung, Verarbeitung und therapeutische Anwendungen
Hyperimmune Plasma: Collection, Processing and Therapeutic ApplicationsZusammenfassung
Das Prinzip der passiven Immunisierung ist seit dem 19. Jahrhundert bekannt und wird auch bei aktuellen Pandemien als Ansatz zur Prophylaxe und Therapie eingesetzt. Der Schutz wird hierbei übertragen durch Blut, Serum oder Plasma, welche Immunglobuline gegen spezifische Krankheitserreger, Bakterientoxine oder sonstige Antigene enthalten, sowie durch aus Humanplasma industriell aufgereinigte Immunglobuline. Die aktuell verwendeten Reinigungsverfahren für Immunglobuline aus Humanplasma beruhen auf der von Edwin J. Cohn entwickelten Fraktionierung von Plasma. Zur Gewinnung von Immunglobulinen mit hohen Antikörpertitern gegen spezifische Antigene, sogenannte Hyperimmunglobuline, muss zunächst Hyperimmunplasma gezielt von ausgewählten Spendern gewonnen werden. Diese Spender haben erhöhte Antikörpertiter gegen spezifische Krankheitserreger, Bakterientoxine oder sonstige Antigene, wenn sie im Rahmen einer vorangegangenen Infektion natürlich immunisiert wurden, einen zugelassenen Impfstoff zur Immunisierung erhalten haben oder gezielt zum Zweck der Plasmaspende immunisiert wurden. Aktuell sind in Deutschland, Österreich und der Schweiz Hyperimmunglobulinprodukte für verschiedene Anwendungen im Patienten zugelassen, von denen die meisten aus humanem Blutplasma gewonnen werden. Um die Herstellung der Produkte und damit letztlich die Behandlung der Patienten gewährleisten zu können, werden resiliente Lieferketten benötigt. Hierzu bedarf es unter anderem Änderungen in den Rahmenbedingungen für die Spenderimmunisierung in Deutschland.
Abstract
The concept of passive immunization has been known since the 19th century and is also used in current pandemics as an approach to prophylaxis and therapy. Protection is conferred by blood, serum or plasma containing immunoglobulins against specific pathogens, bacterial toxins or other antigens, as well as by immunoglobulins industrially purified from human plasma. The currently used purification methods for immunoglobulins from human plasma are based on the fractionation of plasma developed by Edwin J. Cohn. To obtain immunoglobulins with high antibody titers to specific antigens, so-called hyperimmunoglobulins, hyperimmune plasma must first be obtained from selected donors. These donors have elevated antibody titers against specific pathogens, bacterial toxins or other antigens if they have been naturally immunized as part of a previous infection, have received an approved vaccine for immunization or have been specifically immunized for the purpose of plasma donation. Currently, hyperimmunoglobulin products are approved in Germany, Austria and Switzerland for various applications in patients, most of which are derived from human blood plasma. Resilient supply chains are needed to ensure the manufacture of the products and ultimately the treatment of patients. This requires, among other things, changes in the framework for donor immunization in Germany.
Publication History
Article published online:
21 February 2023
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