Preparation and Storage of Cryoprecipitate Derived from Amotosalen and UVA-Treated Apheresis Plasma and Assessment of In Vitro Quality Parameters
Cryoprecipitate is a plasma-derived blood product, enriched for fibrinogen, factor VIII, factor XIII, and von Willebrand factor. Due to infectious risk, the use of cryoprecipitate in Central Europe diminished over the last decades. However, after the introduction of various pathogen-reduction techno...
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MDPI AG
2022-07-01
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| Series: | Pathogens |
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| Online Access: | https://www.mdpi.com/2076-0817/11/7/805 |
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| author | Katarina Kovacic Krizanic Florian Prüller Konrad Rosskopf Jean-Marc Payrat Silke Andresen Peter Schlenke |
| author_facet | Katarina Kovacic Krizanic Florian Prüller Konrad Rosskopf Jean-Marc Payrat Silke Andresen Peter Schlenke |
| author_sort | Katarina Kovacic Krizanic |
| collection | DOAJ |
| description | Cryoprecipitate is a plasma-derived blood product, enriched for fibrinogen, factor VIII, factor XIII, and von Willebrand factor. Due to infectious risk, the use of cryoprecipitate in Central Europe diminished over the last decades. However, after the introduction of various pathogen-reduction technologies for plasma, cryoprecipitate production in blood centers is a feasible alternative to pharmaceutical fibrinogen concentrate with a high safety profile. In our study, we evaluated the feasibility of the production of twenty-four cryoprecipitate units from pools of two units of apheresis plasma pathogen reduced using amotosalen and ultraviolet light A (UVA) (INTERCEPT<sup>®</sup> Blood System). The aim was to assess the compliance of the pathogen-reduced cryoprecipitate with the European Directorate for the Quality of Medicines (EDQM) guidelines and the stability of coagulation factors after frozen (≤−25 °C) storage and five-day liquid storage at ambient temperature post-thawing. All pathogen-reduced cryoprecipitate units fulfilled the European requirements for fibrinogen, factor VIII and von Willebrand factor content post-preparation. After five days of liquid storage, content of these factors exceeded the minimum values in the European requirements and the content of other factors was sufficient. Our method of production of cryoprecipitate using pathogen-reduced apheresis plasma in a jumbo bag is feasible and efficient. |
| first_indexed | 2024-03-09T10:13:25Z |
| format | Article |
| id | doaj.art-64157c5f4f8543a1ae016beb05505164 |
| institution | Directory Open Access Journal |
| issn | 2076-0817 |
| language | English |
| last_indexed | 2024-03-09T10:13:25Z |
| publishDate | 2022-07-01 |
| publisher | MDPI AG |
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| series | Pathogens |
| spelling | doaj.art-64157c5f4f8543a1ae016beb055051642023-12-01T22:32:55ZengMDPI AGPathogens2076-08172022-07-0111780510.3390/pathogens11070805Preparation and Storage of Cryoprecipitate Derived from Amotosalen and UVA-Treated Apheresis Plasma and Assessment of In Vitro Quality ParametersKatarina Kovacic Krizanic0Florian Prüller1Konrad Rosskopf2Jean-Marc Payrat3Silke Andresen4Peter Schlenke5Department of Blood Group Serology and Transfusion Medicine, Medical University Graz, Auenbruggerplatz 48, A-8036 Graz, AustriaClinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University Graz, Auenbruggerplatz 15, A-8036 Graz, AustriaDepartment of Blood Group Serology and Transfusion Medicine, Medical University Graz, Auenbruggerplatz 48, A-8036 Graz, AustriaCerus, Europe B.V., Stationsstraat 79-D, 3811 MH Amersfoort, The NetherlandsCerus, Europe B.V., Stationsstraat 79-D, 3811 MH Amersfoort, The NetherlandsDepartment of Blood Group Serology and Transfusion Medicine, Medical University Graz, Auenbruggerplatz 48, A-8036 Graz, AustriaCryoprecipitate is a plasma-derived blood product, enriched for fibrinogen, factor VIII, factor XIII, and von Willebrand factor. Due to infectious risk, the use of cryoprecipitate in Central Europe diminished over the last decades. However, after the introduction of various pathogen-reduction technologies for plasma, cryoprecipitate production in blood centers is a feasible alternative to pharmaceutical fibrinogen concentrate with a high safety profile. In our study, we evaluated the feasibility of the production of twenty-four cryoprecipitate units from pools of two units of apheresis plasma pathogen reduced using amotosalen and ultraviolet light A (UVA) (INTERCEPT<sup>®</sup> Blood System). The aim was to assess the compliance of the pathogen-reduced cryoprecipitate with the European Directorate for the Quality of Medicines (EDQM) guidelines and the stability of coagulation factors after frozen (≤−25 °C) storage and five-day liquid storage at ambient temperature post-thawing. All pathogen-reduced cryoprecipitate units fulfilled the European requirements for fibrinogen, factor VIII and von Willebrand factor content post-preparation. After five days of liquid storage, content of these factors exceeded the minimum values in the European requirements and the content of other factors was sufficient. Our method of production of cryoprecipitate using pathogen-reduced apheresis plasma in a jumbo bag is feasible and efficient.https://www.mdpi.com/2076-0817/11/7/805cryoprecipitatepathogen reductionamotosalenin vitrofibrinogenfactor VIII |
| spellingShingle | Katarina Kovacic Krizanic Florian Prüller Konrad Rosskopf Jean-Marc Payrat Silke Andresen Peter Schlenke Preparation and Storage of Cryoprecipitate Derived from Amotosalen and UVA-Treated Apheresis Plasma and Assessment of In Vitro Quality Parameters Pathogens cryoprecipitate pathogen reduction amotosalen in vitro fibrinogen factor VIII |
| title | Preparation and Storage of Cryoprecipitate Derived from Amotosalen and UVA-Treated Apheresis Plasma and Assessment of In Vitro Quality Parameters |
| title_full | Preparation and Storage of Cryoprecipitate Derived from Amotosalen and UVA-Treated Apheresis Plasma and Assessment of In Vitro Quality Parameters |
| title_fullStr | Preparation and Storage of Cryoprecipitate Derived from Amotosalen and UVA-Treated Apheresis Plasma and Assessment of In Vitro Quality Parameters |
| title_full_unstemmed | Preparation and Storage of Cryoprecipitate Derived from Amotosalen and UVA-Treated Apheresis Plasma and Assessment of In Vitro Quality Parameters |
| title_short | Preparation and Storage of Cryoprecipitate Derived from Amotosalen and UVA-Treated Apheresis Plasma and Assessment of In Vitro Quality Parameters |
| title_sort | preparation and storage of cryoprecipitate derived from amotosalen and uva treated apheresis plasma and assessment of in vitro quality parameters |
| topic | cryoprecipitate pathogen reduction amotosalen in vitro fibrinogen factor VIII |
| url | https://www.mdpi.com/2076-0817/11/7/805 |
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