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A potentially improved approach to methylene blue virus inactivation of plasma: the Maco Pharma Maco-Tronic system
V S Hornsey1, O Drummond, D Young
1Transfusion Service, National Science Laboratory, Edinburgh, UK. valerie.hornsey@snbts.csa.scot.nhs.uk
Abstract:
Plasma was subjected to methylene blue (MB) photochemical virus inactivation using the Maco Pharma Maco-Tronic system which allows three units to be illuminated together, thus reducing processing time. The plasma bag system used incorporates an integral membrane plasma filter and a dry MB pill which dissolves in the plasma to give a 1-microM concentration. There is computer-controlled processing and datalogging. In an assessment of 10 pools of Group A plasma, the losses of coagulation factors, following MB/light treatment, were 23% fibrinogen, 10% FV, 26% FVIII, 11% FIX and 13% FXI. Group O, Group B and Group AB plasmas were not tested. Von Willebrand factor (vWf) multimers showed no substantial change when treated with MB, and no losses were seen for antithrombin III (ATIII), protein C and vWf:Ag. Measurements of C3a, C5a, prothrombin fragment 1+2 and FXIIa indicated that there was no activation as a result of filtration.
Insights
Methylene blue (MB) photochemical treatment effectively inactivates viruses in plasma. While some coagulation factors showed minor losses, essential proteins like von Willebrand factor remained stable, indicating a promising safety profile.
Area of Science:
- Biochemistry
- Hematology
- Virology
Background:
- Plasma-derived medicinal products require robust virus inactivation methods.
- Photochemical treatment with methylene blue (MB) is a potential strategy for pathogen reduction.
Purpose of the Study:
- To evaluate the efficacy and safety of MB/light treatment for virus inactivation in plasma.
- To assess the impact of MB/light treatment on coagulation factors and other plasma proteins.
Main Methods:
- Utilized the Maco Pharma Maco-Tronic system for MB photochemical treatment.
- Assessed losses of coagulation factors (fibrinogen, FV, FVIII, FIX, FXI) and proteins (vWf, ATIII, protein C).
- Monitored complement activation (C3a, C5a) and coagulation activation markers (prothrombin fragment 1+2, FXIIa) post-filtration.
Main Results:
- MB/light treatment resulted in moderate losses of certain coagulation factors: 23% fibrinogen, 10% FV, 26% FVIII, 11% FIX, and 13% FXI.
- Von Willebrand factor (vWf) multimers and antigen (vWf:Ag), antithrombin III (ATIII), and protein C showed no substantial losses.
- Filtration did not induce activation of complement or coagulation pathways.
Conclusions:
- MB photochemical treatment demonstrates potential for virus inactivation in plasma with acceptable retention of key proteins.
- Further studies are needed to assess treatment in different plasma groups and optimize factor recovery.
