Mirasol PATHogEn rEDuCTion TECHnologY SYSTEM

Plasma Quality Maintained
Mirasol
®
pathogen reduction technologY SYSTEM
Reduce pathogen load while still providing quality FFP
Mirasol Pathogen Reduction Technology (PRT) is designed to optimize the balance between safety and the efficacy of
your blood products.
Mirasol-treated fresh frozen plasma (FFP) maintains good quality of therapeutic proteins as demonstrated in multiple
external validation studies.1-3
Functional performance of FFP maintained with the Mirasol system
Mirasol-treated FFP meets the Council of Europe guidelines4 for untreated FFP protein quality1-3,5
High levels of coagulation factors have been demonstrated in Mirasol-treated FFP1-3,5,6
Mirasol-treated FFP has been shown to retain qualitative and functional activity of immunoglobulins6
Overall activity measured in external validation studies for Mirasol-treated FFP compared to Council of Europe guidelines
Proteins Measured
CoE Guidelines
14th Edition4
Mirasol-Treated
Avg. (± SD)*
Factor VIIIc (IU/mL)
≥ 0.7, on average
0.8 (± 0.2)
Total Protein (g/L)
≥ 50, on average
53 (± 4)
Protein quality demonstrated under multiple conditions
External validation studies confirmed that functional levels of therapeutic proteins are retained in
Mirasol-treated FFP under varied blood banking conditions. Conditions validated:
Apheresis1 and whole blood-derived plasma2,3
Different anticoagulants, including ACD-A5,6, 4% sodium citrate1, CPD3 and CPDA2
Held for up to 18 hours at 22°C as whole blood and frozen up to 24 hours after collection3
The average retention measured across all coagulant factors in Mirasol-treated FFP was 86 percent.
Proteins Measured
Control Avg
% Retention Avg ± SD*
Total Protein (g/L)
58
100 ± 4
Fibrinogen (IU/mL)
314
72 ± 10
Factor II (IU/mL)
1.2
85 ± 6
Factor V (IU/mL)
1.2
79 ± 7
Factor VIIIc (IU/mL)
1.2
77 ± 11
Factor IX (IU/mL)
1.2
81 ± 10
Factor X (IU/mL)
1.1
83 ± 6
Factor XI (IU/mL)
1.2
68 ± 7
Antithrombin (IU/mL)
1.0
100 ± 6
Protein C (IU/mL)
1.2
91 ± 12
Protein S (IU/mL)
1.1
96 ± 7
a2-antiplasmin (IU/mL)
1.1
95 ± 5
ADAMTS-13 (%NPH)
102
88 ± 22
*SD: standard deviation
Plasma Quality Maintained
Average percent plasma protein retention for coagulants from external validations
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
Total Protein
Fibrinogen
Factor II
Factor V
Factor VIIIc
Factor IX
Factor X
Factor XI
Antithrombin
Protein C
Protein S
α-2 antiplasmin
ADAMTS-13
Quality of Mirasol-treated FFP preserved after extended storage
Mirasol-treated FFP may be stored for up to two years at -30°C5, 6:
Measure*
After 1 year at -30°C
After 2 years at -30°C
Factor VIIIc (IU/mL of plasma)
0.8
0.8
Percent retention of Factor VIIIc compared to
control stored under similar conditions
80%
78%
*Data presented are from a study where previously frozen plasma was thawed and treated and then refrozen for a total storage time of 2 years at -30°C, representing
worst case conditions6
Option to Mirasol-treat previously frozen plasma
FFP that has already been frozen may be thawed and effectively treated with the Mirasol system6:
Removes Many of thetime constraints associated with processing of FFP
Enables remote plasma collections to be processed centrally
Permits pathogen reduction of already frozen plasma in inventory
Learn more: The Mirasol system can help you provide safer blood products today.
Contact your Terumo BCT sales representative or visit terumobct.com for additional information.
References
1.Smith J and G Rock, “Protein Quality in Mirasol Pathogen
Reduction Technology-Treated, Apheresis-Derived Fresh
Frozen Plasma.” Transfusion 2010; 50 (4): 926-931.
2. Hornsey VS, et al., “Pathogen Reduction of Fresh Plasma Using
Riboflavin and Ultraviolet Light: Effects on Plasma Coagulation
Proteins.” Transfusion 2009; 49: 2167-2172.
3. Larrea L, et al., “The Influence of Riboflavin Photochemistry
on Plasma Coagulation Factors.” Transfusion and Apheresis
Science 2009; 41: 199-204.
4. Council of Europe–European Directorate for the Quality of
Medicines and Healthcare (EDQM), Guide to the Preparation,
Use and Quality Assurance of Blood Components, 2008, 14th
ed., Council of Europe, Strasbourg.
5. Bihm DJ, et al., “Characterization of Plasma Protein Activity in
Riboflavin and UV Light-Treated Fresh Frozen Plasma During 2
Years of Storage at -30°C.” Vox Sanguinis 2010; 98: 108-115.
6. Ettinger A, et al., “Protein Stability of Previously Frozen Plasma,
Riboflavin and UV Light-Treated, Refrozen and Stored for up
to 2 Years at -30°C.” Manuscript submitted to Transfusion and
Apheresis Science 2010.
Terumo BCT, Inc.
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