ISBT 2013

PRESENTED AT
23rd Regional Congress of the
International Society of Blood Transfusion
DATE
June 2 - 5, 2013
LOCATION
Amsterdam, The Netherlands
BE SURE.
PROGRAM OF ABSTRACTS
ISBT | June 2 5, 2013 | Amsterdam, The Netherlands
ORAL PRESENTATIONS
Time Title & Authors Page
Monday, June 3rd, 2013, Elicium 1 - Quality of RBC Products
2D-S12-02
16:30 - 16:45
In Vitro Quality Of Red Blood Cells Following Second Generation S-303 Pathogen
Inactivation Treatment
KM Winter, L Johnson, M Kwok et al
5

POSTER PRESENTATIONS
On Display During Exhibition Hours:
RAI Conventions Centre Poster Hall located in the Europa Foyer (Ground oor)
Blood Products - 3.4 Pathogen Inactivation
Poster Walk: Monday evening, June 3rd, 2013 from17:30-18:30
Poster # Title & Authors Page
INTERCEPT Blood System for PLATELETS
P-197
Clinical Efcacy of Platelet Concentrates Treated With the INTERCEPT Blood System
IM Nakastoev, EG Gemdjian, MZ Alexanyan et al
6
P-203
Evaluation of Manual Pooling of 8 Buffy-Coats for Double-Dose Pooled Pathogen-Reduced
Platelet Concentrates
R Norda, M Bergsten, F Knutson
7
P-205
The Functional Properties of Platelets Treated with the INTERCEPT Blood System for
Pathogen Inactivation
IM Nakastoev, EG Gemdjian, NV Zakharova et al
8
P-206
Effect of INTERCEPT Blood System Technology on the Quality of Platelet Concentrates
Experience From Moscow Haematology Research Center
EA Vatagina, IM Nakastoev, MJ Aleksanyan et al
10
Table of Contents
.
4 INTERCEPT Blood System | Program of Abstracts
INTERCEPT Blood System for PLASMA
P-261
Inactivation of Crimean-Congo Hemorrhagic Fever Virus (CCHFV) in Full Units of
Human Plasma Using Amotosalen and UVA
Arslan, A Ozkul, K Dupuis et al
11
P-
Quality of Cryoprecipitate Manufactured from Fresh Frozen Plasma Treated with
Methylene Blue or INTERCEPT Pathogen Inactivation Systems
M Wiltshire, L Backholer, S Proftt et al
12
INTERCEPT Blood System for PLATELETS & PLASMA
P-649
Routine Transfusion Experience in Pediatric Patients Using Platelet and Plasma
Components Treated for Pathogen Inactivation
A Elliott, L Corash
13
INTERCEPT Blood System for RED BLOOD CELLS
P-234
Validation of the S-303 Pathogen Inactivation System for RBC Components
V Brixner, J Leibacher, K Janetzko et al
14
P-236
Qualication of the S-303 Treatment System at Two Italian Blood Centers
M Pani, M Bonaria Tronci, I Loi et al
15
P-251
Quality of Inactivated Red Cells Compared to Gamma Irradiated Red Cells
F Knutson, HL Lof, ET Tennby et al
17
P-262
Screening of Patients for Preexisting Antibodies to Pathogen Inactivated Red Blood Cells
C Geisen, V Brixner, L Stempniewski et al
18
ISBT | June 2 5, 2013 | Amsterdam, The Netherlands
In Vitro Function INTERCEPT Blood System for RED BLOOD CELLS 2D-S12-02
In Vitro Quality of Red Blood Cells Following Second Generation S-303
Pathogen Inactivation Treatment
Kelly M Winter
1
, Lacey Johnson
1
, Matthew Kwok
1
, Diana Vidovic
1
, Ryan Hyland
1
, Nina Mufti
2
, Anna Erickson
2
, Hans Vermeij
3
, Denese C
Marks
1
1. Research and Development, Australian Red Cross Blood Service, Sydney, NSW, Australia; 2. Cerus Corporation, Concord, CA,
United States of America; 3. Cerus BV, Amersfoort, Netherlands
BACKGROUND: Over the past decade there has been a growth in the development of pathogen reduction
technologies to improve the safety of the blood supply and protect against emerging pathogens. This development has
proven challenging for RBCs; however the S-303 treatment system has been shown to be effective against a broad
spectrum of pathogens with minimal damage to RBCs.
AIMS: The aim of this study was to evaluate the in vitro effects of the second generation S- 303 treatment system on
RBCs prepared from whole blood held overnight at room temperature (RT) and stored in SAG-M.
METHODS: Three ABO/RhD-matched, leukocyte-depleted day 1 red cell concentrates (RCCs) in SAG-M were pooled
and split for a three-arm study (n=10). One RCC was subjected to S-303 treatment; the second was stored at RT for
the duration of the S-303 treatment process, and the control RCC was immediately transferred to 26C. The S-303
treatment process included the addition of S-303 (0.2 mM) and glutathione (20 mM) to RBCs for 18 to 20 hours, after
which the by-products of the S-303 treatment process, including the major breakdown product S-300 and GSH, was
removed by centrifugation and RBCs were re-suspended in SAG-M. RCCs were sampled weekly over the 42 day
storage period and tested using in vitro assays to measure red cell quality, metabolism and functional parameters. A
repeated measures analysis of variance using Prism 5 was used for statistical comparisons.
RESULTS: Following S-303 treatment there was a slight decrease in RBC numbers as well as haemoglobin (Hb; 3.8
0.8 g/unit), however these units still met minimum Hb requirements for leukocyte depleted RCCs (40 g/unit). Haemolysis
increased during storage, but remained below 0.8% at day 42 (0.21 0.10 % S-303; 0.30 0.18 % RT; 0.26 0.14
% control), which is the upper limit of acceptance in Australia, with no signicant differences between the three
groups (p=0.5155). The glucose consumption rate was signicantly different between S-303 treated, RT and control
groups (p=0.0039), with both S-303 treated and RT RCCs having reduced consumption compared to control RCCs.
Consequently, S-303 treated RCCs also had a signicantly lower lactate concentration and pH compared to the paired
controls over the storage period (p=0.0091 and p<0.0001, respectively). Despite potassium concentrations being lower
in S-303 treated RCCs compared to the RT and control RCCs throughout storage, the potassium release rate was
consistent in all three groups (p=0.7144). RCCs were depleted of 2,3-DPG after S-303 treatment, however this was also
observed in the untreated RCCs stored at RT, suggesting that the observed reduction in 2,3-DPG concentrations was
likely due to RT storage rather than the S-303 treatment per se. No changes in RBC receptors (CD235a) were observed
due to treatment or storage.
CONCLUSIONS: RCCs treated with the second generation S-303 system for pathogen inactivation had similar in
vitro properties to paired control RCCs currently produced by standard blood banking conditions in Australia. Quality
parameters of S-303 treated products were within the Australian and New Zealand Society for Blood Transfusion
guidelines
ORAL
6 INTERCEPT Blood System | Program of Abstracts
Clinical Studies P-197 INTERCEPT Blood System for PLATELETS
Clinical Efcacy of Platelet Concentrates Treated with the INTERCEPT
Blood System
Islam M. Nakastoev, Eduard G. Gemdjian, Mikhail Zh. Alexanyan, Vladimir M. Gorodetsky
National Research Center for Hematology, Moscow, Russia
BACKGROUND: Blood transfusion still is a possible source of disease transmission. Even though the safety of the
blood supply continues to improve and we manage to control some of the known threats, new challenges will continue
to arrive. Careful donor selection, vigilant screening, and continuous efforts to develop new techniques for screening
and pathogen inactivation will be required to keep blood products, and thus blood transfusions, safe.
AIM: The purpose of the study was to assess the impact of pathogen inactivation (PI) of platelet concentrates (PC) on
the post-transfusional platelet counts and hemostatic support. The transfusion interval was also assessed.
MATERIALS AND METHODS: This prospective study included 29 patients with hematological malignancies (13
female, 16 male), with a median age of 38 years (20-66). Most transfusions (43 of 58). in both groups were prophylactic
Apheresis platelets in 100% plasma were used in this study. The platelets were 24 h old. Indications for transfusion
were determined by the attending physician in accordance to routine clinical practice. PI was performed using the
amotosalen/UVA-based INTERCEPT Blood System, (IBS, Cerus Corporation, Concord, CA, USA). Each patient
received two platelet transfusions: one transfusion with pathogen inactivated PC and a conventional transfusion.
The endpoints were 1-h CI, 24-h CI and transfusion interval. Bleeding was assessed in accordance to the WHO
classication 1 hour prior to transfusion. Bleeding was considered resolved when spontaneous bleeding was stopped
and/or when no new hemorrhages were observed in 1 and 24 hours after transfusion.
RESULTS: Analysis of post-transfusion count increments showed a slight decrease for the pathogen inactivated PC
when compared with conventional (Table 1). Clinical efcacy was assessed by comparing corrected count increment
(CCI) to normal values. According to previously published data, acceptable values for CCI-1h is above 7.5-10 x 10
9
/L
and for CCI-24h at least 4.5-7 x 10
9
/L. Thus, pathogen inactivated PC gave values of CCI within the acceptable range.
Analyses of the interval between transfusions remained virtually unchanged, with a mean interval of 3.4 and 3, 5 days
respectively(Table 1).
In the cohorts of patients receiving PI platelets or conventional platelets 7 and 8 patients respectively had Grade 1
bleeding (petechiae) before the transfusion. All patients had relief of hemorrhagic syndrome and effective prevention of
new hemorrhage regardless of the pathogen inactivation.
CONCLUSION: PI with the INTERCEPT Blood system has no impact on the clinical efcacy functionality of platelets.
The lower counts determined post-transfusion for pathogen inactivated PC which were still within normal range, did
not lead to increased demand for transfusions. Clinical efcacy of platelets treated with INTERCEPT shows comparable
data to conventional platelets.
Table1. The Effectiveness of Transfusions with PI Platelet Concentrates Compared with Transfusion of
Conventional Ones
Conventional PC
(n = 29)
INTERCEPT PC
(n = 29)
Number of transfused platelets (x 10
11
) 3,9 3,7
1 h - CI (x 10
9
/L) 33,24 7,49 25,17 7,53
24 h - CI (x 10
9
/L) 21,59 6,26 15,27 8,25
1 h - CCI (x 10
9
/L) 15,01 3,48 11,61 3,14
24 h - CCI (x 10
9
/L) 9,76 2,9 7,05 3,98
Transfusion interval (days) 3,45 3,31
POSTER
ISBT | June 2 5, 2013 | Amsterdam, The Netherlands
Implementation INTERCEPT Blood System for PLATELETS P-203
Evaluation of Manual Pooling of 8 Buffy-Coats for Double-Dose Pooled
Pathogen-Reduced Platelet Concentrates
Rut Norda
1
, M Bergsten
2
, F Knutson
3

1. Akademiska sjukhuset, Uppsala, Sweden; 2. Vstmanalands sjukhus Vsters, Vsters, Sweden; 3. Akademiska sjukhuset, Uppsala,
Sweden
BACKGROUND: In Vstmanland in the Uppsala-region, Sweden, the production of pathogen-reduced platelet
concentrates was started in 2011 after requests by clinicians of the County Hospital. The same principle and technique
as in Uppsala was applied: double-doses and Amotosalen-UVA irradiation (INTERCEPT). In contrast to the automated
process for the production of platelet units in Uppsala, the manual procedure was adapted to prepare the new
component. The aim was to have pathogen-reduced, leukocyte-reduced platelet units of > 240 x 10
9
platelets per unit.
The leukocyte-reduction lter of the container for the pool was not previously validated for our application for 8 BC, but
for seven (7). We present data on the leukocyte content in platelet components from our Component Quality Control
(QC) Program.
MATERIAL AND METHODS: Eight buffy-coats (BC) were used after an overnight rest on a platelet agitator at 20-24
C. They were pooled with the addition of 300 ml SSP
+
in a two-step train fashion using an Octopus Fenwal R7039
System. The bag, holding approx. 570-620 mL was rested 15 min before centrifugation. The Optipress program for the
previous (ve-BC) protocol was used for the bag. The platelet concentrate was passed through the lter of the R7039
system and air expressed. The INTERCEPT system was attached by sterile docking and after the pathogen reduction
process had been successfully completed the double-doses was nally divided in two units for transfusion.
RESULTS: During the period 28 Nov 2011 till February 6 2013, a total number of 1295 platelet units were produced. The
average platelet content was 264 31 x 10
9
per unit and 77% were above the requested limit. In total, 184 units were
submitted for QC, which is 14% of the total production during the period. Seven (7) batches of pooling sets were used.
The leukocyte content was 0.102 0,237 x 10
6
/L and 0.02 0.048 x 10
6
Lpk per unit. All (100%) of the units had a
leukocyte content that were below the limit of 1 x 10
6
Lpk per unit.
CONCLUSION: The manual process was implemented and proved to be feasible. The new application for passing eight
BCs through the lter, attached to the Fenwal R7039 pooling bag, has been validated successfully.
POSTER
8 INTERCEPT Blood System | Program of Abstracts
# INTERCEPT Blood System for BLOOD PRODUCT Cerus Category In Vitro Function P-205 INTERCEPT Blood System for PLATELETS
The Functional Properties of Platelets Treated with the INTERCEPT Blood System
for Pathogen Inactivation
Islam M. Nakastoev, Eduard G. Gemdjian, N. V. Zakharova, E. A. Vatagina, M. Zh. Alexanyan, Vladimir M. Gorodetsky
National Research Center for Hematology, Moscow, Russia
BACKGROUND: Platelet concentrates (PCs) are widely used to support patients who receive myeloablative therapies
for hematologic malignancies and solid tumors. With an increased number of transfusions of PC, the increased risk for
bacterial contamination makes it desirable to adopt pathogen inactivation (PI) technologies.
AIM: Platelets undergo a number of events during collection, processing, and storage that adversely affect their
structure and function, resulting in reduced post transfusion recovery. The aim of this study was to understand how
pathogen inactivation inuences the functional properties of the platelets.
METHODS: In this study, 46 platelet concentrates were harvested with the MCS plus (Haemonetics, Braintree, MA,
USA) and prepared in 100% plasma. Each PC was split into three units. Each replicate consisted of a Control Unit (C)
and two test units (T), one of which were only stored for 20-24 h (T1) and one was in addition pathogen inactivated (T2).
PI was performed using the amotosalen/UVA-based INTERCEPT Blood System, (IBS, Cerus Corporation, Concord,
CA, USA). All samples were collected in compliance with sterile conditions in a volume of 5 1 ml.
Platelet count and size were measured by cell counters and with the Sysmex XE-21000 device (Kobe, JP). The platelets
with a size of more than 12 fL (P-LCR) and the immature platelet fractions (IPF) were identied on the basis of their
uorescence intensity using special software (XE IPF MASTER). P-LCR and IPF are expressed as a proportional value
(%) of the total optical platelet count In addition, the surface expression of phosphatidylserine (PS) and P-selectin with
and without activation by collagen-related peptide (CRP) were also quantied. The number of PS-positive platelets was
analyzed by ow cytometry using uorescently labeled annexin V. P-selectin expression was investigated in the same
FACS assay using uorescence labeled CD62P mabs.
RESULTS: Pathogen inactivation in PC has an impact on the platelet concentration irrespectively of the type of platelets
(mature/immature), (Table 1).
Expression of PS and P-selectin were higher in the unit stored for 20-24 prior to PI. This indicates that slight activation
of platelets occurred during the storage. Meanwhile, PI suppressed the spontaneous platelet activation (Table 2). After
the CRP-activation the P-selectin-positive platelets in all samples increased to the same level. Additionally, the level of
PS-positive platelets after activation was found to be about 2-fold decreased in the pathogen inactivated PCs
CONCLUSION: Pathogen inactivated PC treated with INTERCEPT shows a statistically signicant but small decrease
in platelet count. A suppression of spontaneous platelet activation is observed during storage. High expression
of P-selectin in platelet activated with CRP indicates intact platelet activation. Several studies indicate that PS
expressions on platelets does not serve as a marker of apoptosis but are involved in the formation of pro-coagulant
platelet membrane. Furthermore, clinical trials have demonstrated that suppression of PS expression in pathogen
inactivated platelets, after activation of CRP does not reduce the clinical efcacy of transfusions. Additional studies
on aggregation activity where performed. These results show that INTERCEPT treated platelets showed normal
aggregation activity with three inducers (collagen, ristosetin, ADP).
Table 1. The Number and Content of Large and Immature PCs
Parameter
Units
Control (C)
Stored PCs 20-24h
(T1)
Stored PCs 20-24h +
INTERCEPT (T2)
Concentration (x 10
9
/L) 1138,0 63,0* 1008,3 58,4* 946,7 58,4*
P-LCR (%) 16,0 6,6 13,7 5,9 12,9 6,3
IPF (%) 1,5 1,65 1,45
* Statistically signicant differences between any two values (p <0,05)
Continued
POSTER POSTER
ISBT | June 2 5, 2013 | Amsterdam, The Netherlands
# INTERCEPT Blood System for BLOOD PRODUCT Cerus Category In Vitro Function INTERCEPT Blood System for PLATELETS P-205 Cont.
Table 2. Indicators of Platelet Functionality in the PCs
Parameter (%)
Units
Control (C)
Stored PCs 20-24h
(T1)
Stored PCs 20-24h
INTERCEPT (T2)
Expression of PS
Background 4,1 1,4 9,5 5,6* 4,1 2,1
After activation with CRP 29,5 10,3 30,1 1,2 15,4 9,6**
Expression of
P selectin
Backgound 10, 4,3 22,3 12,3* 13,3 6,8
After activation with CRP 79,7 8,5 77,4 9,6 78,2 15,2
* Statistically signicant difference compared with the samples number 2 (p <0,05)
** Statistically signicant differences in comparison with the samples No1,2 (p <0,05)
POSTER
10 INTERCEPT Blood System | Program of Abstracts
# INTERCEPT Blood System for BLOOD PRODUCT Cerus Category
Effect of INTERCEPT Blood System Technology on the Quality of Platelet
Concentrates Experience From Moscow Haematology Research Center
EA Vatagina, IM Nakastoev, MJ Aleksanyan, VM Gorodetsky
National Research Center for Hematology, Moscow, Russia
BACKGROUND: The Moscow Hematology Research Center provides around 7000-8000 therapeutic doses of platelet
concentrates (PC) annually. Blood transfusions are an important part of hematologic care. Transfusions have long
been associated with some risk to patients and thus the safety of blood components continues to be an important
issue. Bacterial contamination of blood products, particularly of platelets continues to be the most important threat.
An effective approach to prevent the transmission of blood-borne infections is to use pathogen inactivation technique,
without affecting the quality of transfused platelets.
AIM: The aim was to examine the qualitative and quantitative parameters of the INTERCEPT treated PC.
MATERIAL AND METHODS: In this study, 12 apheresis platelet concentrates were harvested with the MCS plus
(Haemonetics, Braintree, MA, USA) and prepared in 100% plasma. Each PC was split into three units. Each replicate
consisted of a Control Unit (C) and two test units (T), one of which were only stored for 20-24 h (T1) and one was in
addition pathogen inactivated (T2). PI was performed using the amotosalen/UVA-based INTERCEPT Blood System,
(IBS, Cerus Corporation, Concord, CA, USA). All samples were collected in compliance with sterile conditions in a
volume of 4 0.5 ml. The platelet concentration ranged between 200-400 x 109/L. Platelet aggregation was studied
with an aggregometer from NPF BIOLA 230LA (Russia) using three agonists - ADP, collagen and ristocetin.
RESULTS: The aggregation study with collagen and ristocetin showed normal levels of aggregation in all the samples
with no statistically signicant changes (Table 1).
Interesting data were obtained from the ADP-induced aggregation study. In Control unit the ADP induced aggregation
were around 66%, meanwhile during the storage for 20-24 h (T1) the level of aggregation decreased to an average of
20%. In the pathogen inactivated test unit (T2) platelet aggregation was on average 42% (Table 1). The results show
that PI platelets had signicantly higher aggregation with ADP than only stored platelets.
CONCLUSION: Pathogen inactivation had no negative effect on platelet aggregation with collagen and ristocetin.
Platelets subjected to PI with INTERCEPT Technology, demonstrate better performance of ADP-induced aggregation
compared with platelets stored for 20-24 h, but not exposed to PI. It is well known, that during PC storage, a
spontaneous activation of platelets occurs under the inuence of endogenous ADP, which is released by the platelets.
This results in a decreased sensitivity to ADP receptors on the platelets. As a result, during pathogen inactivation of
platelets using INTERCEPT technology a spontaneous suppression of platelet activation occurs, resulting in PC with
more sensitivity towards ADP receptors. Transfused, pathogen inactivated PC were shown to be clinically efcacious.
No reactions associated with transfusion pathogen inactivated PCs were reported as well as no markers of viral or
bacterial infections were reported.
Table 1: Results on the Aggregation of Platelets
Units
Agonist
Control (C)
(n = 12)
Stored PCs 20-24h (T1)
(n = 12)
Stored PCs 20-24h +
INTERCEPT (T2)
(n = 12)
ADP (%) 66 16 20 12 42 26
Collagen (%) 68 18 80 20 72 17
Ristocetin(%) 90 13 95 12 93 11
In Vitro Function INTERCEPT Blood System for PLATELETS P-206 POSTER POSTER
ISBT | June 2 5, 2013 | Amsterdam, The Netherlands
INTERCEPT Blood System for BLOOD PRODUCT Cerus Category P-261 INTERCEPT Blood System for PLASMA Inactivation
Inactivation of Crimean-Congo Hemorrhagic Fever Virus (CCHFV) in Full Units of
Human Plasma Using Amotosalen and UVA
nder Arslan
1
, Aykut Ozkul
1
, Kent Dupuis
2
, Fikret Sahin
1
, Adonis Stassinopoulos
2
1. Ankara University, Ankara, Turkey; 2. Cerus Corporation, Concord, California
BACKGROUND: CCHFV (Bunyaviridae, genus Nairovirus) causes outbreaks of severe hemorrhagic fever in humans,
with case-fatality rates of 3-30%. It is the second most widespread of all medically important arboviruses, after
dengue, and belongs to the same family as the one causing Severe Fever with Thrombocytopenia Syndrome (SFTS).
CCHFV cases have been reported throughout broad regions of Africa, Europe, the Middle East, and Asia. Reports
have linked transmission of the virus with ticks of the genus Hyalomma. Transmission of CCHFV to humans occurs
through tick bites, direct contact with blood or tissues of infected animals, person to person spread, or by nosocomial
infection. Since only 1 out of 5 persons infected develops fever and there is a 4 day window before symptoms appear,
transmission of CCHFV through blood transfusion is possible.
The virus consists of 100 enveloped particles. Like inuenza viruses (Orthomyxoviridae) and LCMV (Arenaviridae),
CCHFV has a segmented genome, in this case 3 RNA strands with lengths of 12kb, 5.6kb and 1.2kb, which facilitates
genetic re-assortment and might provide a means to escape inactivation if the treatment is insufciently robust.
The INTERCEPT Blood System (IBS) for pathogen inactivation (PI) has been shown to inactivate high titers of a broad
spectrum of viruses, bacteria, parasites and leukocytes in platelet and plasma components. PI is achieved through
a photochemical process (150 M amotosalen and 3 J/cm
2
low energy ultraviolet-A light). The IBS system prevents
replication of contaminating pathogens by specically targeting and covalently crosslinking nucleic acids without
affecting the safety and efcacy of the treated products.
AIMS: Evaluate the inactivation of CCHFV, the rst Bunyavirus to date, in full units of human plasma.
METHODS: Jumbo plasma units were generated (~600 mL, N=4) by pooling three WB derived plasma units, and
determined to be free of CCHFV antibodies. They were then inoculated with 1/10 volume of cell-free CCHFV (~ 4 log
TCID
50
/mL). The plasma units were subsequently illuminated using a commercial device and disposables. Samples
were taken pre- and post-illumination to determine input titer and residual viable virus, respectively. The samples
were serially diluted, inoculated onto Vero E6 cells (0.2 mL; 6 or 10 wells per dilution for pre and post-PCT testing,
respectively) and incubated for 3 days. Infected wells were visualized by incubation with mouse polyclonal anti-CCHFV
antibody, followed by incubation with FITC-conjugated anti-mouse IgG. Wells were considered positive, if uorescent.
RESULTS: The virus was inactivated to the limit of detection (LOD), limited by the concentration of the available stock
and labeling reagents. No positive cells were observed for any dilutions for the post-treatment samples, while all
dilutions but the lowest were positive for the pre samples.
CONCLUSION: CCHFV can be inactivated to the LOD, in full units of plasma under standard Blood Center operations.
CCHFV Inactivation in Plasma (n=4)
TCID
50
Titers (Mean SD)
Pre-UVA Post-UVA
a
Log Reduction
3.6 0.1 <0.7 0.0 >2.9 0.1
a
Below LOD
POSTER POSTER
12 INTERCEPT Blood System | Program of Abstracts
P- In Vitro Function INTERCEPT Blood System for PLASMA
Quality of Cryoprecipitate Manufactured from Fresh Frozen Plasma Treated with
Methylene Blue or INTERCEPT Pathogen Inactivation Systems
M Wiltshire, L Backholer, S Proftt, and R Cardigan
NHSBT, Brentwood, Essex, UK
BACKGROUND: Cryoprecipitate, which is manufactured from fresh frozen plasma (FFP), is used in the treatment of
patients with acquired brinogen deciency. Pathogen inactivation (PI) systems for the treatment of plasma have been
developed to inactivate a broad range of pathogens, but are known to reduce the activity of a range of coagulation
factors including brinogen. Little data are available comparing cryoprecipitate produced from PI plasma from different
systems.
AIMS: To investigate the effects of MB/light (Theraex) and amotosalen/UVA (INTERCEPT) PI systems on the quality of
cryoprecipitate.
METHODS: Plasma manufactured from whole blood held overnight at ambient temperature was pooled to produce
identical units of plasma for each arm of the study (8 group A and 8 group O in each arm). Pools were split into
individual units and rapidly frozen to produce FFP. Units of FFP were treated as follows: A) thawed, treated with MB
and refrozen within 2 hours B) thawed, 2 units pooled (as a double volume is required for treatment), treated with
INTERCEPT, split and refrozen within 2 hours; and control units C) thawed, held at room temperature for 1-2 hours and
refrozen. For equivalence, INTERCEPT treated units were transferred into bags comprising PVC incorporating DEHP
plasticiser (VSE4001XB, Macopharma) prior to freezing. Treated and control FFP were slowly thawed at 4 C and the
supernatant removed. Cryoprecipitate was then rapidly frozen. Samples of FFP (before and after treatment) along with
cryoprecipitate were tested for Factor VIII (FVIII) and brinogen by clotting assays using an ACL TOP 500 coagulometer.
RESULTS: The volume of the units of plasma prior to treatment was approximately 260ml. The loss of FVIII due to PI
treatment of plasma was within expected limits (20.3 4.3% for MB and 25.4 5.2% for INTERCEPT) as was the loss
of brinogen (35.1 5.0% for MB and 26.8 4.5% for INTERCEPT).

A: MB B: INTERCEPT C: Control
FVIII
IU/Unit
61.5*
(7.8)
57.3*
(8.0)
83.8
(10.6)
% of units >50 IU 93.3 87.5 n/a
Fibrinogen
mg/U
219.2*
(20.6)
251.0*
(45.0)
383.3
(42.6)
% of units >140mg 100 100 n/a
Data shown as mean SD, n=16. * Values are signicantly lower than Control data p<0.001
CONCLUSIONS: Cryoprecipitate manufactured from FFP PI treated using either system met the current UK
specication for FVIII and brinogen content of PI cryoprecipitate (>75 % of units >50 IU and 140 mg per unit
respectively). PI treated units, as expected, contain lower levels of both FVIII and brinogen than those made from
untreated plasma.
POSTER
ISBT | June 2 5, 2013 | Amsterdam, The Netherlands
P-649 Hemovigilance INTERCEPT Blood System for PLATELETS AND PLASMA
Routine Transfusion Experience in Pediatric Patients Using Platelet and Plasma
Components Treated for Pathogen Inactivation
Anne Elliott, Laurence Corash
Cerus Corporation, Concord, California, USA
BACKGROUND: Pediatric patients are at increased risk for transfusion-transmitted infection (TTI) due to immature
immune systems. Pathogen inactivation (PI) of platelet and plasma components can help prevent TTI and benet
this population. Enrollment of pediatric patients in clinical trials is challenging due to the relative infrequent need for
transfusion in this population. Post-market hemovigilance (HV) studies provide an opportunity to evaluate the use and
response to transfusion in this population.
AIMS: A multi-center active HV program was utilized to gain experience with transfusion of PI platelet and plasma
components to pediatric patients.
METHODS: Twenty two study centers in 11 countries enrolled patients in 4 active HV studies for patients transfused
with platelet and plasma components treated for PI with amotosalen and UVA light [INTERCEPT Blood System
(IBS), Cerus Corporation, Concord, CA]. Participating centers were required to collect demographic data and record
the response to all IBS transfusions regardless of outcome. Adverse events were collected for 24 hours after each
transfusion and serious adverse events within 7 days after transfusion. IBS was used in place of bacterial detection,
gamma irradiation and CMV serology in most of these centers. The primary outcome measures included exposure to
IBS components and the frequency of transfusion reactions (TR) dened as an AE possibly, probably or related to the
transfusion. The treating physicians assigned the relationship of AE to the transfusion.
RESULTS:1,039 pediatric patients received 1,143 IBS platelet components and 3,179 IBS plasma components. 499
patients were infants (age <1 year) and 540 patients were children (age 1-18 years). Primary clinical indications for
transfusion included general medical conditions (45%), hematology-oncology disorders (34%), and surgical (20%).
Children had more exposure than infants. 12 children and no infants experienced a TR. By sign/symptom the relative
descending frequency of events were: pruritus/urticaria/rash, fever/chills, tachycardia, dyspnea and facial swelling. No
serious TR, TRALI or transfusion-related sepsis were reported for pediatric patients.
SUMMARY/CONCLUSIONS: The predominant use of IBS plasma in pediatric patients was to support general medical
disorders and the predominant use of IBS platelets was to support hematology-oncology disorders. Transfusion of
IBS platelet and plasma components in pediatric patients was well tolerated with only low-grade reactions and TR
commonly associated with conventional products.
IBS Platelet and Plasma Recipients Pediatric Patients
Infants (< 1 year) Children (1 18 year) All Pediatric Patients
Platelets Plasma Platelets Plasma Platelets Plasma Total
Indication
General Medical 50 211 55 156 105 367 472
Hematological Disease 5 122 120 108 125 230 355
Surgery 4 107 10 91 14 198 212
Total Pediatric Patients 59 440 185 355 244 795 1039
Adverse Events 0 0 13 3 13 3 16
Transfusion Reactions 0 0 9 3 9 3 12
Total IBS Components 113 1125 1030 2054 1143 3179 4322
Mean Number of
Components/Patient
1.9 2.6 5.6 5.8 4.7 4.0 4.2
POSTER
14 INTERCEPT Blood System | Program of Abstracts
P-234 In Vitro Function INTERCEPT Blood System for RED BLOOD CELLS
Validation of the S-303 Pathogen Inactivation System for RBC Components
Veronika Brixner
1
, Johannes Leibacher
1
, Karin Janetzko
2
, Herv Isola
3
, Michel Laforet
3
, Jean-Pierre Cazenave
3
, Anna Erickson
4
, Nina
Mufti
4
1. DRK Frankfurt, Germany; 2. DRK Mannheim, Germany; 3. EFS-Alsace, Strasbourg, France; 4. Cerus Corporation, Concord, CA, USA
BACKGROUND: The INTERCEPT System for Red Blood Cells (RBCs) was developed to inactivate pathogens and
leukocytes in RBC components for transfusion. The Second Generation System uses S-303 to crosslink nucleic acids,
preventing replication of contaminating pathogens and residual leukocytes. Glutathione (GSH) is included to quench
non-specic reactions. A Phase 3 clinical trial in elective cardiovascular surgery patients with acute anemia is in
preclinical development in Europe. The primary endpoint of the study, hemoglobin content per RBC unit, will assess the
suitability of the INTERCEPT System to process S-303 treated RBCs and support patients requiring RBC transfusions.
AIMS: These studies were designed to demonstrate that S-303 treated RBCs meet the criteria for conventional
leukocyte-depleted RBCs in additive solution as dened by the Council of Europe (EDQM, 16th Ed.). These studies
were performed at two blood centers, the Etablissement Franais du Sang (EFS) in Strasbourg, France and the
Deutsches Rotes Kreuz Blutspendedienst (DRK) in Frankfurt, Germany.
METHODS: 65 CPD whole blood donations were held at room temperature (RT) for up to 24 hours, then centrifuged
and separated into buffy coat, plasma, and leukocyte-depleted SAGM RBCs. Within 48 hours of collection, each
RBC unit was treated with the S-303 process; GSH and RBCs were added to a custom diluent followed by S-303
addition (20mM GSH/0.2mM S-303, based on 280mL RBC input). After an 18-24h RT hold, units were centrifuged; the
treatment solution was expressed using the Optipress II (EFS) or manually (DRK) and replaced with SAG-M. RBCs were
stored at 42C for 5 weeks, sampled on D2 or D3 and between D35 and D38 (Table 1) and assessed for quality control
criteria.
RESULTS: At EFS the input volume was 262-318 mL and 260-330 mL at DRK. The post S-303 treatment mean and SD
for volume, hemoglobin (Hb), hematocrit (Hct), and day 35 hemolysis are listed in Table 1. The volume post treatment
was 234-304 mL at EFS, with a loss of 2.0 2.5 g of Hb due to the S-303 process (n=30). The nal volume at DRK was
240-314 mL with a loss of 2.8 1.0 g of Hb (n=35). All units had Hb values of 40g ranging from 40-66 g. The nal Hct
was 51-61% across both sites, within the 50-70% criterion. After 35 to 38 days of storage, the mean hemolysis was
0.25 0.1%with all units <0.8%.
CONCLUSIONS: Mean values for 65 units of S-303 treated RBC units were >40g Hb, Hct within 50-70% and hemolysis
<0.8% after 35 days of storage. RBC treated with the Second Generation S-303 Treatment System met the EDQM 16th
Ed. guidelines for leukocyte-depleted RBCs in additive solution with respect to leukocytes, Hct, Hb, and hemolysis.
Table 1. Quality Control Parameters (MeanSD, Min-Max)
Parameter
EFS-Alsace
(n=30)
DRK-Frankfurt
(n=35)
Requirements
Units meeting
requirement (%)
Volume
(mL)
270 16 273 17
180-330 mL
a
100%
234 - 304 240 - 314
Hemoglobin per unit
(g)
51 5 53 6
> 40 g/unit
b
100%
42 - 59 40 - 66
Hematocrit
(%)
56 2 57 2
50-70%
b
100%
53 - 60 51- 61
Hemolysis after 35
days of storage (%)
0.3 0.1 0.2 0.1
<0.8% of red cell
mass
b
100%
0.2 - 0.4 0.1 - 0.7
Quality control data for conventional leukocyte-depleted RBCs in additive solution meet the <1X10
6
residual leukocytes per unit
a
Dened for the S-303 Treatment System based on an input of 220-340 mL of leukocyte depleted RBCs in SAG-M
b
Criteria for conventional leukocyte-depleted RBCs in additive solution as dened by the Council of Europe (EDQM 16th Ed.)
POSTER
ISBT | June 2 5, 2013 | Amsterdam, The Netherlands
In Vitro Function INTERCEPT Blood System for RED BLOOD CELLS P-236
Qualication of the S-303 Treatment System at Two Italian Blood Centers
Mario Pani
1
, Maria Bonaria Tronci
1
, Irene Loi
1
, Anna Maria Bordiga
2
, Luciana Labanca
2
, Graziella Lucania
2
, Fabio Pinesich
3
, Betsy
Donnelly
4
1. Azienda Ospedaliera Brotzu, Cagliari, Italy; 2. Blood Component and Production Center, AO Citt della Salute e della Scienza di
Torino, Italy; 3. Cerus BV, Amersfoort, Netherlands; 4. Cerus Corporation, Concord, CA, USA
BACKGROUND: A Phase 3 clinical trial in patients with thalassemia major requiring chronic RBC transfusion support
is in preclinical development in Italy to evaluate the safety and efcacy of S-303 treated RBCs using the INTERCEPT
System for Red Blood Cells (RBCs) compared to conventional RBCs. The INTERCEPT System is intended to inactivate
pathogens and leukocytes in RBC components for transfusion by using S-303 to crosslink nucleic acids, preventing
replication of contaminating pathogens and residual leukocytes.
AIMS: Studies were designed to qualify blood centers to process study RBC components and validate the S-303
treatment process for the planned Phase 3 clinical trial.
METHODS: On the day (D) of collection, D-0, leukocyte-depleted SAG-M RBCs were prepared from CPD whole blood
donations and stored at 42C. For the qualication studies, ABO matched pairs of leukocyte-depleted SAG-M RBC
were combined and split on D-1. One unit per replicate was placed at 42C (Control; Site #1-18247mL and Site #2-
26528mL) and the other was treated with the S-303 process (Test; Site #1-26115mL and Site #2-2811mL). Test
RBCs were added to a diluent containing GSH followed by S-303 addition (nal concentrations of 20mM GSH/0.2mM
S-303, based on 280mL RBC input). After 18-24 hours RT hold, RBCs were centrifuged and the treatment solution was
expressed and replaced with SAG-M. For the validation studies all units were treated on D-1 with the S-303 process.
RBCs were stored at 42C for 35 days; qualication units were sampled for testing on D2, D7, D21 and D35 (Table 1)
and validation units were sampled post treatment and on D35 (Table 2).
RESULTS: Qualication Studies: After treatment all Test units had Hct of 50-70% and Hb 40g. Extracellular protein
was 5-7 fold lower in Test units compared to Control. On Day 35 K+, lactate and pH were signicantly lower in Test
compared to Control. Hemolysis was <0.8% and ATP values were > 2mol/ g Hb for all units on Day 35 (Table 1).
VALIDATION STUDIES: The volume post treatment was 230-289mL at Site #1, with a loss of 2.40.5g of Hb due to
the S-303 process (n=14). The nal volume at Site #2 was 231-306mL with a loss of 2.10.5g of Hb (n=12). The post
S-303 treatment mean and SD for volume, Hb, Hct, and hemolysis are listed in Table 2. All units had Hb values of
40g ranging from 41-66g. The nal Hct was 52-61% across both sites, within the 50-70% criterion. After treatment,
hemolysis ranged from 0.0-0.3% for all units; D35 hemolysis was 0.1-0.6% at Site #1, <0.8% (Table 2).
CONCLUSIONS: The S-303 Treatment System was successfully transferred to two blood centers in Italy and the in
vitro quality of S-303 treated RBCs was comparable to conventional RBCs. Validation studies demonstrated that all
S-303 treated RBC units met the EU guidelines for leukocyte depleted RBCs in additive solution with respect to Hct, Hb
content and hemolysis at end of storage.
Table 1. Qualication Studies: In Vitro Quality after 35 days of Storage
Site #1 (n=6) Site #2 (n=6)
Test Control Test Control
Hematocrit (Hct, %)
a
56.8 3.2 58.4 1.3 58.0 0.8 58.8 1.8
Hemolysis (%) 0.26 0.06 0.29 0.15 0.18 0.5 0.22 0.13
Extracellular Potassium (K
+
, mM) 38.8 1.9 42.4 2.7
b
45.8 3.0 51.1 3.7
b
Extracellular lactate (mM) 26.0 4.3 35.3 8.3
b
23.2 4.8 31.9 1.1
b
Extracellular Sodium (Na
+
, mM) 117 2 116 3 104 2 102 2
b
pH at 37C 6.6 0.1 6.8 0.1
b
6.35 0.02 6.46 0.02
b
Extracellular glucose (mM) 17.3 3.1 16.6 4.4 17.9 0.6 16.3 0.9
b
Total ATP (mol/g Hb) 3.02 0.76 2.82 0.30 4.02 0.31 3.24 0.19
b
a
D2
b
paired students t-test at D35 p-value <0.05
Continued
POSTER
16 INTERCEPT Blood System | Program of Abstracts
# INTERCEPT Blood System for BLOOD PRODUCT Cerus Category In Vitro Function INTERCEPT Blood System for RED BLOOD CELLS P-236 Cont.
Table 2. Validation Studies: Quality Control Parameters (MeanSD, Min-Max)
Parameter Site #1 (n=14) Site #2 (n=12)
Quality Control
Criteria
Units meeting
requirement (%)
Volume
(mL)
a
254 17 264 20
190-330 mL 100%
230 - 289 231 - 306
Hemoglobin
per unit (g)
45.9 4.6 54.1 5.9
40 g/unit 100%
41.4 - 55.5 44.6 - 66.1
Hematocrit
(%)
55.5 2.6 56.4 2.3
50-70% 100%
51.7 - 59.9 51.8 - 60.7
Hemolysis at D2
0.14 0.06 0.09 0.04
<0.3% of red cell
mass
100%
0.04 - 0.26 0.04 - 0.14
Hemolysis at the
end of storage
0.32 0.15
-
<0.8% of red cell
mass
100%
0.11 - 0.62
a
Dened for the S-303 Treatment System based on an input of 220-340 mL of leukocyte depleted RBCs in SAG-M and inclusive of input and
nal product sampling
POSTER
ISBT | June 2 5, 2013 | Amsterdam, The Netherlands
# INTERCEPT Blood System for BLOOD PRODUCT Cerus Category P-251 In Vitro Function INTERCEPT Blood System for RED BLOOD CELLS
Quality of Inactivated Red Cells Compared to Gamma Irradiated Red Cells
F Knutson
1
, HL Lof
1
, ET Tennby
2
, BD Donnelly
3
, MAS Schott
3
, AE Erickson
3
, NM Mufti
3
1. Uppsala University, Uppsala, Sweden; 2. Cerus BV, Amersfoort, Netherlands; 3. Cerus Corporation, Concord, United States of
America
BACKGROUND: The INTERCEPT System for Red Blood Cells (RBCs) has been developed to inactivate pathogens and
leukocytes in RBC components for transfusion. S-303 is used to crosslink nucleic acids and thereby prevent replication.
Glutathione (GSH) is included to quench non-specic reactions. Previous studies using the rst generation system
demonstrated >5 log of leukocyte inactivation and recent studies with the second generation S-303 treatment system
have shown comparable in vitro quality to conventional, non-gamma irradiated RBCs.
AIMS: The objective of this study was to assess the in vitro quality of S-303 treated RBCs and compare it to gamma
irradiated RBCs stored for up to 42 days.
METHODS: 450 mL CPD whole blood (WB) units were separated into plasma, buffy coat and SAG-M RBC after being
held on cooling plates for a minimum of 2 hours post collection. For each replicate, ABO matched pairs of leukocyte-
depleted SAG-M RBC were combined and split into units of 2847 mL (n=11).
On Day (D) 0 one unit per replicate was placed at 4C and the other was treated with the S-303 Treatment System for
RBCs (S-303 RBC). RBCs were added to a diluent containing GSH followed by S-303 addition (nal concentrations
of 20mM GSH/0.2mM S-303, based on 280mL RBC input). After a 200.1 hours hold at 21-23C S-303 RBCs were
centrifuged and the treatment solution was expressed and replaced with SAG-M. On D1, the second unit of each
replicate was exposed to 25 Gy of gamma irradiation (IR RBC). The units were sampled for in vitro analyses on D1, 14,
28, 35 and 42 days of storage.
RESULTS: Post S-303 process, the Hb content of S-303 RBC was 452 g and spun Hct was 58 1%, while IR RBC
had 52 3 g and 59 1%, respectively. Extracellular protein was reduced 7-fold in S-303 RBC (26 7mg/dL) compared
to IR RBC (193 33 mg/dL). On D14 the 2,3 DPG levels in IR RBC was signicantly higher than those in S-303 RBC
(2.43 0.74 vs. 0.21 0.14 mol/g Hb; p<0.0001).
On D28, the expiration for IR RBC, S-303 RBC had signicantly higher ATP, Na
+
, and MCHC and signicantly lower
hemolysis, pH, plasma free Hb, K
+
, lactate and MCV. These signicant differences are consistent over 42 days of
storage.
S-303 RBC had signicantly less red cell microvesicles on D28 than IR RBC (1565 1856 vs. 3716 2775 vesicles/L;
p=0.017). RBC deformability was reduced in S-303 RBC compared to IR RBC on Day 28 (elongation index at 30Pa was
0.582 0.011 for S-303 RBC vs. 0.594 0.007 for IR RBC; p=.005).
CONCLUSIONS: S-303 treated RBCs had improved in vitro quality compared to gamma-irradiated RBCs with respect
to potassium leakage and hemolysis post processing throughout the storage period while containing less plasma
protein. S-303 treated RBCs have similar quality to conventional RBCs with the added benet of being pathogen and
leukocyte inactivated. The S-303 Treatment System may provide an alternative to gamma irradiation for the prevention
of leukocyte-mediated transfusion reactions with an extended shelf-life.
Day 28 Day 42
S-303 RBC IR RBC S-303 RBC IR RBC
% Hemolysis 0.17 0.07 0.68 0.13
a
0.2 0.1 1.1 0.1
b
pH at 37C 6.429 0.026 6.517 0.019
a
6.340 0.017 6.414 0.027
b
Total ATP (mol/g Hb) 4.778 78 0.73574 4.064 0.540
a
3.200 0.51752 2.523 0.343
b
Plasma free haemoglobin (mol/L) 39 15 188 41
a
52 19 292 54
b
Extracellular Potassium (K
+
; mmol/L) 38.8 2.6 68.7 2.3
a
49.5 2.5 71.7 1.9
b
Extracellular Sodium (Na
+
; mmol/L) 118.4 2.2 90.9 1.7
a
109.8 2.7 89.5 1.8
b
Extracellular Glucose (mmol/L) 18.8 0.8 18.9 0.9 16.1 1.0 15.4 1.1
Extracellular Lactate (mmol/L) 22.1 1.3 30.9 1.6
a
25.4 1.1 36.8 1.8
b
MCV (fL) 91 2 95 2
a
91 2 98 3
b
MCHC (g/dL) 33.6 0.5 31.5 0.5
a
34.2 0.9 31.2 0.4
b
a
p<0.05; paired t-test at Day 28
b
p<0.05; repeated measure ANOVA including Days 1, 7, 14, 28, 35, and 42
POSTER
18 INTERCEPT Blood System | Program of Abstracts
# INTERCEPT Blood System for BLOOD PRODUCT Cerus Category P-262 Inactivation INTERCEPT Blood System for RED BLOOD CELLS
Screening of Patients for Preexisting Antibodies to Pathogen Inactivated Red Blood
Cells
C Geisen
1
, V Brixner
1
, L Stempniewski
1
, A North
2
, N Mufti
2
, E Seifried
1
1. Institute of Transfusion Medicine and Immunohaematology, Johann Wolfgang Goethe University, DRK Blood Donor Service Baden
Wrttemberg-Hessen; 2. Cerus Corporation, Concord, CA, USA
BACKGROUND: In preparation for a Phase 3 clinical trial using the S-303 Treatment System for pathogen inactivation
of red blood cell components (RBCs) for transfusion of acute anemia patients, we screened 2315 patients in a large
university hospital for pre-existing immune reactivity to S-303 treated RBCs. Prior experience with the rst generation
S-303 Treatment System had shown that there was a small proportion of patients (1 to 2%) with pre-existing antibodies
against the acridine moiety of S-303 that was associated with S-303 treated RBCs. Six hundred of the patients
screened were undergoing cardiovascular surgery, the patient population to be evaluated in the Phase 3 clinical trial.
AIMS: This study was designed to evaluate the prevalence of immune reactivity to S-303 treated RBCs in the planned
clinical study cohort using the second generation S-303 treatment system that results in a reduced number of S-303
adducts per RBC.
METHODS: RBC of a voluntary blood group O blood donor were split into three parts and pathogen inactivated using
1) rst generation PI method (high S-303 adducts) 2) second generation PI method (low S-303 adducts) and 3) not
pathogen inactivated. RBC were frozen in Glycerolyte (Fenwal) and stored at -80C until day of antibody screening
using a gel card centrifugation technique (BioRad).
Patient samples were either stored at 4C or centrifuged and plasma was frozen at -30C within 48h after blood
drawing. For screening purposes, 25 l of each patient sample was incubated with 50 l of 0.8% erythrocyte
suspension and Liss/Coombs sera on DiaMed Gel Cards using a Tecan Liquid handling machine. After 15 min of
incubation at 37C gel cards were centrifuged and checked for positive reactions using Saxo Reader (Biorad). A positive
control of monoclonal antibody to S-303 was included for each run.
RESULTS: We analysed our potential study cohort for epidemiologic parameters and found this patient cohort to be
of average age of 67 years (1 day to 99 years old) and to have a male / female ratio of 57% to 43%. In one patient,
immune reactivity to S-303 treated RBCs was detected and conrmed by inhibition of agglutination with an S-303
analogue, S-300. Further characterization revealed a warm reactive acridine-specic IgG-antibody with a titer of 4
against RBC with high acridine (rst generation PI method). Reaction against low acridine cells (second generation PI
method) was only weakly positive. The patient is a 73 year old male of Arabic descent undergoing arterial valve repair
surgery. In all other patients acridine specic antibodies were excluded.
CONCLUSIONS: The prevalence of immune reactivity to S-303 treated RBCs using the second generation S-303
treatment process is expected to be a rare event. Further studies are needed to reveal the prevalence of immune
reactivity and acridine specic antibodies to S-303 treated RBCs in various patient cohorts.
POSTER
customer_services@cerus.com
www.interceptbloodsystem.com
www.cerus.com
Global Headquarters
Cerus Corporation
2550 Stanwell Drive
Concord, CA 94520, USA
+1 925 288 6000
European Headquarters
Cerus Europe B.V.
Stationsstraat 79-D
3811 MH Amersfoort
The Netherlands
+31 33 496 0600

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Use of INTERCEPT is contraindicated in patients
with a history of allergic response to amotosalen
or psoralens. No pathogen inactivation system
has been shown to inactivate all pathogens.
Not approved for sale in the U.S.
INTERCEPT REGULATORY APPROVALS
CE mark, Class III
2002 (platelets)
2006 (plasma)
France (ANSM)
2003 (platelets)
2006 (plasma)
Germany (PEI)
2007* (platelets)
2011* (plasma)
Switzerland (Swissmedic)
2009 (platelets)
2010 (plasma)
* First blood center marketing authorization approved.