In vitro evaluation of COM.TEC apheresis platelet concentrates using a preparation set and pathogen inactivation over a storage period of five days

2004 ◽  
Vol 19 (4) ◽  
pp. 185-191 ◽  
Author(s):  
R. Moog ◽  
A. Fröhlich ◽  
V. Mayaudon ◽  
L. Lin
Keyword(s):  
Storage Period ◽  
Pathogen Inactivation ◽  
Platelet Concentrates ◽  
In Vitro Evaluation

Pharmacokinetic and toxicology assessment of INTERCEPT (S-59 and UVA treated) platelets

2001 ◽  
Vol 20 (10) ◽  
pp. 533-550 ◽  
Author(s):  
V Ciaravino ◽  
T McCullough ◽  
A D Dayan
Keyword(s):  
Ex Vivo ◽  
Reproductive Toxicity ◽  
In Vivo Studies ◽  
Pathogen Inactivation ◽  
Platelet Concentrates ◽  
Baxter Healthcare ◽  
Safety Margins ◽  
Toxicology Assessment

The pathogen inactivation process developed by Cerus and Baxter Healthcare Corporations uses the psoralen, S-59 (amotosalen) in an ex vivo photochemical treatment (PCT) process to inactivate viruses, bacteria, protozoans, and leukocytes in platelet concentrates and plasma. Studies were performed by intravenous infusion of S-59 PCT formulations-compound adsorption device (CAD) treatment and with non-UVA illuminated S-59, using doses that were multiples of potential clinical exposures. The studies comprised full pharmacokinetic, single and repeated-dose (up to 13 weeks duration) toxicity, safety pharmacology (CNS, renal, and cardiovascular), reproductive toxicity, genotoxicity, carcinogenicity testing in the p53- mouse, vein irritation, and phototoxicity. No specific target organ toxicity (clinical or histopathological), reproductive toxicity, or carcinogenicity was observed. S-59 and/or PCT formulations demonstrated CNS, ECG, and phototoxicity only at supraclinical doses. Based on the extremely large safety margins (>30,000 fold expected clinical exposures), the CNS and ECG observations are not considered to have any toxicological relevance. Additionally, after a complete assessment, mutagenicity and phototoxicity results are not considered relevant for the proposed use of INTERCEPT platelets. Thus, the results of an extensive series of in vitro and in vivo studies have not demonstrated any toxicologically relevant effects of platelet concentrates prepared by the INTERCEPT system.

In vitro Evaluation of Buffy-Coat-Derived Platelet Concentrates Stored in a Synthetic Medium

Vox Sanguinis ◽  
1991 ◽  
Vol 60 (1) ◽  
pp. 16-22 ◽  
Author(s):  
R. Fijnheer ◽  
H.A. Veldman ◽  
A.J.M. Eertwegh ◽  
C.W.N. Gouwerok ◽  
C.H.E. Homburg ◽  
...  
Keyword(s):  
Synthetic Medium ◽  
Buffy Coat ◽  
Platelet Concentrates ◽  
In Vitro Evaluation

In vitro evaluation of platelet concentrates, prepared from pooled buffy coats, stored for 8 days after filtration

Transfusion ◽  
1994 ◽  
Vol 34 (4) ◽  
pp. 311-316 ◽  
Author(s):  
MN Boomgaard ◽  
AM Joustra-Dijkhuis ◽  
CW Gouwerok ◽  
I Steneker ◽  
HW Reesink ◽  
...  
Keyword(s):  
Platelet Concentrates ◽  
In Vitro Evaluation

scholarly journals Effects of use of riboflavin and ultraviolet light for pathogen inactivation on quality of platelet concentrates

2011 ◽  
Vol 68 (6) ◽  
pp. 489-494 ◽  
Author(s):  
Zoran Stanojkovic ◽  
Ana Antic ◽  
Miodrag Stojanovic
Keyword(s):  
Uv Light ◽  
Storage Period ◽  
Buffy Coat ◽  
Blood Products ◽  
Pathogen Inactivation ◽  
Platelet Concentrates ◽  
Platelet Storage ◽  
Control Units ◽  
The Moment ◽  
Uv Rays

Background/Aim. Pathogen inactivation in blood and blood products is one of the major means to achieve a zero risk blood supply and improve transfusion safety. Riboflavin (vitamin B2) activated by ultraviolet (UV) light, produces active oxygen which damages cell membrane and prevents replication of the carrier of diseases (viruses, bacteria, protozoa) in all blood products. The aim of this study was to establish the influence of the process of pathogens photoinactivation using riboflavin and UV rays on the biochemical and functional characteristics of platelet concentrates prepared from ?buffy coat?. Methods. The examination included 80 platelet concentrates prepared from ?buffy coat?, which was separated from whole blood donated by voluntary blood donors around 6 hours from the moment of collection. Concentrates were pooled, filtered and separated unton two groups: one consisted of 10 control units and the other of 10 examined units (pooled platelet concentrates). Examined units of the platelets were treated by riboflavin (35 mL) and UV rays (6.24 J/mL, 265-370 nm) on Mirasol aparature (Caridian BCT Biotechnologies, USA) in approximate duration of 6 min. A total of 35 mL of saline solution was added to the control units. The samples for examining were taken from the control and examined units initially (K0, I0), after the addition of saline (K1) and riboflavin (I1), after illumination (I2), first day of storage (K3, I3) and the fifth day of storage (K4, I4). The following parameters were measured: platelet count and platelet yield, residual erythrocyte and leukocyte count, pH, pO2, pCO2 and bacterial contamination. Results. All the measured parameters showed a statistically significant decrease comparing to K0 and I0; all the results of the first day of platelet storage showed statistically significant decrease comparing to K1 and I1, and all the results of the fifth day of platelet storage (K4, I4) showed a statistically significant decrease comparing to K1 and K3 and to I1 and I3. There was no the mentioned difference in the measured parameters between K4 and I4 (the end of storage - the fifth day). All the platelet units were sterile till the seventh day, when the investigation ended. Conclusion. Platelet concentrates inactivated by riboflavin and UV rays (Mirasol PRT sistem, Caridian BCT, USA) keep all the characteristics assessed by the Guide to the preparation, use and quality assurance of blood components (Council of Europe), during the whole storage period (five days). The obtained data were correlated with existing up to date literature and demonstrated that Mirasol treated platelets were safe and could be incorporated effectively in the routine blood bank and transfusion setting.

YS05 In Vitro Evaluation of Platelet Concentrates Prepared Using the Automated Gambro OrbiSac System

2006 ◽  
Vol 16 (s1) ◽  
pp. 17-18
Author(s):  
M. Wiltshire ◽  
S. Bashir ◽  
M. Beard ◽  
P. Cookson ◽  
M. Garwood ◽  
...  
Keyword(s):  
Platelet Concentrates ◽  
In Vitro Evaluation

In vitro evaluation of prestorage pools consisting of mixed A and O platelet concentrates

Transfusion ◽  
2007 ◽  
Vol 47 (7) ◽  
pp. 1154-1161 ◽  
Author(s):  
Joseph Sweeney ◽  
Nicola Kouttab ◽  
Stein Holme ◽  
Tracey Cheves ◽  
Ed Nelson
Keyword(s):  
Platelet Concentrates ◽  
In Vitro Evaluation
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