Process for the preparation of pathogen-inactivated RBC concentrates by using PEN110 chemistry: preclinical studies.
BACKGROUND
A pathogen-inactivation process for RBC concentrates is being developed by using PEN110 chemistry (INACTINE, V.I. Technologies). The objective of this study was to characterize the quality of RBCs prepared by using the PEN110 process and to measure the virucidal effect achieved against two viruses.


METHODS
Virology and RBC studies were conducted with standard RBC units treated with 0.1-percent (vol/vol) PEN110 at 22 degrees C for 6 hours. The quality of PEN110-treated human RBCs was assessed with biochemical and phenotypic variables. The in vivo viability of PEN110-treated RBCs in baboons was studied with the double-label (51)Cr/(125)I method.


RESULTS
Decreases in infectious titer by inactivation of greater than a 5 log 50-percent tissue culture infectious doses per mL of bovine viral diarrhea virus (an enveloped RNA virus) and porcine parvovirus (a nonenveloped DNA virus) was observed. RBC hemolysis was less than 1 percent after 42 days of storage, and no changes in RBC antigens were observed. The in vivo viability of PEN110-treated baboon RBCs was unchanged from control.


CONCLUSIONS
The preparation of RBCs by using the PEN110 process achieved a significant viral reduction of two diverse viruses without causing adverse effects to the RBCs. The process appears to be a promising approach, thus justifying further study.
Purmal
Andrei
A
V.I. Technologies, Inc., Watertown, Massachusetts 02472, USA. andrei.purmal@vitechnologies.com
Valeri
C Robert
CR
Dzik
Walter
W
Pivacek
Linda
L
Ragno
Gina
G
Lazo
Aris
A
Chapman
John
J
D019794:2,3-Diphosphoglycerate / Q000097:blood; D000255:Adenosine Triphosphate / Q000097:blood; D000818:Animals; D000954:Antigens, Surface / Q000032:analysis; D001388:Aziridines / Q000737:chemistry; D001782:Blood Donors; D001908:Diarrhea Viruses, Bovine Viral / Q000187:drug effects; D004203:Disinfection; D004905:Erythrocyte Aging; D004912:Erythrocytes / Q000737:chemistry / Q000276:immunology / Q000821:virology*; D006461:Hemolysis; D006801:Humans; D007700:Kinetics; D010215:Papio; D028323:Parvovirus, Porcine / Q000187:drug effects; D011073:Polyamines / Q000737:chemistry* / Q000494:pharmacology; D011188:Potassium / Q000097:blood; D014777:Virus Diseases / Q000517:prevention & control / Q000635:transmission
D000954:Antigens, Surface; D001388:Aziridines; C451719:PEN 110; D011073:Polyamines; D019794:2,3-Diphosphoglycerate; C033132:aziridine; D000255:Adenosine Triphosphate; D011188:Potassium