Chemical apparatus and process disinfecting – deodorizing – preser – Process disinfecting – preserving – deodorizing – or sterilizing – Using disinfecting or sterilizing substance
Patent
1997-09-12
1999-04-06
Henley, III, Raymond
Chemical apparatus and process disinfecting, deodorizing, preser
Process disinfecting, preserving, deodorizing, or sterilizing
Using disinfecting or sterilizing substance
A61L 900
Patent
active
058913939
DESCRIPTION:
BRIEF SUMMARY
RELATED APPLICATIONS
This application is a 371 of international application PCT/US96/05018, filed Apr. 19, 1996.
FIELD OF THE INVENTION
The present invention relates to methods of preparing fixed-dried blood platelets suitable for administration to human patients, wherein microbial decontamination of the platelets is achieved during preparation thereof.
BACKGROUND OF THE INVENTION
The use of platelet concentrates in transfusion medicine has become well established during the past thirty years. However, the rapid loss of platelet function during the storage period and risk of bacterial contamination has greatly complicated management of an effective inventory of platelet concentrates in blood banks. In many settings, the limited shelf life of platelet concentrates has drastically reduced their usage.
E. Klein et al., J. Pediatrics 49, 517-522 (1956), describe the preparation and administration of lyophilized platelet material to children with acute leukemia and aplastic anemia. Pain and venospasm at the site of infusion were noted. The limited effectiveness of these materials is shown in Table 2 therein. After more than thirty years, these materials have not led to a useful therapeutic treatment.
In order to make platelet transfusion therapy more manageable for blood banks, there has been considerable interest in devising means for diminishing or delaying the loss of platelet function during the storage period. One approach has been in the context of the development of plasma-free storage media. See, e.g., S. Holme, U.S. Pat. No. 4,695,460. Another approach has been to employ biochemical techniques to stabilize the platelets. See, e.g., A. Bode et al., U.S. Pat. No. 4,994,367. While these techniques provide useful extension of shelf life, they do not provide a shelf life extended for prolonged periods of time. Finally, the preparation of platelet membrane microvesicles from, among other things, outdated platelets is described in F. Chao, U.S. Pat. No. 5,185,160.
Fixed-dried blood platelets for use in diagnostic assays are disclosed in U.S. Pat. No. 4,287,087 to Brinkhous et al. While such fixed-dried platelet preparations can be stored for prolonged periods of time for diagnostic purposes, they have not heretofore been provided in a form for human pharmaceutical use. Accordingly, there is a continuing need for new means of preparing blood platelet preparations having prolonged shelf lives which are suitable for administration to human patients.
M. Read et al., PCT Application WO93/23997 (published 9 Dec. 1993), describes fixed-dried blood platelets and processes for preparing the same.
SUMMARY OF THE INVENTION
A method for inactivating microbiological contaminants in a human blood platelet preparation is disclosed. The method comprises, first, providing blood platelets, particularly human blood platelets, suspected of being contaminated with microorganisms (e.g., bacteria, viruses). The platelets are then contacted to a fixative for a time sufficient to fix the platelets, and then (preferably) washed and dried to produce fixed-dried blood platelets. The step of contacting the platelets to a fixative is carried out for a time sufficient to kill some or all of the contaminating microorganisms. However, the contacting step is carried out for a time insufficient to cause the platelets to lose the capability, upon drying and reconstitution, to: surface; thrombogenic surface; and treatment.
The foregoing and other objects and aspects of the present invention are explained in detail in the specification set forth hereinbelow.
DETAILED DESCRIPTION OF THE INVENTION
In the preparation of blood-derived biopharmaceuticals, it is desirable for the processes involved to either remove or inactivate (i.e., kill) at least several log cycles of microbial infectivity. Whether a partial killing of microorganisms (e.g., a bactericidal or viricidal processes) or a total killing of microorganisms (e.g., a sterilizing process) such inactivation provides some assurance that adventitious agents, including contaminants t
REFERENCES:
patent: 4287087 (1981-09-01), Brinkhous et al.
patent: 5026543 (1991-06-01), Rijke
patent: 5281392 (1994-01-01), Rubinstein
Bode Arthur P.
Read Marjorie S.
Summaria Louis J.
Armour Pharmaceutical
East Carolina University
Henley III Raymond
The University of North Carolina at Chapel Hill
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