Estimating the pathogen safety of manufactured human plasma products: application to fibrin sealants and to thrombin
Identifieur interne : 000393 ( Istex/Curation ); précédent : 000392; suivant : 000394Estimating the pathogen safety of manufactured human plasma products: application to fibrin sealants and to thrombin
Auteurs : Bernard Horowitz [États-Unis] ; Michael Busch [États-Unis]Source :
- Transfusion [ 0041-1132 ] ; 2008-08.
English descriptors
- Teeft :
- Analytic sensitivity, Antibody seroconversion, Assay, August, Baxter, Baxter process, Blood banks, Blood products, Blood supply, Blood transfusion, Bovine, Bovine spongiform agent, Bovine thrombin, Brin, Brin sealant, Brin sealant products, Brin sealants, Brinogen, Brinogen component, Busch, Canine parvovirus, Cell line, Chikungunya virus, Chronic infection, Chronic stages, Clearance capacity, Clearance factors, Clinical studies, Coagulation factor, Dengue viruses, Derivative, Donation, Donor, Donor unit, Drug administration, Epidemiologic evidence, Factor viii, Fibrinogen, Fractionation pool, Growth hormone, Heat cycle, Heat sensitivity, Heat treatment methods, Hepatitis, Higher number, Horowitz, Human parvovirus, Human plasma, Human plasma products, Human thrombin, Human virus, Immune, Immune globulin, Immunoglobulin, Inactivation, Infectious agent, Infectious disease markers, Infectious units, Infectious virus, Infectivity, Intravenous immunoglobulin, Kleinman, Labile blood components, Lower number, Manufacturing pools, Manufacturing procedures, Manufacturing process, Maximum genomic load, Maximum load, Medicinal products, Minipool format, Monoclonal antibodies, Mouse minute virus, Neutralization capacity, Neutralizing antibodies, Nonenveloped viruses, Nucleic acid testing, Omrix, Operational sensitivity, Other donors, Other hand, Other steps, Parvovirus, Parvovirus antibody, Parvovirus transmission, Past decade, Pasteurization, Pathogen, Pathogen safety, Pathogen safety table, Pathogen transmission, Plasma, Plasma derivatives, Plasma donors, Plasma fractionation, Plasma fractionators, Plasma pool, Plasma pools, Plasma products, Positive samples, Positive units, Prion, Pseudorabies virus, Recombinant, Regulatory authorities, Reserve capacity, Residual risk, Safety margin, Safety margins, Safety record, Screening procedures, Sealant, Source plasma donors, Spongiform, Sufficient antibody, Surgical exposure, Thermal inactivation, Thorac surg, Thrombin, Thrombin component, Time point, Transfusion, Transfusion medicine, Transfusion volume, Transmissible spongiform encephalopathy, Vaccinia virus, Vapor heating, Vcjd, Vial, Viii, Viral, Viral elimination, Viral inactivation, Viral infections, Viral load, Viral loads, Viral safety, Viral threats, Viremia, Virion particles, Virus, Virus inactivation, Virus inactivation steps removal steps, West nile virus, Whole blood, Window period.
Abstract
BACKGROUND: Plasma fractionators have implemented many improvements over the past decade directed toward reducing the likelihood of pathogen transmission by purified blood products, yet little has been published attempting to assess the overall impact of these improvements on the probability of safety of the final product. STUDY DESIGN AND METHODS: Safety margins for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), hepatitis A virus (HAV), parvovirus B19, and variant form of Creutzfeldt‐Jakob disease (vCJD) were calculated for the two fibrin sealants licensed in the United States and for thrombin. These products were selected because their use in a clinical setting is, in most cases, optional, and both were relatively recently approved for marketing by the US Food and Drug Administration (FDA). Moreover, thrombin and fibrinogen both undergo two dedicated virus inactivation steps and/or removal steps in accord with the recommendations of regulatory agencies worldwide. Safety margins were determined by comparing the potential maximum viral loads in contaminated units to viral clearance factors, ultimately leading to the calculation of the residual risk per vial. RESULTS: The residual risk of pathogen transmission per vial was calculated to be less than 1 in 10−15 for HIV, HCV, HBV, and HAV for both fibrinogen and thrombin. Owing to the greater quantities that can be present and its greater thermal stability, the calculated risk for parvovirus transmission was 1 in 500,000 vials for fibrinogen and less than 1 in 107 per vial for thrombin. Assuming that vCJD is found to be present in plasma donations, its risk of transmission by these purified and processed plasma derivatives would appear to be very low. CONCLUSIONS: The pathogen safety initiatives implemented by plasma fractionators over the past 10 to 20 years have resulted in products with excellent pathogen safety profiles. Of the agents examined, parvovirus continues to have the lowest calculated margin of safety. Despite this, parvovirus transmissions should be rare. Manufacturers are encouraged to continue exploring processes to further enlarge parvovirus safety margins and to continue exploring ways of eliminating prions.
Url:
DOI: 10.1111/j.1537-2995.2008.01717.x
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ISTEX:967B0DC576018C0F3558D8E9C862640DDE948A3BLe document en format XML
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<profileDesc><textClass><keywords scheme="Teeft" xml:lang="en"><term>Analytic sensitivity</term>
<term>Antibody seroconversion</term>
<term>Assay</term>
<term>August</term>
<term>Baxter</term>
<term>Baxter process</term>
<term>Blood banks</term>
<term>Blood products</term>
<term>Blood supply</term>
<term>Blood transfusion</term>
<term>Bovine</term>
<term>Bovine spongiform agent</term>
<term>Bovine thrombin</term>
<term>Brin</term>
<term>Brin sealant</term>
<term>Brin sealant products</term>
<term>Brin sealants</term>
<term>Brinogen</term>
<term>Brinogen component</term>
<term>Busch</term>
<term>Canine parvovirus</term>
<term>Cell line</term>
<term>Chikungunya virus</term>
<term>Chronic infection</term>
<term>Chronic stages</term>
<term>Clearance capacity</term>
<term>Clearance factors</term>
<term>Clinical studies</term>
<term>Coagulation factor</term>
<term>Dengue viruses</term>
<term>Derivative</term>
<term>Donation</term>
<term>Donor</term>
<term>Donor unit</term>
<term>Drug administration</term>
<term>Epidemiologic evidence</term>
<term>Factor viii</term>
<term>Fibrinogen</term>
<term>Fractionation pool</term>
<term>Growth hormone</term>
<term>Heat cycle</term>
<term>Heat sensitivity</term>
<term>Heat treatment methods</term>
<term>Hepatitis</term>
<term>Higher number</term>
<term>Horowitz</term>
<term>Human parvovirus</term>
<term>Human plasma</term>
<term>Human plasma products</term>
<term>Human thrombin</term>
<term>Human virus</term>
<term>Immune</term>
<term>Immune globulin</term>
<term>Immunoglobulin</term>
<term>Inactivation</term>
<term>Infectious agent</term>
<term>Infectious disease markers</term>
<term>Infectious units</term>
<term>Infectious virus</term>
<term>Infectivity</term>
<term>Intravenous immunoglobulin</term>
<term>Kleinman</term>
<term>Labile blood components</term>
<term>Lower number</term>
<term>Manufacturing pools</term>
<term>Manufacturing procedures</term>
<term>Manufacturing process</term>
<term>Maximum genomic load</term>
<term>Maximum load</term>
<term>Medicinal products</term>
<term>Minipool format</term>
<term>Monoclonal antibodies</term>
<term>Mouse minute virus</term>
<term>Neutralization capacity</term>
<term>Neutralizing antibodies</term>
<term>Nonenveloped viruses</term>
<term>Nucleic acid testing</term>
<term>Omrix</term>
<term>Operational sensitivity</term>
<term>Other donors</term>
<term>Other hand</term>
<term>Other steps</term>
<term>Parvovirus</term>
<term>Parvovirus antibody</term>
<term>Parvovirus transmission</term>
<term>Past decade</term>
<term>Pasteurization</term>
<term>Pathogen</term>
<term>Pathogen safety</term>
<term>Pathogen safety table</term>
<term>Pathogen transmission</term>
<term>Plasma</term>
<term>Plasma derivatives</term>
<term>Plasma donors</term>
<term>Plasma fractionation</term>
<term>Plasma fractionators</term>
<term>Plasma pool</term>
<term>Plasma pools</term>
<term>Plasma products</term>
<term>Positive samples</term>
<term>Positive units</term>
<term>Prion</term>
<term>Pseudorabies virus</term>
<term>Recombinant</term>
<term>Regulatory authorities</term>
<term>Reserve capacity</term>
<term>Residual risk</term>
<term>Safety margin</term>
<term>Safety margins</term>
<term>Safety record</term>
<term>Screening procedures</term>
<term>Sealant</term>
<term>Source plasma donors</term>
<term>Spongiform</term>
<term>Sufficient antibody</term>
<term>Surgical exposure</term>
<term>Thermal inactivation</term>
<term>Thorac surg</term>
<term>Thrombin</term>
<term>Thrombin component</term>
<term>Time point</term>
<term>Transfusion</term>
<term>Transfusion medicine</term>
<term>Transfusion volume</term>
<term>Transmissible spongiform encephalopathy</term>
<term>Vaccinia virus</term>
<term>Vapor heating</term>
<term>Vcjd</term>
<term>Vial</term>
<term>Viii</term>
<term>Viral</term>
<term>Viral elimination</term>
<term>Viral inactivation</term>
<term>Viral infections</term>
<term>Viral load</term>
<term>Viral loads</term>
<term>Viral safety</term>
<term>Viral threats</term>
<term>Viremia</term>
<term>Virion particles</term>
<term>Virus</term>
<term>Virus inactivation</term>
<term>Virus inactivation steps removal steps</term>
<term>West nile virus</term>
<term>Whole blood</term>
<term>Window period</term>
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<front><div type="abstract" xml:lang="en">BACKGROUND: Plasma fractionators have implemented many improvements over the past decade directed toward reducing the likelihood of pathogen transmission by purified blood products, yet little has been published attempting to assess the overall impact of these improvements on the probability of safety of the final product. STUDY DESIGN AND METHODS: Safety margins for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), hepatitis A virus (HAV), parvovirus B19, and variant form of Creutzfeldt‐Jakob disease (vCJD) were calculated for the two fibrin sealants licensed in the United States and for thrombin. These products were selected because their use in a clinical setting is, in most cases, optional, and both were relatively recently approved for marketing by the US Food and Drug Administration (FDA). Moreover, thrombin and fibrinogen both undergo two dedicated virus inactivation steps and/or removal steps in accord with the recommendations of regulatory agencies worldwide. Safety margins were determined by comparing the potential maximum viral loads in contaminated units to viral clearance factors, ultimately leading to the calculation of the residual risk per vial. RESULTS: The residual risk of pathogen transmission per vial was calculated to be less than 1 in 10−15 for HIV, HCV, HBV, and HAV for both fibrinogen and thrombin. Owing to the greater quantities that can be present and its greater thermal stability, the calculated risk for parvovirus transmission was 1 in 500,000 vials for fibrinogen and less than 1 in 107 per vial for thrombin. Assuming that vCJD is found to be present in plasma donations, its risk of transmission by these purified and processed plasma derivatives would appear to be very low. CONCLUSIONS: The pathogen safety initiatives implemented by plasma fractionators over the past 10 to 20 years have resulted in products with excellent pathogen safety profiles. Of the agents examined, parvovirus continues to have the lowest calculated margin of safety. Despite this, parvovirus transmissions should be rare. Manufacturers are encouraged to continue exploring processes to further enlarge parvovirus safety margins and to continue exploring ways of eliminating prions.</div>
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