Enhanced virus safety of a solvent/detergent-treated antihemophilic factor IX concentrate by dry-heat treatment

Shin, Jeong Sup; Choi, Yong Whan; Sung, Hark Mo; Ryu, Yeon‐Woo; Kim, In Seop

doi:10.1007/bf02931863

Cited by 4 publications

(5 citation statements)

References 20 publications

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“…As part of the virus validation protocol, cytotoxicity and interference tests were performed as previously described . Cytotoxicity tests were performed on samples generated for virus titration in the virus spiking experiments to control for any possible cytotoxic effects on indicator cells that would interfere with virus titration.…”

Section: Methodsmentioning

confidence: 99%

Pathogen inactivation efficacy of Mirasol PRT System and Intercept Blood System for non‐leucoreduced platelet‐rich plasma‐derived platelets suspended in plasma

et al. 2014

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Section: Methodsmentioning

confidence: 99%

Pathogen inactivation efficacy of Mirasol PRT System and Intercept Blood System for non‐leucoreduced platelet‐rich plasma‐derived platelets suspended in plasma

et al. 2014

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“…Samples were collected at each step, immediately titrated using a 50% tissue culture infectious dose (TCID 50 ), 8 and the virus reduction factors were evaluated. As a part of the virus validation protocol, cytotoxicity, interference, and load titer testing were also performed as reported previously 9,10 …”

Section: Methodsmentioning

confidence: 99%

“…As a part of the virus validation protocol, cytotoxicity, interference, and load titer testing were also performed as reported previously. 9,10…”

Section: Validation Of Viral Inactivation In the Manufacturing Processmentioning

confidence: 99%

Healing of a porcine burn wound dressed with human and bovine amniotic membranes

Park

Kim

et al. 2008

Wound Repair Regeneration

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The effects of amniotic membranes (AMs), either fresh human and bovine AMs or acellular bovine AMs, on wound healing were compared among the burn wounds of porcine skin. Six pigs were chosen for the study, and we created deep second-degree contact burns on them with a digitally controlled aluminum thermal block. Then we applied the dressings to some of the wounds using fresh human and bovine AMs, acellular bovine AMs, polyurethane foam, or no dressing. We evaluated the pigs for (1) the rate of epithelialization, (2) histological grading, and (3) infections. We found that the AM groups showed better wound-healing effects than did the polyurethane foam and no dressing groups, and these differences were statistically significant. However, the differences between the AM groups were not statistically significant. Wound cultures showed higher infection rates in the control and polyurethane foam groups compared with the other groups. Our study showed that fresh or acellular bovine AMs provided similar efficacy for wound healing as did the fresh human AMs.

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“…Virus log reduction factor was defined as log 10 of the ratio of virus loads in the spiked starting and post process materials, as described in a previous report [15]. All virus inactivation experiments were carried out in duplicate and mean values are given.…”

Section: Calculation Of Virus Reduction Factorsmentioning

confidence: 99%

“…Although S/D treated blood products have become widely available over the last 15 years, this treatment generally has no effect on non-enveloped viruses [9][10][11]. Consequently, systems capable of removing and/or inactivating nonenveloped viruses, such as hepatitis A virus (HAV) and human parvovirus B19 (B19), are receiving particular attention from those in the blood industry [12][13][14][15][16].…”

Section: Introductionmentioning

confidence: 99%

Removal and inactivation of viruses during the manufacture of a high-purity antihemophilic factor IX from human plasma

Kim

Bae

Sung

et al. 2009

Biotechnol Bioproc E

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The purpose of this study was to evaluate the efficacy and mechanisms of the solvent/detergent (S/D) treatment, DEAE-toyopearl 650M anion-exchange column chromatography, heparin-sepharose 6FF affinity column chromatography, and Viresolve NFP filtration steps employed in the manufacture of high-purity antihemophilic factor IX (GreenNine VF) from human plasma, with regard to removal and/or inactivation of blood-borne viruses. A variety of experimental model viruses for human pathogenic viruses, including human immunodeficiency virus (HIV), bovine herpes virus (BHV), bovine viral diarrhoea virus (BVDV), hepatitis A virus (HAV), murine encephalomyocarditis virus (EMCV), and porcine parvovirus (PPV), were all selected for this study. Samples from relevant stages of the production process were spiked with each virus and subjected to scale-down processes mimicking the manufacture of high-purity factor IX. Samples were collected at each step, immediately titrated using a 50% tissue culture infectious dose (TCID 50 ), and virus reduction factors were evaluated. S/D treatment using the organic solvent, tri (n-butyl) phosphate (TNBP), and the detergent, Tween 80, was a robust and effective step in inactivation of enveloped viruses. Titers of HIV, BHV, and BVDV were reduced from the initial titer of 6.06, 7.72, and 6.92 log 10 TCID 50 , respectively, reaching undetectable levels within 1 min of S/D treatment. DEAE-toyopearl 650M anion-exchange column chromatography was found to be a moderately effective step in the removal of HAV, EMCV, and PPV with log reduction factors of 1.12, 2.67, and 1.38, respectively. Heparin-sepharose 6FF affinity column chromatography was also moderately effective for partitioning BHV, BVDV, HAV, EMCV, and PPV with log reduction factors of 1.55, 1.35, 1.08, 1.19, and 1.61, respectively. The Viresolve NFP filtration step was a robust and effective step in removing all viruses tested, since HIV, BHV, BVDV, HAV, EMCV, and PPV were completely removed during the filtration step with log reduction factors of ≥ 5.51, ≥ 5.76, ≥ 5.18, ≥ 5.34, ≥ 6.13, and ≥ 4.28, respectively. Cumulative log reduction factors of HIV, BHV, BVDV, HAV, EMCV, and PPV were ≥ 10.52, ≥ 12.07, ≥ 10.49, ≥ 7.54, ≥ 9.99, and ≥ 7.24, respectively. These results indicate that the production process for GreenNine VF has a sufficient virus reduction capacity for achievement of a high margin of virus safety. © KSBB hÉóïçêÇëW=~åíáÜÉãçéÜáäáÅ=Ñ~Åíçê=fuI=îáê~ä=áå~Åíáî~íáçå=~åÇLçê=êÉãçî~äI=äçÖ=êÉÇìÅíáçå=Ñ~ÅíçêI=îáêìë=ë~ÑÉíó= = = = =

show abstract

Enhanced virus safety of a solvent/detergent-treated antihemophilic factor IX concentrate by dry-heat treatment

Cited by 4 publications

References 20 publications

Pathogen inactivation efficacy of Mirasol PRT System and Intercept Blood System for non‐leucoreduced platelet‐rich plasma‐derived platelets suspended in plasma

Pathogen inactivation efficacy of Mirasol PRT System and Intercept Blood System for non‐leucoreduced platelet‐rich plasma‐derived platelets suspended in plasma

Healing of a porcine burn wound dressed with human and bovine amniotic membranes

Removal and inactivation of viruses during the manufacture of a high-purity antihemophilic factor IX from human plasma

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