Clinical evaluation of the hepatitis safety of a β-propiolactone/ultraviolet treated factor IX concentrate (PPSB)

Heinrich, D.; Kotitschke, R.; Berthold, H.

doi:10.1016/0049-3848(82)90035-4

Cited by 35 publications

(9 citation statements)

References 9 publications

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“…For example, by showing virus inactivation with lipid solvents, it was found that HCV is an enveloped virus (Bradley et al, 1983;Feinstone et al, 1983). The model was also used for evaluating a number of procedures for inactivating the virus in biological products, including formalin (Tabor & Gerety, 1980;Yoshizawa et al, 1982), chloroform (Bradley et al, 1983;Feinstone et al, 1983), heat (Tabor & Gerety, 1980;Yoshizawa et al, 1982;Purcell et al, 1985), β-propiolactone, and ultraviolet irradiation (Heinrich et al, 1982). The model was also used for evaluating a number of procedures for inactivating the virus in biological products, including formalin (Tabor & Gerety, 1980;Yoshizawa et al, 1982), chloroform (Bradley et al, 1983;Feinstone et al, 1983), heat (Tabor & Gerety, 1980;Yoshizawa et al, 1982;Purcell et al, 1985), β-propiolactone, and ultraviolet irradiation (Heinrich et al, 1982).…”

Section: Essential Role Of Chimpanzee Model In Understanding Hcvmentioning

confidence: 99%

Cell-Based and Animal Models for Hepatitis B and C Viruses

Schinazi

Ilan

Black³

et al. 1999

Antivir Chem Chemother

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Reliable cell-based assays and animal models have been developed for evaluating agents against hepatitis B virus. Although much progress has been made, in vitro and in vivo assays for hepatitis C virus are still on the horizon. Advances towards establishing inexpensive and reliable experimental models have accelerated the development of therapeutic modalities for these life-threatening viral infections. The characterization of well-defined viral targets coupled with improved molecular diagnostic technologies have illuminated this field.

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Section: Essential Role Of Chimpanzee Model In Understanding Hcvmentioning

confidence: 99%

Cell-Based and Animal Models for Hepatitis B and C Viruses

Schinazi

Ilan

Black³

et al. 1999

Antivir Chem Chemother

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“…The safety of other blood-derivative proteins, such as coagulation factors, could be improved, first by the incorporation of a heating procedure in the lyophilized state to kill HIV viruses [2], and second, by the introduction of a solvent detergent method to inactivate all enveloped viruses [3]. Other methods can be used including heating of coagulation factors in the liquid phase [4] or b-propiolactone treatment [5]. Today almost all plasma derivatives are virus-inactivated.…”

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confidence: 99%

Virus Inactivation of Fresh Frozen Plasma by a Solvent Detergent Procedure: Biological Results

et al. 1992

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In order to increase the safety of blood products, we have developed a procedure for the virus inactivation of fresh frozen plasma. Several batches have been prepared and with the first 10 batches, each of them composed of 60 litres of plasma, we have determined a set of biological parameters. Virus inactivation was realised using TnBP (1%) and Octoxynol 9 (1%). After their elimination with castor oil using chromatography on insolubilized C18 resin, glycine was added and the pH of the plasma was adjusted to 7.4. Plastic bags were aseptically filled with a mean volume of 200 ml of plasma. The mean levels of coagulation factors were all over 0.7 U/ml and their recovery from initial plasma was nearly the same as total protein except for factor VIII:C. The net loss in factor VIII:C was 16%, when including the dilution of plasma. In vivo and in vitro tests demonstrated that in the final product there were no activated factors. As in fresh frozen plasma, the protein concentration was over 50 g/l and the potassium level lower than 5 mmol/l. According to these results, virus-inactivated plasma has the same qualities of fresh frozen plasma and could now replace it.

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“…The first attempt to treat large‐pool plasma‐derived concentrates with methods meant to decrease the risk of transmission of hepatitis viruses was made by the industrial manufacturer Biotest, which, in 1982, reported no hepatitis in a small group of normal volunteers infused with a prothrombin complex concentrate in which virus inactivation was achieved by adding the chemical β‐propiolactone and applying ultraviolet light . This report raised a number of ethical questions, not only because volunteers were recruited from among the staff of Biotest, but also because β‐propiolactone was a potentially carcinogenic compound.…”

Section: Heat Treatment As a Virucidal Methodsmentioning

confidence: 99%

Viral safety of coagulation factor concentrates: memoirs from an insider

Mannucci

2018

Journal of Thrombosis and Haemostasis

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The purpose of this essay is to recall the actions taken globally to improve the viral safety of coagulation factor concentrates, mainly in the years 1985-1990, at a time of confusing and often contradictory information on bloodborne viral infections in multitransfused patients with hemophilia (PWHs). I shall first recall the problem of the transmission and control of the hepatitis viruses, and then that of HIV: not only for temporal reasons, but also because understanding the progress of knowledge on hepatitis and the poor success of the early measures taken to tackle this problem in PWHs is essential to understand how the problem of HIV transmission was ultimately dealt with successfully.

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Clinical evaluation of the hepatitis safety of a β-propiolactone/ultraviolet treated factor IX concentrate (PPSB)

Cited by 35 publications

References 9 publications

Cell-Based and Animal Models for Hepatitis B and C Viruses

Cell-Based and Animal Models for Hepatitis B and C Viruses

Virus Inactivation of Fresh Frozen Plasma by a Solvent Detergent Procedure: Biological Results

Viral safety of coagulation factor concentrates: memoirs from an insider

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