Preparation of lyophilized heat-treated cryoprecipitates from a small pool of plasma obtained by apheresis

Allersma, D. P.; Roeffen, E.; Does, J. A. van der; Briët, E.

doi:10.1007/bf01963879

Cited by 5 publications

(3 citation statements)

References 15 publications

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“…To date, limited technical choice is available for the inactivation of cryoprecipitate. Dry‐heat treatment of small‐pool blood‐bank cryoprecipitate has been described [38,39]. A similar process, where freeze‐dried cryoprecipitate is heated at 60 °C for 25 h, is used in Thailand [20] to inactivate HIV, but HCV transmission has been reported [20].…”

Section: Discussionmentioning

confidence: 99%

A minipool process for solvent–detergent treatment of cryoprecipitate at blood centres using a disposable bag system

Burnouf¹,

Goubran

Radosevich³

et al. 2006

Vox Sanguinis

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Viral inactivation treatment by TnBP, with or without Triton X-45, can be applied to minipools of cryoprecipitate, with good recovery of FVIII, VWF and fibrinogen. The viral inactivation and solvent-detergent removal process can be performed in a closed bag system and using simple blood establishment techniques and equipment. This technology could be considered for the improved viral safety of cryoprecipitate which is used to treat haemophilia A, von Willebrand disease or fibrinogen deficiency, or to prepare fibrin sealant.

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Section: Discussionmentioning

confidence: 99%

A minipool process for solvent–detergent treatment of cryoprecipitate at blood centres using a disposable bag system

Burnouf¹,

Goubran

Radosevich³

et al. 2006

Vox Sanguinis

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“…A small pool process where cryoprecipitate is pooled, freeze‐dried and heated at 60 °C for 25 h has been developed in Thailand [28,29]. The procedure of heat treatment, in combination with viral testing of blood donations, was shown to provide safety against the risk of transmission of HIV, but occasional transmission of HCV by this preparation has been reported [29].…”

Section: Dry‐heat Viral Inactivation Of Cryoprecipitatementioning

confidence: 99%

Preparation and viral inactivation of cryoprecipitate in blood banks in resource‐limited countries

Burnouf¹,

Goubran

Radosevich³

et al. 2007

ISBT Science Series

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Non-virally inactivated cryoprecipitate prepared by blood banks is still used in many countries, especially in the developing world, for the treatment of bleeding disorders due to factor VIII (FVIII), von Willebrand factor (VWF), or fibrinogen deficiency. As a consequence, patients receiving cryoprecipitate are at high risk of being infected by plasma-borne viruses, such as HIV, and hepatitis B virus (HBV) or C virus (HCV). It is therefore urgent to develop easy-to-use, affordable and efficient methods for the viral inactivation of cryoprecipitate under conditions that ensure good maintenance of its haemostatic properties. Preparation of cryoprecipitate from large-pool solventdetergent (SD) plasma seems not economically or technically feasible in developing countries. Cryoprecipitate prepared from single-donor plasma virally inactivated by methylene-blue/illumination has significantly reduced content of factor VIII and fibrinogen. There are no data on the quality of cryoprecipitate produced from plasma virally inactivated by techniques in development such as S-51 psoralen/UV irradiation or by riboflavin/UV irradiation, but loss of FVIII and fibrinogen is reported in S-51/ UV-treated plasma. Dry-heat treatments of smallpool cryoprecipitate or intermediatepurity factor VIII have been developed for use by blood banks, but they are not much used and some have not stopped the risk of transmission of HCV. Recently, a mini-pool process and a closed bag system to perform SD treatment of cryoprecipitate have been developed for use by blood banks. Recovery of factor VIII, VWF, and fibrinogen is over 95%. Viral validation studies revealed reduction factors of > 4·17, > 4·73, and > 4·72 for HIV, BVDV, and PRV, respectively, within a few minutes of treatment. The SD bag system is in the process of CE-marking and field testing should start in the near future.

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“…In recent years, the blood banks produced a cryocentrate extracted in a stabilizing amino acid solution. This product was freeze dried and heated for 72 h at 60 °C [1,2], This virucidal heat treatment however is known to be inefficient in preventing the transmission of the non-A non-B hepatitis virus [3,4]. Therefore a new manufactur ing process was developed, in order to apply the severe nally described by Thorell and Blomback [10].…”

mentioning

confidence: 99%

Development and Small-Scale Production of a Severely Heated Factor VIII Concentrate

Knevelman¹,

Wit²,

Potstra³

et al. 1994

Vox Sanguinis

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The small-scale production of a severely heated factor VIII concentrate is described. As starting material for the production 48 units of fresh frozen plasma from whole-blood donations or 24 units of plasma from apheresis are used. During a glycine and sodium chloride fractionation, contaminating proteins are removed from a pooled extract of single-donor cryoprecipitates. The resulting factor VIII-rich precipitate is redissolved in freeze-drying buffer and this solution is desalted by diafiltration. After filtration, this solution is dispensed into 10 vials and frozen. The product is freeze dried, and heat treated at 80°C for 72 h. The mean yield of the heat-treated product improved from 160 IU factor VIII per liter plasma at the start of the production to 215 IU per liter plasma after a modification of the purification process. The validation of the virus inactivation during freeze-drying and 80°C heat treatment for 72 h showed a reduction of ≥ 7.6 log PFU/ml for Sindbis and a reduction of ≥ 6.4 log TCID(50)/ml for HIV-1. The factor VIII concentrate was clinically tested in 6 patients. It possessed a normal half-life, showed a high recovery and no side effects. A Dutch license was granted in June 1991 and since then this product has been routinely manufactured in three Dutch blood banks.

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Preparation of lyophilized heat-treated cryoprecipitates from a small pool of plasma obtained by apheresis

Cited by 5 publications

References 15 publications

A minipool process for solvent–detergent treatment of cryoprecipitate at blood centres using a disposable bag system

A minipool process for solvent–detergent treatment of cryoprecipitate at blood centres using a disposable bag system

Preparation and viral inactivation of cryoprecipitate in blood banks in resource‐limited countries

Development and Small-Scale Production of a Severely Heated Factor VIII Concentrate

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