Control of Large-Scale Plasma Thawing

Foster, Peter R.; Dickson, Alan J.

doi:10.1007/978-1-4613-2631-1_8

Cited by 6 publications

(2 citation statements)

References 7 publications

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“…commun.]. Sim ilar trends have occurred in Scotland where the produc tion of intermediate purity FVIII increased from just under 4 MU in 1980 to 13 MU in 1984 [Foster and Dickson, 1985], This increase has been met in Scotland over the last 5 years from plasma recovered and frozen within 18 h from normal donations (recovered fresh froz en plasma, RFFP). This plasma is further classified as RFFP 8 and RFFP 18 according to whether it was frozen within 8, or between 8 and 18 h of donation.…”

Section: Introductionmentioning

confidence: 94%

Importance of a Quality Assurance Scheme for Factor VIII Assays in Quality Monitoring of Human Plasma Destined for Fractionation into Factor VIII Concentrate

Gabra¹,

Prowse²,

Boulten³

1989

Vox Sanguinis

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A national quality assurance scheme has been established to monitor the validity of factor VIII assays performed by the various laboratories of the Scottish National Blood Transfusion Service engaged in collection and processing of donor plasma destined for fractionation. The results over the first 3-year period show that comparable assay values can be obtained by participating centres using a common standard, despite differences in equipment, methods or substrate chosen for the one-stage assay. The results also showed that chromogenic factor VIII assays correlated well with the one-stage method. Random factor VIII assays performed on plasma, harvested and frozen within 18 h from collection, were analysed to validate recently proposed Scottish specifications which stipulate that 70% of plasma donations destined for fractionation should contain at least 0.7 IU/ml. Plasma harvested and frozen between 8 and 18 h from collection did not meet the specified level in any of the regional centres. This nationally specified level was also not met by plasma harvested and frozen within 8 h from collection in spite of being achieved individually by three regional centres. Assays performed on large plasma pools at the Fractionation Centre suggested loss of some factor VIII during storage, transportation and thawing of plasma prior to bulk processing.

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Section: Introductionmentioning

confidence: 94%

Importance of a Quality Assurance Scheme for Factor VIII Assays in Quality Monitoring of Human Plasma Destined for Fractionation into Factor VIII Concentrate

Gabra¹,

Prowse²,

Boulten³

1989

Vox Sanguinis

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“…product formulation, 0.22pm membrane filtration and aseptic dispensing) prior to freeze-drying. Although re design of the cryoprecipitation procedure has given a substantial yield improvement [2, 5,6], we have contin ued this project by examining the VIIIiC loss over product finishing and it is the results of this study which are reported here.…”

Section: Introductionmentioning

confidence: 99%

Studies on the Stability of VIII:C during the Manufacture of a Factor VIII Concentrate for Clinical Use

Foster¹,

Dickson²,

McQuillan³

et al. 1988

Vox Sanguinis

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The stability of VIII:C was investigated by monitoring samples taken at different points from a routine process for the manufacture of factor VIII concentrate and by examining the stabilising influence of a number of product formulations. Loss of VIII:C over process-finishing procedures (formulation, 0.22 µm filtration, dispensing) was associated with a citrate-induced inactivation which could be prevented by controlling the ionised calcium concentration of the solution. These results were obtained using a one-stage clotting assay but were not observed using a two-stage assay. No evidence for activation was found in vitro (e.g. by FPA generation and VIII:C stability) and the yield increase suggested by the one-stage assay was supported by results from a controlled clinical evaluation.

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Separation and Purification of Cold Insoluble Globulines

Sibinga¹,

Das²

1990

Cryopreservation and Low Temperature Biology in Blood Transfusion

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Control of Large-Scale Plasma Thawing

Cited by 6 publications

References 7 publications

Importance of a Quality Assurance Scheme for Factor VIII Assays in Quality Monitoring of Human Plasma Destined for Fractionation into Factor VIII Concentrate

Importance of a Quality Assurance Scheme for Factor VIII Assays in Quality Monitoring of Human Plasma Destined for Fractionation into Factor VIII Concentrate

Studies on the Stability of VIII:C during the Manufacture of a Factor VIII Concentrate for Clinical Use

Separation and Purification of Cold Insoluble Globulines

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