Modified Glycine Precipitation Technique for the Preparation of Factor VIII Concentrate of High Purity and High Stability

Vox Sanguinis ◽  
1987 ◽  
Vol 52 (1-2) ◽  
pp. 10-14
Author(s):  
Teresa Brodniewicz-Proba ◽  
Denyse Beauregard
Keyword(s):  
Factor Viii ◽  
High Purity ◽  
High Stability ◽  
Precipitation Technique

Factor VIII Concentrate: What is “High Purity”?

1994 ◽  
Vol 72 (03) ◽  
pp. 483-484 ◽  
Author(s):  
Axel Schoppmann ◽  
Alfred Weber ◽  
Felix Hondl ◽  
Yendra Linnau
Keyword(s):  
Factor Viii ◽  
High Purity

Standardization of Factor VIII – IV. Establishment of the 3rd International Standard for Factor VIII: C Concentrate

1983 ◽  
Vol 50 (03) ◽  
pp. 697-702 ◽  
Author(s):  
T W Barrowcliffe ◽  
A D Curtis ◽  
D P Thomas
Keyword(s):  
Factor Viii ◽  
High Purity ◽  
Collaborative Study ◽  
World Health ◽  
Current Standard ◽  
Two Stage ◽  
International Standard ◽  
One Stage ◽  
The One ◽  
Health Organization

SummaryAn international collaborative study was carried out to establish a replacement for the current (2nd) international standard for Factor VIII: C, concentrate. Twenty-six laboratories took part, of which 17 performed one-stage assays, three performed two-stage assays and six used both methods. The proposed new standard, an intermediate purity concentrate, was assayed against the current standard, against a high-purity concentrate and against an International Reference Plasma, coded 80/511, previously calibrated against fresh normal plasma.Assays of the proposed new standard against the current standard gave a mean potency of 3.89 iu/ampoule, with good agreement between laboratories and between one-stage and two- stage assays. There was also no difference between assay methods in the comparison of high-purity and intermediate purity concentrates. In the comparison of the proposed standard with the plasma reference preparation, the overall mean potency was 4.03 iu/ampoule, but there were substantial differences between laboratories, and the two-stage method gave significantly higher results than the one stage method. Of the technical variables in the one-stage method, only the activation time with one reagent appeared to have any influence on the results of this comparison of concentrate against plasma.Accelerated degradation studies showed that the proposed standard is very stable. With the agreement of the participants, the material, in ampoules coded 80/556, has been established by the World Health Organization as the 3rd International Standard for Factor VIII :C, Concentrate, with an assigned potency of 3.9 iu/ampoule.

Parvovirus B19 transmission by a high-purity factor VIII concentrate

Transfusion ◽  
2005 ◽  
Vol 45 (6) ◽  
pp. 1003-1010 ◽  
Author(s):  
Chuan-ging Wu ◽  
Bobby Mason ◽  
Julia Jong ◽  
Dean Erdman ◽  
Laurel McKernan ◽  
...  
Keyword(s):  
Factor Viii ◽  
High Purity ◽  
Parvovirus B19

scholarly journals Conditions Contributing to the Stability of Factor VIII Coagulant Activity

1977 ◽  
Author(s):  
T. Exner ◽  
K.A. Rickard ◽  
H. Kronenberg
Keyword(s):  
Factor Viii ◽  
High Purity ◽  
Gel Filtration ◽  
Anion Exchange Chromatography ◽  
Exchange Chromatography ◽  
Buffer System ◽  
Factor Viii Activity ◽  
Coagulant Activity ◽  
The Stability ◽  
Degree Of Purification

Factor VTII tends to become less stable the greater its degree of purification. The loss of factor VIII during preparation of high activity concentrates makes such processes uneconomical. Conditions contributing to the stability of factor VIII were investigated.High purity factor VIII was incubated with plasma components fractionated by gel filtration and by anion exchange chromatography. Factor VIII activity was assessed initially and after several hours incubation. Several fractions destroying factor VIII activity were clearly resolved. Fractions stabilizing factor VIII were associated only with albumin.Various buffer systems were investigated similarly. A non-chelating buffer system containing albumin was found to give optimal factor VIII stability.

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