Depyrogenation of clinical albumin
AssigneePlasmatech Corporation
InventorYu-Lee Hao
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Abstract
A simple method for the depyrogenation of clinical albumin is disclosed. It includes mixing the pyrogenic clinical albumin with human plasma, followed by a two-step albumin method reported previously by this inventor. The depyrogenated albumin, in the form of ethanol precipitate, can then be processed into clinical albumin according to the conventional procedures. This simple process not only results in the depyrogenation of the endotoxin--contaminated albumin, but also recovers the albumin which is present in the added plasma. The overall albumin yield is greater than 90% as calculated from the starting pyrogenic albumin and the albumin present in the added plasma.
Claims12
A method for the depyrogenation of clinical albumin comprising:
- (a) mixing at least the titrated amount of plasma with a given amount of pyrogenic albumin rendering the mixture non-pyrogenic as assayed by LAL test:
- (b) addition of physiological saline, 0.15 NaCl, to the mixture so that the protein concentration of 1.0 to 2.0% is reached;
- (c) adjusting the pH of the mixture to 5.75.+-.0.05;
- (d) precipitation of endotoxins and impurities in the reaction mixture by the addition of ethanol in an amount sufficient to give a final concentration of 42% at pH of 5.85.+-.0.05 at temperature of -5.degree. to -6.degree. C.;
- (e) removal of endotoxins and impurities as precipitate by centrifugation followed by filtration, or by direct filtration;
- (f) precipitating albumin from the said filtrate at pH 4.8 and recovery of albumin paste by centrifugation or filtration.
Dependencies are inferred from the claim text.