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US 6,441,144 B1Granted
Method for repairing dual virally inactivated immune globulin for intravenous administration
AssigneeAlpha Therapeutic Corporation
InventorsRaja R. Mamidi, Andranik Bagdasarian, Gorgonio Canaveral, Kazuo Takechi
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Abstract
A process for producing an intravenously-administrable gamma globulin solution substantially free of contaminating viruses by fractionating an impure gamma globulin solution and then treating the purified gamma globulin, with a solvent-detergent for viral inactivation and a heat treating for viral inactivation. Thereafter, denatured impurities, residual solvent and aggregate generated by the heat treatment are removed from the gamma globulin.
Claims21
A process for preparing an intravenously administrable γ-globulin solution which comprises:
- (a) subjecting an impure γ-globulin solution to polyethylene glycol fractionation for obtaining a purified γ-globulin;
- (b) treating the polyethylene glycol purified solution of γ-globulin with an organic solvent for inactivating envelope viruses;
- (c) heat treating the polyethylene glycol purified solution of γ-globulin under time and temperature conditions sufficient for inactivating heat sensitive viruses;
- and then
- (d) removing aggregates generated by the heat treatment;
- wherein heat treatment step (c) is carried out on the γ-globulin-organic solvent solution resulting from step (b) without any intervening processing.
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Dependencies are inferred from the claim text.