Method of removing endotoxin from vaccines

Chemistry: molecular biology and microbiology – Virus or bacteriophage – except for viral vector or... – Recovery or purification

Reexamination Certificate

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C424S204100, C424S209100, C424S210100

Reexamination Certificate

active

09803778

ABSTRACT:
A method of removing bacterial endotoxin from a pharmaceutical process solution is disclosed. In one embodiment, the method comprises treating the solution with a surfactant effective to dissociate the endotoxin from a pharmaceutical drug or vaccine substance in the solution, and then filtering the solution through a molecular cut-off filter having a pore size effective to retain the pharmaceutical drug or vaccine substance but allow the dissociated bacterial endotoxin to pass therethrough.

REFERENCES:
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patent: 0 083 999 (1983-07-01), None
patent: WO 95/21179 (1995-08-01), None
Petsch, D. et al., “Membrane Adsorbers for Selective Removal of Bacterial Endotoxin,”J. Chrom. B., 693:79-91 (1997).
Schindler, R. and Dinarello, C.A., “A method for removing interleukin-1 and tumor necrosis factor-inducing substances from bacterial cultures by ultrafiltration with polysulfone,”J. Immun. Methods, 116:159-65 (1989).
Dawson, M. et al., “Microbes, Endotoxins and Water,”Pharm. Engineering, 8:20-23 (1988).
Sweadner, K.J. et al., “Filtration Removal of Endotoxin (Pyrogens) in Solution in Different States of Aggregation,”Applied and Environmental Microbiology, 34:382-85 (1977).
Nagy, L.K., “The Effect of Deoxycholate on Cholera Vaccine,”Progr. Immun. Standard, 5:341-47 (1972).
McIntire, F. et al., “Studies on a Lipopolysaccharide fromEscherichia coli, Heterogeneity and Mechanism of Reversible Inactivation of Sodium Deoxycholate,”Biochemistry, 8:4063-66 (1969).

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