Patent ID: 6551623
Filing Date: 2003-04-22
Classification: A61K,C07K

Abstract:
A substantially pure and consistently potent composition for use as an immunomodulator prepared by a process comprising:(a) mixing bovine bile with an equal amount of a solvent to produce a bile/solvent solution; (b) separating out the solvent to obtain a solution substantially free of solvent; (c) removing bile pigments from the solution to obtain a colorless liquid; (d) extracting the colorless liquid to obtain an aqueous phase; (e) dialyzing the aqueous phase in a dilute buffer solution having a pH of about 7.0 to about 8.56; (f) subjecting said dialyzed aqueous phase to a reversed phase HPLC column to obtain a substantially pure and consistently potent composition which has a consistently reproducible pattern on reverse-phase HPLC where peaks are seen early in the exclusion fraction at about 27 and 32 minutes; said composition consisting of: small molecular weight components of less than 3000 daltons in a buffered salt solution having a pH of about 7.0 to about 8.56, not more than 10 ppm ethanol and not more than 5 ppm ether, and no measurable levels of IL-1a, IL-1b, TNF, IL-6, IL-8, IL-4, GM-CSF, or IFN-gamma, wherein said composition is capable of stimulating monocytes and/or macrophages in vitro, is capable of modulating tumor necrosis factor production, shows no cytotoxicity to human peripheral blood mononuclear cells, and is not an endotoxin.