Unmasking endotoxins in solution

1. An aqueous composition comprising a protein, an aliphatic compound with C8-C16 as the main chain, and lipopolysaccaride (LPS), wherein the aliphatic compound is an alkanol, and wherein the protein is chosen from an antibody, an antibody fragment, a hormone, an enzyme, a fusion protein, and any combination thereof.

2. The aqueous composition according to claim 1 , wherein the alkanol is an unbranched 1-alkanol.

3. The aqueous composition according to claim 1 , wherein the alkanol is a branched compound with at least one substitution in the main chain selected from a methyl, ethyl, propyl and butyl group.

4. The aqueous composition according to claim 1 , further comprising a detergent selected from an anionic detergent, a cationic detergent, a nonionic detergent, an amphoteric detergent and any combination thereof.

5. The aqueous composition according to claim 4 , wherein said detergent is an anionic detergent chosen from the group consisting of: alkyl sulfates; alkyl-ether sulfates; cholesterol sulfate; sulfonates; alkyl sulfo succinates; sulfoxides; phosphates; and carboxylates.

6. The aqueous composition according to claim 4 , wherein said detergent is a cationic detergent chosen from the group consisting of: primary amines; secondary amines; tertiary amines; and quaternary ammonium cations; cetylpyridinium chloride (CPC); quaternary ammonium detergents; and hydroxyethylcellulose ethoxylate, quaternized (Polyquaternium-10).

7. The aqueous composition according to claim 4 , wherein said detergent is a nonionic detergent chosen from the group consisting of: polyoxyethylene glycol sorbitan alkyl esters (polysorbates); polyoxyethylene glycol alkyl ethers; polyoxypropylene glycol alkyl ethers; glucoside alkyl ethers; polyoxyethylene glycol octylphenol ethers; polyoxyethylene glycol alkylphenol ethers; glycerol alkyl esters; sorbitan alkyl esters; block copolymers of polyethylene glycol and polypropylene glycol; cocamide MEA; sterols; cyclodextrins; poloxamers; and cocamide DEA.

8. The aqueous composition according to claim 4 , wherein said detergent is an amphoteric detergent chosen from the group consisting of: CHAPS (3-[(3-Cholamidopropyl)dimethylammonio]-1-propanesulfonate); sultaines; betaines; amino oxides; and lecithin.

9. The aqueous composition according to claim 4 , wherein the detergent is selected from Polysorbate 20, Polysorbate 80, Poloxamer 188, Octoxynol 9, Laurylamineoxid, tris[2-(2-hydroxyethoxy)ethyl]-octadecyl-ammonium phosphate, trilaureth-4 phosphate and sodium stearate.

10. The aqueous composition according to claim 1 , wherein the antibody fragment is selected from a Fab, a Fab′, a F(ab′)2 and an Fv, a single chain antibody and any combination thereof.

11. The aqueous composition according to claim 1 , containing a further protein which is an albumin.

12. The aqueous composition according to claim 1 , further comprising a chaotropic agent, a cation or a combination thereof.

13. The aqueous composition according to claim 12 , wherein the composition comprises a chaotropic agent selected from urea, guanidinium chloride, butanol, ethanol, lithium perchlorate, lithium acetate, magnesium chloride, phenol, propanol and thiourea.

14. The aqueous composition according to claim 12 , wherein the composition comprises a cation that is a divalent cation.

15. The aqueous composition according to claim 14 , wherein the divalent cation is selected from Ca2+, Mg2+, Sr2+ and Zn2+.

16. The aqueous composition according to claim 11 , wherein the further protein is present in a concentration from 0.1-20 mg/ml; the aliphatic compound is present in the concentration from 0.01-100 mM; the detergent is present in a concentration from 0.001-1.0 wt %; and/or the divalent cation is present in the concentration from 1-400 mM.

17. The aqueous composition according to claim 16 , further comprising a chaotropic agent in a concentration from 1 mM-1 M.

18. The aqueous composition according to claim 1 , wherein the pH is in the range from pH 2-12.

19. The aqueous composition according to claim 1 , further containing Factor C protein.

20. The aqueous composition according to claim 2 , wherein the unbranched 1-alkanol is 1-dodecanol.

21. The aqueous composition according to claim 5 , wherein said detergent is ammonium lauryl sulfate or sodium lauryl sulfate (SDS).

22. The aqueous composition according to claim 5 , wherein said detergent is sodium laureth sulfate or sodium myreth sulfate.

23. The aqueous composition according to claim 5 , wherein said detergent is dodecylbenzensulfonate, sodium lauryl sulfoacetate or xylene sulfonate.

24. The aqueous composition of claim 5 , wherein the detergent is disodium lauryl sulfosuccinate.

25. The aqueous composition according to claim 5 , wherein said detergent is dodecyl methyl sulfoxide or trilaureth-4 phosphate.

26. The aqueous composition according to claim 5 , wherein said detergent is sodium stearate or sodium lauroyl sarcosinate.

27. The aqueous composition according to claim 6 , wherein said detergent is an alkyltrimethylammonium salt.

28. The aqueous composition according to claim 27 , wherein said detergent is cetyl trimethylammonium bromide (CTAB) or cetyl trimethylammonium chloride (CTAC).

29. The aqueous composition according to claim 6 , wherein said detergent is tris[2-(2-hydroxyethoxy)ethyl]-octadecyl-ammonium phosphate.

30. The aqueous composition according to claim 7 , wherein said detergent is polysorbate 20, polysorbate 40, polysorbate 60 or polysorbate 80.

31. The aqueous composition according to claim 7 , wherein said detergent is cholesterol.

32. The aqueous composition according to claim 7 , wherein said detergent is a poloxamer block polymer.

33. The aqueous composition according to claim 8 , wherein said detergent is cocamidopropyl hydroxysultaine or cocamidopropyl betaine.

34. The aqueous composition according to claim 8 , wherein said detergent is palmitamine oxide, laurylamine oxide or amine oxide of general formula R 3 N + O − , wherein R 3 is C 8 -C 18 alkyl, C 8 -C 18 alkenyl, or C 8 -C 18 alkynyl.

35. The aqueous composition according to claim 11 , wherein the further protein is human serum albumin, bovine serum albumin and/or ovalbumin.

36. The aqueous composition according to claim 16 , wherein the further protein is present in a concentration from 1-10 mg/ml; the aliphatic compound is present in the concentration from 0.1-10 mM; the detergent is present in a concentration from 0.05-0.5 wt %; and/or the divalent cation is present in the concentration from 10-200 mM.

37. The aqueous composition according to claim 19 , wherein the Factor C protein is a recombinant Factor C protein.