ISOLATED INTESTINAL MUCOSA AND USES THEREOF

1 . A method of manufacturing metabolically competent isolated intestinal mucosal comprising villi eluted from intestines, comprising:

a) eluting the intestinal mucosal from lumen of the intestines to form isolated intestinal mucosa;

b) suspending the isolated intestinal mucosa in a cell culture medium;

c) adding a cryoprotectant to the cell culture medium to form an in vitro reagent; and,

d) storing the in vitro reagent frozen at a temperature of −10° C. to about −175° C.

2 . The method of claim 1 , wherein the reagent is stored frozen in liquid nitrogen.

3 . The method of claim 1 , further comprising use of an enzyme in step a).

4 . The method of claim 3 , wherein the enzyme is collagenase or a protease.

5 . The method of claim 1 , wherein the isolated intestinal mucosa comprising villi are mammal.

6 . The method of claim 5 , wherein the isolated intestinal mucosa comprising villi are human.

7 . The method of claim 1 , wherein the metabolically competent isolated intestinal mucosa comprises enterocytes.

8 . The method of claim 1 , wherein the metabolically competent isolated intestinal mucosa comprising villi are pooled from more than one donor.

9 . An in vitro reagent for evaluating biological activity of a test substance, wherein the reagent is a cryopreserved mixture comprising:

a) a cell culture medium comprising a cryoprotectant; and,

b) metabolically competent isolated intestinal mucosa comprising villi wherein the intestinal mucosa was eluted from an intestine.

10 . (canceled)

11 . The reagent of claim 9 , wherein the isolated intestinal mucosa comprising villi are human.

12 . The reagent of claim 9 , wherein the metabolically competent isolated intestinal mucosa comprises enterocytes.

13 . The reagent of claim 9 , wherein the in vitro reagent is stored frozen at a temperature of −10° C. to about −175° C.

14 . The reagent of claim 9 , wherein the in vitro reagent is thawed prior to use for evaluating biological activity of a test substance.

15 . The reagent of claim 9 , wherein the in vitro reagent is provided in a kit and further comprises instructions for evaluating biological activity of a test substance using the reagent.

16 . The reagent of claim 9 , wherein the metabolically competent isolated intestinal mucosa comprising villi are pooled from more than one donor.

17 - 33 . (canceled)

34 . A method for evaluating in vitro inhibition or induction of cytochrome P450 by a test compound that is ingested or administered orally, comprising:

a) providing metabolically competent isolated intestinal mucosa comprising villi wherein the intestinal mucosa was eluted from an intestine and previously cryopreserved;

b) culturing the isolated intestinal mucosa in a cell culture vessel incubated at 30-45° C.;

c) introducing a test compound into the cell culture vessel that is suspected of being a P450 ligand;

d) incubating the test compound for 1 minute to 10 days at 30-45° C.; and,

e) performing an end point assay of the isolated intestinal mucosa or cell culture medium to determine P450 activity.

35 . The method of claim 34 , wherein the test compound suspected of being a P450 ligand is a substrate of P450.

36 . (canceled)

37 . (canceled)

38 . The method of claim 34 , wherein the test compound is a drug or drug candidate selected from the group consisting of an organic compound, an inorganic compound, a hormone, a growth factor, a cytokine, a reception, an antibody, an enzyme, a peptide, a NSAID, an aptomer and a vaccine.

39 . The method of claim 38 , wherein the drug or drug candidate is added at cytotoxic concentrations for identifying and profiling metabolites.

40 . The method of claim 34 , wherein complete phase 1 oxidation and phase 2 conjugation of metabolites are evaluated with the reagent of step a).

41 - 50 . (canceled)