Microbiota restoration therapy (MRT), compositions and methods of manufacture

1. A method for manufacturing a microbiota restoration therapy composition, the method comprising:

collecting a plurality of fresh human fecal samples;

pooling the plurality of fresh human fecal samples;

adding a diluent to the pooled fresh human fecal samples to form a diluted sample;

wherein the diluent includes 30-90 g/L polyethylene glycol in saline;

mixing the diluted sample with a mixing apparatus;

filtering the diluted sample;

wherein filtering forms a filtrate;

transferring the filtrate to a sample bag; and

sealing the sample bag.

2. The method of claim 1 , wherein the plurality of fresh human fecal samples are from the same donor.

3. The method of claim 1 , wherein the plurality of fresh human fecal samples are from two or more different donors.

4. The method of claim 1 , wherein filtering the diluted sample includes filtering the diluted sample with a filter bag.

5. The method of claim 4 , wherein mixing the diluted sample with a mixing apparatus includes disposing the filter bag within the mixing apparatus.

6. The method of claim 1 , further comprising storing the sample bag at a temperature of about −20° C. to about −80° C.

7. The method of claim 1 , further comprising storing the sample bag at a temperature of about −80° C.

8. The method of claim 1 , further comprising pre-cooling the sample bag at a temperature of about 4° C. to about −4° C.

9. The method of claim 8 , further comprising freezing the pre-cooled sample and storing the frozen sample at a temperature of about −20° C. to about −80° C.

10. The method of claim 9 , further comprising thawing the frozen sample.

11. The method of claim 10 , wherein thawing the frozen sample includes thawing the frozen sample at a temperature of about 4° C. to about −4° C.

12. The method of claim 11 , further comprising packaging the thawed sample in an insulated packaging assembly.

13. The method of claim 12 , wherein the sample bag contains the microbiota restoration therapy composition, and further comprising administering the microbiota restoration therapy composition to a patient.

14. A method for medical treatment, the method comprising:

collecting a plurality of fecal samples from at least one pre-screened donor;

pooling the plurality of fresh human fecal samples;

transferring the pooled fecal samples to a filter bag;

adding a diluent to the filter bag;

wherein the diluent includes 30-90 g/L polyethylene glycol in saline;

sealing the filter bag;

transferring the sealed filter bag to a mixer;

transferring the filtrate from the filter bag to a sample bag;

wherein transferring the filtrate from the filter bag to a sample bag defines a microbiota restoration therapy composition within the sample bag;

sealing the sample bag;

cooling sample bag;

transferring the cooled sample bag to a controlled temperature storage device;

wherein transferring the cooled sample bag to a controlled temperature storage device includes freezing the microbiota restoration therapy composition;

thawing the frozen microbiota restoration therapy composition;

packaging the sample bag in an insulated packaging system;

shipping the packaged sample bag to a treatment facility; and

administering the microbiota restoration therapy composition to a patient.

15. The method of claim 14 , wherein the plurality of fresh human fecal samples are from the same pre-screened donor.

16. The method of claim 14 , wherein the plurality of fresh human fecal samples are from two or more different pre-screened donors.

17. The method of claim 14 , wherein administering the microbiota restoration therapy composition to a patient includes administering the microbiota restoration therapy composition to the patient with an enema tube.