Microbiota restoration therapy (MRT), compositions and methods of manufacture
Microbiota restoration therapy compositions and methods for manufacturing, processing, and/or delivering microbiota restoration therapy compositions are disclosed. An example method for manufacturing a microbiota restoration therapy composition may include collecting a human fecal sample and adding a diluent to the human fecal sample to form a diluted sample. The diluent may include a cryoprotectant. The method may also include mixing the diluted sample with a mixing apparatus and filtering the diluted sample. Filtering may form a filtrate. The method may also include transferring the filtrate to a sample bag and sealing the sample bag.
1. A method for manufacturing a microbiota restoration therapy composition, the method comprising:
collecting a fresh human fecal sample;
adding a diluent to the fresh human fecal sample 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 filtering the diluted sample includes filtering the diluted sample with a filter bag.
3. The method of claim 2 , wherein mixing the diluted sample with a mixing apparatus includes disposing the filter bag within the mixing apparatus.
4. The method of claim 1 , further comprising storing the sample bag at a temperature of about −20° C. to about −80° C.
5. The method of claim 1 , further comprising storing the sample bag at a temperature of about −80° C.
6. The method of claim 1 , further comprising pre-cooling the sample bag at a temperature of about 4° C. to about −4° C.
7. The method of claim 6 , further comprising freezing the pre-cooled sample and storing the frozen sample at a temperature of about −20° C. to about −80° C.
8. The method of claim 7 , further comprising thawing the frozen sample.
9. The method of claim 8 , wherein thawing the frozen sample includes thawing the frozen sample at a temperature of about 4° C. to about −4° C.
10. The method of claim 9 , further comprising packaging the thawed sample in an insulated packaging assembly.
11. The method of claim 10 , wherein the sample bag contains the microbiota restoration therapy composition, and further comprising administering the microbiota restoration therapy composition to a patient.
12. A method for manufacturing, processing, and packaging a microbiota restoration therapy composition, the method comprising:
collecting a fecal sample from a pre-screened donor;
transferring the fecal sample 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 the 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; and
shipping the packaged sample bag to a treatment facility.
13. A method for medical treatment, the method comprising:
collecting a fecal sample from a pre-screened donor;
transferring the fecal sample 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.
14. The method of claim 13 , wherein transferring the cooled sample bag to a controlled temperature storage device includes transferring the cooled sample to a −80° C. freezer.
15. The method of claim 13 , wherein administering the microbiota restoration therapy composition to a patient includes administering the microbiota restoration therapy composition to the patient with an enema tube.