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 cryoprotectant comprising polyethylene glycol in saline at a concentration of 30-90 g/L to form a diluted sample;
mixing the diluted sample with a mixing apparatus;
filtering the diluted sample to form a filtrate;
transferring the filtrate to a sample bag; and
sealing the sample bag;
freezing the sample bag including the filtrate; and
packaging the filtrate for shipping.
2. The method of claim 1 , wherein freezing the sample bag including the filtrate comprises storing the sample bag including the filtrate at a temperature of about −20° C. to about −80° C.
3. The method of claim 1 , wherein freezing the sample bag including the filtrate comprises storing the sample bag including the filtrate at a temperature of about −80° C.
4. The method of claim 1 , further comprising pre-cooling the sample bag including the filtrate at a temperature of about 4° C. to about −4° C. prior to freezing the sample bag including the filtrate.
5. The method of claim 1 , wherein packaging the filtrate for shipping comprising packing the frozen sample bag including the filtrate in an insulated box with one or more ice packs.
6. The method of claim 5 , further comprising packing a tube assembly in the insulated box, the tube assembly configured to transfer the filtrate from the sample bag to a patient.
7. The method of claim 1 , further comprising shipping the packaged frozen sample bag including the filtrate to an institution.
8. The method of claim 7 , further comprising storing the sample bag including the filtrate in a frozen state.
9. The method of claim 8 , further comprising thawing the sample bag including the filtrate prior to delivering the filtrate to a patient.
10. The method of claim 6 , wherein the sample bag comprises an enema bag and the tube assembly is configured to couple to enema bag.
11. A microbiota restoration therapy composition, comprising:
a processed fresh stool sample from a human donor;
wherein a serial dilution of 10 −5 of the processed fresh stool sample has a colony forming unit (CFU) count of about 30 to about 300 CFU when cultured on a Bacteroides Bile Esculin Agar (BBE) culture plate; and
wherein the processed fresh stool sample includes a cryoprotectant, the cryoprotectant comprising polyethylene glycol in saline at a concentration of 30-90 g/L;
wherein the microbiota restoration therapy composition is stored in a frozen state.
12. The microbiota restoration therapy composition of claim 11 , wherein the microbiota restoration therapy composition is configured to be shipped in the frozen state.
13. The microbiota restoration therapy composition of claim 11 , wherein the microbiota restoration therapy composition is disposed within a sample bag.
14. The microbiota restoration therapy composition of claim 11 , wherein the microbiota restoration therapy composition is stored at a temperature of about −20° C. to about −80° C.
15. The microbiota restoration therapy composition of claim 11 , wherein the microbiota restoration therapy composition is thawed from the frozen state prior to administering the microbiota restoration therapy composition to a patient.
16. A kit for delivering a microbiota therapy composition, the kit comprising:
a microbiota restoration therapy composition comprising a processed fresh stool sample from a human donor and a cryoprotectant, the cryoprotectant comprising polyethylene glycol in saline at a concentration of 30-90 g/L, the microbiota restoration therapy disposed in a frozen state in a sample bag;
wherein a serial dilution of 10 −5 of the processed fresh stool sample has a colony forming unit (CFU) count of about 30 to about 300 CFU when cultured on a Bacteroides Bile Esculin Agar (BBE) culture plate; and
a tube assembly for delivering the microbiota restoration therapy composition to a patient.
17. The kit of claim 16 , wherein the microbiota restoration therapy composition and the tube assembly are positioned within an insulated box.
18. The kit of claim 17 , wherein further comprising one or more ice packs positioned within the insulated box.
19. The kit of claim 18 , wherein the insulated box is configured to maintain the microbiota restoration therapy composition at a temperature of 20° C. or less for at least 36 hours.
20. The kit of claim 17 , wherein the insulated box is packaged within a second box.