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

摘要

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.

主权项

1. A method for producing a microbiota restoration therapy composition from a human stool sample, the method comprising:
collecting a fresh stool sample from a human donor; adding an amount of saline to the fresh stool sample; adding polyethylene glycol to the fresh stool sample at a concentration of 30-90 g/L; mixing the fresh stool sample, saline, and polyethylene glycol together to make a mixed composition; filtering the mixed composition and collecting the filtrate; removing a portion of the filtrate for testing; pre-cooling the remainder of the filtrate and then freezing the remainder of the filtrate; storing the frozen filtrate under quarantine; holding the frozen filtrate under quarantine until (a) testing the portion of the filtrate to measure the viability and quality of microbiota within the filtrate, (b) confirming the viability and quality of the filtrate, (c) confirming the health of the human donor by a pre-screening test, and (d) further confirming the health of the human donor by a plurality of post-screening tests occurring within a time period of 15-120 days post-donation; and releasing the filtrate from quarantine to define a microbiota restoration therapy composition.