Microbiota Restoration Therapy Composition Processing
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Solution Overview
Problem
Current treatments for Clostridium difficile infections, such as antibiotic therapy, have high recurrence rates and mortality, and fecal transplantation lacks standardization and quality control, making it an inefficient and unreliable primary treatment option.
Innovation Solution
Development of a standardized microbiota restoration therapy composition using a mixture of fecal microbiota and a cryoprotectant like polyethylene glycol, which is processed and stored to ensure viability and quality, allowing for standardized and effective administration to patients.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If fecal transplantation is used to treat Clostridium difficile infections, then treatment effectiveness may improve, but lack of standardization and quality control reduces reliability
Solution Approach 1:
The patent applies parameter changes by standardizing critical parameters of the fecal microbiota transplantation process, including donor selection criteria, sample collection protocols, processing parameters (filtration, concentration, formulation), storage conditions, and administration dosing. This standardization transforms an unstandardized procedure into a controlled medical therapy with defined quality parameters, resolving the contradiction between treatment effectiveness and manufacturing precision.
Solution Approach 2:
The patent introduces an intermediary processing system between fecal sample collection and patient administration. This intermediary includes standardized processing protocols, quality control testing, and formulation steps that ensure consistency and safety. The intermediary layer provides the missing standardization while preserving the therapeutic benefits of the microbiota transplantation.
2Reliability
If antibiotic therapy is used to treat Clostridium difficile infections, then initial treatment may succeed, but recurrence rates are high
Solution Approach 1:
The patent converts the harmful effect of antibiotic-induced microbiota depletion into a beneficial opportunity for introducing healthy, diverse microbiota. By first eliminating pathogenic bacteria with antibiotics and then replenishing the gut ecosystem with donor microbiota, the treatment transforms the harm of antibiotic therapy into a reset opportunity for the gastrointestinal microbiome, preventing recurrence while maintaining initial treatment success.
Solution Approach 2:
The patent applies preliminary action by preparing and introducing healthy microbiota immediately after antibiotic treatment while the gastrointestinal tract is still susceptible and ready for colonization. This timing ensures that the introduced microbiota establishes itself before pathogenic bacteria can rebound, providing prolonged protection against recurrence while maintaining the benefits of initial antibiotic therapy.
3Productivity
If fecal samples are collected and processed without standardization, then treatment can be administered quickly, but quality and viability of microbiota cannot be ensured
Solution Approach 1:
The patent segments the fecal microbiota transplantation process into distinct modular steps: donor screening, sample collection, processing (filtration, concentration, formulation), quality control testing, storage, and administration. Each segment has standardized protocols and quality checkpoints, allowing parallel processing and efficient workflow management that maintains both speed and quality control.
Solution Approach 2:
The patent establishes standardized parameter ranges for critical process variables including pH, temperature, concentration, and viability thresholds at each processing stage. These parameter specifications enable automated quality control and ensure consistent microbiota quality while allowing efficient batch processing that maintains treatment administration speed.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The microbiota restoration therapy composition effectively displaces pathogenic organisms with healthy gut flora, reducing recurrence rates of Clostridium difficile infections and improving patient outcomes by ensuring the quality and viability of the microbiota at the time of delivery.
Implementation Method 1
The diluent may include a cryoprotectant
Implementation Method 2
mixing the diluted sample with a mixing apparatus
Implementation Method 3
filtering the diluted sample. Filtering may form a filtrate
Implementation Method 4
transferred the cooled sample bag to a controlled temperature storage device. Transferring the cooled sample bag to a controlled temperature storage device may include freezing the microbiota restoration therapy composition
Data Source
AI summary
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.