Microbiome-Derived Protein Therapeutics for Epithelial Barrier Restoration
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Solution Overview
Problem
Current therapies for inflammatory bowel disease (IBD) primarily focus on suppressing inflammation, neglecting the importance of epithelial barrier integrity, and there is a need for a therapeutic that can restore intestinal barrier function while stabilizing protein therapeutics during manufacturing and storage.
Innovation Solution
Development of novel protein therapeutics derived from the microbiome, specifically the Roseburia hominis strain, which enhance epithelial barrier integrity and reduce inflammation, along with methods for stabilizing these proteins for long-term use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If current anti-inflammatory therapies are used, then inflammation is suppressed, but epithelial barrier integrity is not restored
Solution Approach 1:
The therapy is divided into two distinct functional components: an anti-inflammatory agent to suppress inflammation and an epithelial barrier repair agent to restore barrier integrity. This segmentation allows each component to address its specific target without compromise, resolving the contradiction between inflammation suppression and barrier restoration.
Solution Approach 2:
The patent combines two therapeutic agents into a single pharmaceutical composition: an anti-inflammatory agent and an epithelial barrier repair agent. This merging allows simultaneous delivery of both therapeutic functions, ensuring that inflammation is suppressed while epithelial barrier integrity is restored, eliminating the trade-off between these two outcomes.
2Ease of manufacture
If protein therapeutics are produced without stabilization, then manufacturing is simpler, but protein stability during manufacturing and storage deteriorates
Solution Approach 1:
The patent modifies physical and chemical parameters of the protein therapeutic through stabilization methods including lyophilization (freeze-drying), adjustment of pH, addition of stabilizing excipients, and control of storage temperature. These parameter changes enhance protein stability during manufacturing and storage without significantly complicating the manufacturing process.
Solution Approach 2:
Stabilizing excipients and adjuvants are introduced as intermediary substances that protect the protein therapeutic from degradation. These intermediaries include buffers, sugars, amino acids, and other stabilizing agents that form a protective environment around the protein, preventing denaturation and aggregation during manufacturing and storage while maintaining ease of production.
Data Source
AI summary
The disclosure relates to therapeutic proteins and pharmaceutical compositions comprising said proteins, which have utility in treating various human diseases. In particular aspects, the disclosed therapeutic proteins are useful for treating human gastrointestinal inflammatory diseases and gastrointestinal conditions associated with decreased epithelial cell barrier function or integrity. Further, the disclosed therapeutic proteins are useful for treating human inflammatory bowel disease, including inter alia, Crohn's disease and ulcerative colitis.