Overview
From the earliest stages of our project, we recognized that engineering a therapeutic for inflammatory bowel disease required not only technical excellence but also careful consideration of its ethical, social, safety, and sustainability implications. To ensure our work was responsible and grounded in real-world needs, we engaged early and often with academic experts, industry mentors, and fellow iGEM teams.
These interactions shaped every stage of our project—from computational protein design and laboratory methods to future plans for regulatory compliance, commercialization, and equitable access—reflecting the iGEM Human Practices principle that good science must also be good for the world.
Responsibility
Professor Maggie Horst: Professor at University of California San Francisco
Her research entails using “de novo protein design to explore foundational principles in biocatalysis, mechanotransduction, and macromolecular chemistry,” which made her the perfect candidate to assist us in protein design. Given her expertise, she helped us ensure that interleukin proteins’ design was created in a manner that was both safe and ethical for the biological community. As such, our team held weekly meetings with her for a duration of two months (from March to May) where we learned how to use the ThermoMPNN mutation model, ESM-Predictive models, Chai-1 protein analysis, and molecular analysis of point mutations including sterric clashes, disulfide bonds, hydrophobic, hydrophilic regions of protein, R-group interactions, structure of protein on pyMOL.
Adam McConnell: Postdoctoral Scholar at UCSF DeGrado Lab
In monthly meetings from February to April, Dr. McConnell helped us bridge computational design with practical production in E. coli. Under his guidance, we strengthened our skills in PyMOL for structural analysis, learned to use the IDT reverse-codon optimization tool, and established measurable benchmarks for improved IL-10, including temperature stability, receptor binding, and production yield. Because DeGrado Lab emphasizes rigorous design and translation, McConnell’s mentorship helped us keep our engineered proteins viable for real biological systems, not just theoretical models.
Kylie Woodman: Researcher at UC Santa Barbara
To ensure that our experimental results would withstand critical scrutiny, we consulted Kylie Woodman for statistical guidance. She helped us design experiments amenable to t-tests, variance analysis, and rigorous validation, ensuring that any claims of IL-10 stability improvements would be backed by statistically significant evidence rather than anecdotal trends. This emphasis on data integrity is a crucial pillar of responsibility—especially in biomedical research—helping guard against overclaiming or misrepresentation of results.
Professor Olga Korosteleva: California State University, Long Beach
We engaged Professor Korosteleva to help us plan ahead for the regulatory and translational trajectory of our therapeutic. She advised us on designing statistical validation frameworks and safety studies that we believed could later be compatible with later clinical regulatory pathways (e.g. FDA). Her input reminded us that responsibility doesn’t end at proof-of-concept as the design of experiments must anticipate safety, quality assurance, and compliance from the outset. This foresight strengthens our accountability to future patients and oversight bodies.
Collaboration
School #1: National Chung Cheng University
Through our exchange with National Chung Cheng University, we reflected on how scientific contexts differ globally. We compared disparities in funding mechanisms, equipment availability, reagent access, and human practices philosophy. These conversations surfaced inequities in research infrastructure, especially in less-resourced regions, and motivated us to make parts of our outreach and methods adaptable to lower-cost or lower-tech environments. Their professors contributed feedback on improving experimental design and human practices lessons, reinforcing that responsibility in synthetic biology demands sensitivity to global diversity in capability and context.
School #2: Kang Chiao International School
Interacting with the Kang Chiao high-school iGEM team provided a peer perspective on project planning and translation. By presenting our project, soliciting critique from other adolescents and PhD mentors, and observing how they integrated engineering and biological thinking, we gained fresh insight into how to make our science more accessible and robust. This exchange underscored that responsibility in outreach begins with inclusivity among peers: involving and learning from others at all levels strengthens a project’s ethical foundation and practical relevance.
Entrepreneurship
Overview
Entrepreneurship was a critical part of our Human Practices strategy, bridging the gap between innovative research and meaningful real-world impact. We recognized that a therapeutic cannot fulfill its promise if it remains confined to academic settings or is priced beyond the reach of patients. By exploring intellectual property strategies, such as provisional protection for our stability-enhanced IL-10 variants, optimized Shuffle T7 Express production pipeline, and probiotic-based delivery platform, we laid the groundwork for a pathway that preserves our innovation while keeping future access in focus.
We paired these steps with a comprehensive market analysis of the gut-health supplement and anti-inflammatory sectors, allowing us to understand the dynamics of consumer demand, cost barriers, and sustainability expectations. This analysis guided how we framed our therapeutic—not as another generic probiotic, but as a science-backed, clinically relevant solution that addresses both healthcare needs and gaps in the current market.
Intellectual Property
While IL-10 itself is a naturally occurring cytokine and therefore not patentable in its native form, our innovative engineering approach offers multiple avenues for intellectual property protection, a critical foundation for the commercial success of our therapeutic platform. IL-10’s natural instability, stemming from its homodimeric structure, limits its direct therapeutic application. Our project addresses this issue through a novel combination of point mutations designed to stabilize IL-10’s structure without disrupting its biological function.
Although the original IL-10 gene sequence is publicly available, the specific modified IL-10 constructs we have designed — including point mutations that enhance solubility, folding, and therapeutic durability — constitute patentable intellectual property. In addition, the use of the Shuffle T7 Express system for enhanced disulfide bond formation provides further innovation in our production pipeline.
Calimod is in the process of preparing a provisional patent application covering:
- The engineered IL-10 protein variants featuring stability-enhancing point mutations.
- The method of production utilizing the Shuffle T7 Express system for optimized solubility and yield.
- Potential delivery mechanisms employing engineered probiotic systems for localized anti-inflammatory therapy in the gut.
Filing a provisional patent provides protection for 12 months, during which we plan to complete further optimization studies, explore encapsulation and delivery strategies, and refine our final therapeutic formulations. Following this, we intend to file a full utility patent application to secure comprehensive protection of our engineered IL-10 proteins and associated delivery methodologies.
Market Analysis
The total global market for dietary supplements — including vitamins, minerals, probiotics, and specialty supplements — was valued at approximately $177.5 billion in 2021, with an expected CAGR of about 9.1% through 2030. The gut supplements industry was specifically the one we chose to focus on as our product’s concept revolves around creating a probiotic that is accessible. The gut health supplements industry is fast growing and currently in high demand, with science-backed products dominating the premium sector.
| Market Slice | Details |
|---|---|
| Market Size | Estimated $80 billion globally in 2025, expected to grow to $120+ billion by 2030. |
| U.S. Market | ~$25 billion in 2025 just for digestive health supplements. |
| Growth Rate | CAGR ~7–9%. |
| Key Segments |
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| Key Drivers |
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| Top Selling Formats |
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Recent Trends
| Trend | Description |
|---|---|
| Science-Backed Probiotics | Consumers increasingly prefer supplements with clinical trial evidence or specific strain identification (e.g., Lactobacillus rhamnosus GG) rather than generic “probiotic”. |
| Personalized Gut Health | Companies offering microbiome testing and personalized supplements (examples include firms like Viome; Seed Health launching personalized lines). |
| “Psychobiotics” (Gut-Brain Axis) | New focus on probiotics that affect mood, stress, and anxiety through gut-microbiome interaction. |
| Anti-Inflammatory Focus | Gut inflammation being marketed as linked to everything from skin conditions to fatigue. |
| Postbiotic Products | Some companies skip live bacteria and sell metabolites instead (e.g., butyrate supplements). |
| Sustainability and Clean Label | Consumers care about non-GMO, vegan, eco-friendly packaging, and “free from” claims (no gluten, soy, dairy). |
SWOT Analysis
Strengths
- Novel IL-10 stabilization and targeted delivery design.
- Clear RUO on-ramp enabling near-term revenue.
- Academic-to-industry collaboration potential.
Opportunities
- Partnerships with CROs, GI clinics, and wellness brands.
- PCT filing to support global licensing.
- Data flywheel from RUO kits to clinical-grade product.
Weaknesses
- Biologic manufacturing and cold-chain constraints.
- Regulatory timelines for live biotherapeutics.
Threats
- Crowded probiotics market and generic claims.
- IP overlap in cytokine analogs and delivery platforms.
Porter’s 5 Forces
- Competitive Rivalry: High in consumer probiotics; moderate in clinical RUO kits.
- Threat of Substitutes: Conventional anti-inflammatories and dietary protocols.
- Bargaining Power (Suppliers): Moderate due to specialized biologics inputs.
- Bargaining Power (Buyers): High for retail, moderate for labs and clinics.
- Threat of New Entrants: Moderate; know-how and IP create barriers.
Patent Process
- Disclosure and claim scoping with counsel.
- Provisional filing covering constructs, methods, and kits.
- Data expansion and claim broadening within 12 months.
- PCT filing and national-phase entry stratified by market.
- Continuation strategy aligned to product roadmap.
Milestones align with partner diligence: RUO kit launch, stability data, FTO opinion, and first clinical collaboration.
Conclusion
By integrating entrepreneurship into our Human Practices work, we moved beyond viewing it as a business exercise and instead treated it as a tool for equitable translation of research into accessible products. This approach aligns with iGEM’s Human Practices criteria by demonstrating that we considered the societal, economic, and ethical dimensions of deployment, anticipated future regulatory and market challenges, and designed our innovation with a focus on both scientific integrity and broad benefit to society.
Sustainability
Practical Sustainability in Design and Production
A core element of our responsibility was to design a therapeutic that is not only effective but also sustainable to produce, deliver, and scale. Traditional cytokine therapies often rely on costly recombinant protein production and require cold-chain storage, which limits their accessibility in low-resource settings and increases environmental burden. By focusing on probiotic-based delivery, we reduce reliance on repeated cold-chain distribution and allow for on-site, food-grade production formats such as yogurt or capsules, minimizing waste and energy consumption.
Global Vision and Long-Term Sustainability Goals
Beyond laboratory practices, we framed our project within the context of the UN Sustainable Development Goals (SDGs). By addressing inflammatory bowel disease through a probiotic therapeutic, we directly contribute to SDG 3: Good Health and Well-Being, expanding the potential for affordable treatment of chronic inflammatory conditions. Our partnerships with international teams and mentors foster SDG 17: Partnerships for the Goals, highlighting the role of collaboration in responsible innovation. By striving for cost-effective and scalable manufacturing, we align with SDG 9: Industry, Innovation, and Infrastructure, while our focus on reducing waste and resource-intensive delivery systems advances SDG 12: Responsible Consumption and Production. We believe that biotechnological progress must go hand-in-hand with equitable access and environmental stewardship, and these commitments guide both our current research and our vision for future translation of our therapeutic.
Societal Considerations
Throughout the project, we navigated ethical challenges such as respectfully engaging homeless individuals in gut-health discussions, balancing openness with the need to protect intellectual property, and communicating synthetic biology’s limits to avoid over-promising. Community outreach—such as bilingual gut-health surveys with seniors and interactive learning at the STEAM Fair—revealed barriers to understanding and access that we addressed in both communication style and design choices. By documenting these interactions and the feedback loops they created, we show how stakeholder perspectives actively shaped our project’s direction. Here are some key takeaways we gained from conducting multiple outreach events (which can be read more in inclusivity).
Engaging Vulnerable Communities
When we planned our Probiotics & Homelessness outreach, we wanted to highlight the often-overlooked issue of gut health among people experiencing homelessness. At the same time, we were careful to respect their dignity and privacy. Instead of collecting personal information, we simply offered free probiotics and had casual conversations about health. This experience reminded us that good Human Practices starts with listening to people’s needs before involving them in research.
Balancing Openness and IP Protection
We value open science and believe sharing knowledge helps everyone. But we also realized that without some protection, it would be harder to ensure that our stabilized IL-10 therapeutic could be developed and remain affordable. We chose to pursue provisional patents for our engineered proteins and production methods while keeping our outreach materials, protocols, and educational resources openly available. This approach let us share what we could while still paving a path for real-world impact.
Managing Expectations in Communication
Synthetic biology often gets described as a quick solution to big problems, but we knew that wasn’t the whole story. In our outreach with students, seniors, and the general public, we made a point of explaining that our therapeutic is still in the research stage and will require further testing and regulatory review before it could ever be used in healthcare. Being upfront about both the promise and the limits of our work helped us build trust and avoid over-promising.
Ensuring Equitable Access
We also asked ourselves who would actually benefit from our therapeutic. We realized that if it were too expensive or hard to distribute, it wouldn’t reach the people who need it most. That’s why we focused on a probiotic-based delivery model—it can be made more cost-effectively and shipped without the need for expensive cold-chain logistics. This design choice reflects our belief that innovation should be accessible, not just cutting-edge.
Our Takeaway
These challenges showed us that ethics isn’t just a checklist; it’s a mindset that guides decisions at every stage. By prioritizing respect, honesty, and fairness, we aimed to create a project that’s not only scientifically strong but also responsible, inclusive, and worthy of public trust.