Microplastics are everywhere. With the widespread use of plastic products, the global production of plastic waste is increasing day by day. According to the 2022 report "Global Plastics Outlook: Economic Drivers, Environmental Impacts and Policy Options" released by the Organization for Economic Cooperation and Development (OECD), global plastic waste increased from 156 million tons in 2000 to 353 million tons in 2019, nearly doubling. However, only 9% of plastic waste is recycled, nearly 50% is sent to sanitary landfills, and even 22% is discarded in uncontrolled landfills, incinerated in open pits, or leaked into the environment^[1]. Excessive plastics can enter the human body in the form of tiny particles, known as microplastics. Ingestion is one of the main ways for microplastics to enter the human body^[2]. After entering the gastrointestinal tract, microplastics can release harmful chemicals, cause functional disorders and systemic inflammation, disrupt the intestinal microbiome, and are difficult to avoid or eliminate by the human body itself, seriously endangering human health^[3].

Currently, most studies aim to reduce microplastic intrusion as much as possible through lifestyle adjustments and environmental governance^[4], but this method has poor stability, large individual differences, and difficult-to-evaluate therapeutic effects. Some researchers have tried to regulate the intestinal flora balance through probiotics to repair the damage caused by microplastics to the intestine. However, genomic studies have found that no known plastic-degrading enzymes are present in the public genomes of traditional probiotic species and next-generation probiotic species^[5], indicating that it is difficult for existing natural flora to effectively remove intestinal microplastics. How to design an efficient, safe, and universally applicable microplastic removal system for the human body has become an intractable problem.

The problems outlined in the pain points have also prompted reflections within our team. Building on existing probiotic research, we wondered: Could we independently modify microorganisms to endow them with plastic-degrading capabilities? Combined with our knowledge of diverse probiotic products, we conceived an idea: by integrating engineered strains with probiotic freeze-dried powder, these "engineered bacteria equipped with degradation "weapons" could act in the gut after users finish meals. This led to the design of our product—microplastic-degrading probiotic freeze-dried powder.

The iGEM NMU team has developed this probiotic project for food companies (represented by probiotic health product enterprises) and healthcare companies. The product can be widely used by almost all populations, especially urban residents (who are frequently exposed to microplastics via takeout and packaged food) as well as health-conscious elderly individuals and mothers of young children. Food companies specializing in probiotic freeze-dried powder offer extensive production and sales services worldwide, with "health" and "sustainability" being key highlights of their marketing. To enhance product competitiveness and brand image, these companies are willing to adopt new technologies to launch innovative products, making them open to investing in our product. Ultimately, they must agree to our safety and responsibility requirements and strictly adhere to them throughout the cooperation. For example, leading probiotic freeze-dried powder enterprises such as Culturelle, Bio-K+, Nutrilite,Herbalife are our primary target customers for future collaboration. Additionally, other small and medium-sized enterprises will also be our potential users.

We have analyzed the stakeholders from upstream (probiotic yogurt R&D laboratories and raw material suppliers), midstream (product factories and packaging companies), and downstream (sales channels and users), and made a flow chart.

Our product is suitable for almost all populations, especially urban residents (frequently exposed to microplastics via takeout and packaged food), health-conscious elderly individuals, and mothers of young children. These groups have a close connection with our product and are likely to be its biggest beneficiaries. According to our survey of target users (see Human Practices), they hold a positive attitude toward our product and recognize its potential value. Meanwhile, we will provide users with detailed and accurate usage instructions and recommendations to ensure the safe and effective use of the product.

Product name:Anti-plastic probiotic freeze-dried powder.

Product description:This product is a freeze-dried powder made from our modified engineered bacteria. As a health food, it can help people remove the microplastics that are difficult to be digested and absorbed in the intestines. It does this by secreting degrading enzymes and promoting the repair of intestinal mucosa, thereby reducing the harm of microplastics to the human body.

Edible methods:
(1) Take it with warm water: Prepare warm water at around 37℃. Pour an appropriate amount of the freeze-dried probiotics powder into the warm water, stir well and take it as soon as possible.
(2) Direct oral administration: Directly take the it into your mouth, and then swallow it with an appropriate amount of warm water.
(3) Mix with food: Probiotic powder can be taken by mixing it with certain foods.

(1) Advantages: Most of the current microplastic removal methods in the human body are “laxative” (Bisacodyl, polyethylene glycol). Polyethylene glycol solutions remove residual feces and particulate matter (such as microplastics) by increasing the osmotic pressure in the intestinal lumen^[6], while the stimulant laxative Bisacodyl removes microplastics by stimulating intestinal nerves to accelerate defecation, but it causes a series of side effects such as gastrointestinal cramps and cardiac dysfunction^[7]. After visiting communities and hospitals, our team found that most elderly people and children have very poor tolerance to "frequent diarrhea and electrolyte imbalance", and most patients want to relieve gastrointestinal diseases in a mild way, we are planning to design the engineered bacteria as a popular freeze-dried powder product to reach a wider audience. When the engineered bacteria reach the gut, they spontaneously recognize gut environmental signals, while the quorum sensing activation regulation is met, they express a large amount of degrading enzymes for the degradation of microplastics. This trait is beneficial for maintaining the number of engineered bacteria and therapeutic effects.

(2) Safety: Traditional laxatives can aggravate the loss of water and nutrients in the body, and can easily cause other high-risk diseases such as intestinal melanosis. They are not suitable for long-term use, and patients are resistant to this medical method and have poor compliance. However, using freeze-dried powder containing probiotics to remove microplastics from the human body has the characteristics of low irritation to the intestines and high safety. At the same time, an arabinose suicide switch was set up, and engineered bacteria spontaneously undergo apoptosis outside the human body, reducing environmental pollution. The product is double enveloped by the combination of ion-induced gelation and polyelectrolyte composite method. This structure can effectively resist the attack of gastric acid, and dissociate in the neutral environment of the intestine to achieve targeted release and avoid other damage. Our team conducted wet experiments to verify each module and established a model that fits the wet experiment results through dry experiments, providing assurance for the safety of engineering bacteria and reference for subsequent experiments.

(3) Innovation: The core components of many probiotic products have similar functions, with most focusing on "regulating gut microbiota", "relieving constipation",etc. There are few specialized probiotics that can target specific diseases or scenarios. Our plastic reducing probiotic freeze-dried powder overcomes the serious problem of product functional homogenization and has probiotics specifically targeting microplastics in the human body.

(1) Future applicability: The feasibility testing of biodegradable microplastic freeze-dried powder will be conducted in real clinical environments in the future. We will conduct interviews with patients of different ages and occupations after using the product, and compare the help of the drug to patients with the current mainstream treatment methods for alleviating diseases caused by intestinal microplastics. At the same time, we will continue to conduct experiments and continuously improve the product to achieve better flavor, quicker effect, and fewer side effects. We will focus on optimizing the production structure and controlling product costs so that patients can obtain a better experience at a lower price. Artificial intelligence will also play a significant role. They can assist patients in setting personalized dosing times and amounts.

(2) Increased market demand: The hazards of microplastics have received widespread attention in recent years, due to their stable chemical properties and resistance to degradation for hundreds of years. The harm to the environment and health cannot be underestimated. In real life, microplastics can be seen everywhere, whether in the food packaging bags, takeaway boxes, or even the air we breathe. Some scholars from Taiwan or Chinese mainland published research in the journal Nature Communications to clarify the complex interaction between plastics and the intestinal microenvironment, revealing the mechanism of its destruction of the intestinal tract. The accumulation of microplastics exacerbates the occurrence of gastrointestinal diseases and expands the demand for plastic reducing products.

(3) Policy and Development Pattern: After the COVID-19 pandemic, people paid more attention to gastrointestinal health. In 2021, the conference of "Probiotic Food" convened, which set industry guidelines for probiotic food, such as strain identification, live bacteria content, shelf life, and so on. Since then, the development of probiotic product industry has begun to standardize. The National Health Commission has published the "Healthy China Action - Implementation Plan for Environmental Health Promotion Action (2025-2030)", which mentions reducing the use of microplastics. The publishment of the "Draft for Comments on Formulations and Technical Requirements for Health Food Filing Products" and the "Draft for Comments on Available Excipients and Their Use Regulations for Health Food Filing Products" in 2024 marks the relaxation of policies on health food formulations, which can promote the development of the gastrointestinal probiotic powder industry as a health product, shorten the marketing cycle and production costs.

Porter's Five Forces Analysis Model^[8] was proposed by Michael Porter in the early 1980s for competitive strategy analysis.
There are five basic competitive strengths in industry competition. The strength of these five basic competencies determines the intensity of industry competition, which in turn affects the attractiveness and profitability of market structure, ultimately determining changes in industry profit potential. These five forces are: the bargaining power of suppliers, the bargaining power of buyers, the threat of new entrants, the threat of substitutes, and the competitive intensity of existing competitors. The changes in the combination of these five forces ultimately affect the profitability potential of the enterprise and determine the profitability of the industry. Porter's Five Forces are mainly used in fields such as market analysis, strategic planning, and investment decision-making. We will use this method to clarify our company's competitive advantages and disadvantages in the future.

Product Name: Biolution Probiotics

Production company：Bluepha

In recent years, the Bluepha has developed a solution that can help eliminate microplastics from the human gut ,the Bacterial Droplastic ™. After ingestion, probiotics in the intestine specifically adsorb microplastics, allow probiotics and microplastics to aggregate into clusters, while enhancing the intestinal barrier and preventing microplastics from entering the bloodstream. Experiments demonstrate that it can effectively eliminate the intestinal tract, effectively reduce intestinal inflammation, eliminate free radicals and effectively resist oxidation. This product demonstrates a promising market outlook. Due to the direct competition between their product efficacy and ours, we need to closely monitor the team and develop effective competitive strategies.

Product Name: Life Space Probiotic Powder

Production company: By-Health

The bifidobacteria and lactobacilli contained in Life Space probiotic powder can balance the harmful bacteria in the gut microbiota, thereby they can alleviate diarrhea, promote colon peristalsis, assist normal bowel movements, and aid the elimination of microplastics. Long- term supplementation of probiotics can repair microcirculation in the reproductive system and reduce the damage caused by microplastics to the human body. In addition, its activation of the immune system and enhancement of phagocytic cell activity also have a certain effect on clearing microplastics in the human body. But for probiotic brands, it belongs to a nutritional health product and does not have a standard therapeutic effect.

Product Name: Probio-Fit Probiotics

Production company: ScitopBio

Probio-Fit probiotics contain Lactobacillus casei Zhang, Bifidobacterium lactis V9, and Lactobacillus plantarum, which have the function of maintaining the balance of intestinal flora, improving intestinal problems such as constipation, bloating, and indigestion. The advantage is that it belongs to clinical probiotics, with experimental support for its functions, and has good therapeutic effects on ulcerative colitis and irritable bowel syndrome that may be caused by microplastics. Suitable for elderly people with weakened immunity, children, and athletes who strictly control their diet, but its disadvantage is that it only treats the symptoms rather than the underlying cause. It can only alleviate the adverse effects of microplastics in the short term.

(1) Market Development Analysis: Microplastics have posed a significant threat to human reproductive health, as their presence can lead to inflammation, intestinal epithelial damage, intestinal barrier disruption, and dysbiosis of the gut microbiota^[9]. In addition, microplastics can accumulate in the fetus^[10], cause a 42% decrease in male sperm motility^[11], posing a threat to human reproductive health. It is predicted that by 2050, the amount of microplastics consumed per person per year will increase nearly tenfold^[12]. From intestinal discomfort to the frequent occurrence of various diseases throughout the body, microplastics have escalated into a global health challenge that concerns human survival. At present, Southeast Asia, Europe, and some regions in the Americas have a high intake of microplastics in the air and diet^[13].

In China, microplastics, along with persistent organic pollutants, endocrine disruptors, and antibiotics, are known as the "four major families" of new pollutants. Start from 2024, mainstream media will begin to focus on reporting on the detection of microplastics in multiple organs of the human body. The public's active search for "clearance/detoxification" has significantly increased, and the attention to intestinal health has also significantly increased. People are increasingly inclined to adopt an active lifestyle to alleviate the harm of microplastics to the gastrointestinal tract. Probiotic health products, as a convenient and feasible method, are gradually being recognized and accepted by the market. Currently, there is no real health product targeting microplastics in the human body in China, making the market for biodegradable microplastic freeze-dried powder huge.

(2) Market size analysis: Chinese probiotics for regulating gastrointestinal function are currently in a steady growth stage. From 2019 to 2024, the market size of probiotics for regulating gastrointestinal function in China increased from 17.51 billion RMB to 30.14 billion RMB, with a compound annual growth rate of 12.14%. It is expected to increase from 33.69 billion RMB in 2025 to 38.12 billion yuan in 2029, with an annual growth rate of 3.14%. Due to the increasing living pressure and health problems faced by contemporary Chinese residents, the demand for maintaining gastrointestinal function is constantly driving the penetration rate of probiotic products in the market, which is steadily increasing from 106.57 million people in 2019 to 109.44 million people in 2023^[14]. At the same time, technological advancements have led to continuous innovation and upgrading of products to expand the market size of gastrointestinal probiotic products.

(3) Market Environment Analysis: Social environment: With people's attention to issues such as intestinal health and immunity, gastrointestinal probiotic freeze-dried powder, as an important component of health food, continues to expand in market demand.

Technical environment: The continuous advancement of biotechnology has significantly improved the production process of probiotic freeze-dried powder. For example, the optimization of freeze-drying technology not only saves costs and extends the shelf life of products, but also maintains higher activity of probiotics during the freeze-drying process, improving product quality.

Policy environment: In 2019, the State Administration for Market Regulation issued the "Regulations on the Application and Evaluation of Probiotic Health Foods (Draft for Comments)" to promote the establishment of a quality assurance system, urging enterprises to strictly control quality in the production process and ensuring the safety and effectiveness of products;In 2022, the National Health Commission formulated the "14th Five-Year Plan for Food Safety Standards, Monitoring and Evaluation, and formulated technical guidelines for risk assessment of nutrients and nutrition related substances to enhance consumers' awareness and trust in probiotic products;The "Implementation Rules for Technical Evaluation of New Functions and Products of Health Food (Trial)" issued by the State Administration for Market Regulation in 2023 provide clear technical evaluation standards and regulatory requirements for the probiotics industry for gastrointestinal function regulation, promoting the research and market access of new function probiotics products in the industry.

In order to successfully bring our engineered bacteria to the market and achieve industrial production, we have designated a series of plans and steps to advance.Firstly, thorough market research is the first step towards success. Market research can help us gain a deeper understanding of demand and discover potential users. Through in-depth research, we can grasp the market dynamics in real time, understand competing companies to enhance our competitive advantage, and attract suitable partners to obtain sufficient financial support.

The development and optimization of production technology play a crucial role, and we have improved the seeding tank for expanding bacterial strains. Considering the shortcomings of the existing seeding tank, such as inability to control constant temperature, easy generation of bubbles during the process, and potential hygiene blind spots during cleaning, we have made improvements to the seeding tank¹⁵. By using a motor to pull the stirring rod, it can move up and down, allow the bacteria to more fully contact nutrients and grow and reproduce faster and make it easier to clean dead corners; Built in bubble breaking device to reduce the number of bubbles in the tank; There is a constant temperature device outside the fermentation tank, which can strictly control the fermentation temperature. The traditional freeze-drying process requires a long pre-freezing process, which can easily damage the bacterial strains. We have referred to the continuous liquid nitrogen granulation technology developed by Turking company to quickly freeze the liquid that needs to be freeze-dried into uniform particles, greatly improving the viability of the bacteria.

The role of cost control should not be underestimated. In the processing of probiotic powder, there are various procedure such as strain recovery, strain expansion, centrifugal concentration, emulsification embedding, freeze-drying, processing and packaging, comprehensive quality inspection, etc. We will consider multiple aspects such as economic benefits and product quality, and provide high-quality probiotic freeze-dried powder while maintaining low cost. Here is our cost analysis considering multiple aspects:

A comprehensive understanding of relevant laws and regulations is a prerequisite for our enterprise to achieve excellence and growth. We should ensure that our strains and production processes comply with current policies and regulatory requirements, and conduct safety and quality inspections to ensure market access. And utilize beneficial policies and regulations to build our enterprise better.

Once we gain market access, we will continue to promote the industrialization of production and optimize our marketing strategy, promote our products through TikTok, WeChat official account and other platforms, find partners with more commercial value, and show our technology and goals to the outside world by organizing exhibitions, issuing enterprise white paper and other ways.

Before officially entering production, we will actively seek advice from relevant experts and obtain profit models for related technologies as well as other commercial suggestions. We will prepare corresponding materials, including experiments that have been conducted, experimental principles, technological innovations, and competitive advantages compared to similar products in the market, to apply for patents so that we can protect our innovation. At the same time, we will register trademarks for our products, complete Madrid registration, and use the trademarks to enhance market recognition. We will also register the experimental data and packaging design with the Copyright Office, and keep the complete creative evidence chain to prevent others from copying.

Through in-depth research and innovative design, our team has developed this probiotic product and will enable its practical application in daily supplements such as freeze-dried powder. This product can effectively remove harmful microplastics from the gastrointestinal tract, providing strong protection for human health. We aspire to build a broad and trustworthy brand image and become the preferred probiotic product provider for consumers, enterprises, and even governments.

The NMU-China team is composed of a group of aspiring young people with a strong sense of social responsibility and innovative spirit. The team has a detailed division of labor, and each member has made significant contributions to this project in their respective professional fields, including biological experiments, mathematical modeling, product design,entrepreneurship, human practices, web production, and art design. At the same time, team members fully communicate and cooperate,constantly promoting our project. Through countless collisions of ideas, our project has gradually produced results and moved towards the market from a small idea. As a united and efficient team, we have a tight organization, each with their own strengths, and we are meticulous, rigorous, lively, and cheerful. This plays a crucial role in our innovation ability and team management. In the future, we will continue to work hard! In addition to our own strong capabilities, the team also has powerful social resources. We have received guidance, suggestions, and strong support from many teachers from the Department of Life Sciences of Fudan University, Zhejiang University, and various medical colleges, as well as a series of suggestions and help from stakeholders in human practices. Thank you for their trust and dedication! In general, NMU-China has the professional capabilities and external support required for entrepreneurship. We will continue to work hard to optimize ourselves and become a trustworthy partner!

To implement our entrepreneurial plan, we have formulated a financial plan and a fund plan:

(1) Fund Sources:

① Early Stage: In the early stage, we will focus more on seeking academic and scientific research funds, concentrating on the R&D and upgrading of the core technology of the product to ensure the innovative leading position of this technology. We plan to cooperate with universities and start-ups to ensure the supply of early funds, and establish long-term cooperative relationships with suppliers and sponsors to obtain necessary resources and support and reduce research costs. At the same time, we will also try small-batch OEM production and verify whether local supermarkets and online e-commerce platforms are reliable sales channels to ensure that we are on the right path.

② Mid-Term Stage: With the support of early sponsors and suppliers, we will have completed the preliminary R&D and production of the product in the mid-term stage. Subsequently, we will participate in entrepreneurship competitions such as the "China Innovation and Entrepreneurship Competition (Big Health Track)", attract investors by demonstrating the product's characteristics and commercial potential, and support the continuous upgrading of the product and more entrepreneurial plans. At the same time, we may also actively participate in competitions held by government medical sponsors, which are aimed at projects with innovation and commercial potential. By participating in these competitions, we may obtain financial support.

③ Late Stage: We will actively seek corporate investment to support the further iterative R&D and commercial promotion of the product. We will formulate a detailed financing plan, specifying the use of the required funds and expected returns. We will also actively seek opportunities to communicate with potential investors through social media, academic conferences, business activities, industry networking, and business contacts. We will provide investors with detailed plans and profitability analysis to establish business trust and seek business opportunities. At the same time, we will actively demonstrate the commercial potential and competitive advantages of our product in the market, emphasizing its unique innovation and academic background to attract more investors.

(2) Fund Allocation:

① 50% will be used for product iterative R&D: After the product is launched on the market, we need to continuously optimize and upgrade it according to market feedback and demands to ensure the product's competitiveness and market value. We plan to use this fund for market research and product development: the former helps to gain a deeper understanding of customer needs and market trends, while the latter ensures that our product is updated in a timely manner to maintain a competitive advantage at all times.

② 30% will be used for marketing: To attract users and investors, we will create a creative and impressive brand image, and establish effective marketing channels based on the brand, including online advertising, social media, and content marketing, to increase brand awareness, attract more potential users and investors, and expand the market. At the same time, we will stimulate users' willingness to purchase the product through promotional methods such as discounts, gifts, and product launch events to promote our product in the market.

③ 20% will be used for business development: We need sufficient funds to hire professional teams, including R&D personnel, sales experts, and management personnel. This fund will be used for efficient team management, various human resource costs of the company, and the renovation and maintenance of production equipment. At the same time, we will hire product consulting experts to obtain valuable professional advice on product design, user feedback, and market positioning.

At present, our business plan is still in the initial stage of planning and implementation. We have conducted the following SWOT analysis on the resources required for future development, potential risks, and positive/negative impacts: