Overview
With our Shanghai High School International Division iGEM team being a long-standing presence for many years, we've always aimed to address critical global challenges through synthetic biology. However, the focus on IBD (Inflammatory Bowel Disease) became personal and urgent when one of our team members from last year was diagnosed with this condition. His experience has driven us to dedicate more effort to finding effective solutions for this increasingly prevalent but still somewhat mysterious disease. This year, we're concentrating on the growing global demand for IBD treatments, particularly in rapidly developing countries like China. Our mission is to develop IL-BP18 (Interleukin-18 Binding Protein) tablets, which can prevent intestinal inflammation by binding to and neutralizing Interleukin-18, a key proinflammatory cytokine. By engaging with stakeholders, including patients, healthcare professionals, and pharmaceutical companies, and securing funding through iGEM-related grants and biotechnology competitions, we aim to ensure that our solution meets the scientific and regulatory standards and addresses the real-world needs and concerns of IBD patients.

Questionnaire
Introduction
In order to deeply understand the current public awareness of Inflammatory Bowel Disease (IBD) and the patient's understanding of IBD disease treatment, we designed a questionnaire and distributed it on the questionnaire platform. Finally, 386 responses were obtained. The questionnaire was structured to examine the impact of age, geographical location, and economic background on individuals' understanding of IBD and different associated risk factors. This approach facilitates the identification of critical knowledge gaps and highlights areas where targeted awareness initiatives are necessary. The majority of respondents were concentrated within the under-18 and 45-55 age cohorts, with 341 participants residing in prominent urban centers such as Beijing, Shanghai, and Guangzhou.
Part 1-Background Information

Figure 1: The distribution of age

Figure 1 to 4 ask for the basic background information of participants. From the graph above (Figure 1), it is evident that most of our participants are 45-54 years old, followed by those under 18 and those 25-34 years old. IBD occurs most often in people around 45-54 years old; however, there is an increasing amount of data supporting the rising probability of teenagers being diagnosed with IBD. The reason for this phenomenon could be explained using the data gathered in Figure 5.


Figure 2: Resident area

According to Figure 2, most of the participants live in Beijing, Shanghai, Guangzhou, and Shenzhen. The data recorded in this questionnaire requires us to consider how living in first-tier cities might affect an individual’s risk of being diagnosed with IBD.

We asked “How familiar are you with synthetic biology?” and the average point was 1.93. Participants were asked to rate their familiarity with synthetic biology on a scale of 0 to 5, where 0 means “I know nothing about it” and 5 means “I am very familiar with the subject.” The average score was 1.93 out of 5, indicating that most participants have limited knowledge or awareness of this field. This score is significantly below the midpoint of 2.5, suggesting that synthetic biology is not well-known or understood among the surveyed group. This could imply that, despite its growing importance in scientific and medical research, synthetic biology remains a niche area that has not yet permeated mainstream knowledge or education.

For the question “How familiar are you with genetic engineering?” about genetic engineering, the average score is 2.07, which is slightly higher at 2.07 out of 5. While this suggests a marginally better understanding of genetic engineering compared to synthetic biology, the score is still low, indicating that most participants have only a basic or superficial understanding of the topic. This slight increase in familiarity could be attributed to broader public exposure to genetic engineering concepts, such as discussions about genetically modified organisms (GMOs) or gene therapy in the media.

The low familiarity with both synthetic biology and genetic engineering underscores the need for increased public education and engagement. This suggests that our team should focus on creating more advertisements and posters to raise awareness and inform the public about these important fields.

Part 2-Personal Health Conditions

Figure 3: Diet of Participants

Diets high in processed foods, fats, and sugars might contribute to the onset or exacerbation of IBD by altering the gut microbiome and promoting inflammation. Conversely, most participants report having a mild and light diet, which can be beneficial for preventing IBD. However, 32.88% of participants consume meals where at least 40% is meat, indicating a high-protein diet. Given that the majority of participants are under 18 or between 45-55 years old, we can interpret the data as follows: those under 18 are the primary contributors to the high-protein diet group, while those aged 45-55 are more likely to have a mild and light diet. This could explain the increasing probability of IBD diagnosis among the under-18 group, as their high-protein diet may contribute to the exacerbation of IBD.


Figure 4: Habits/symptoms

Up to 58.55% of participants reported none of the mentioned symptoms, while 41.45% did exhibit some of the symptoms. Among those with symptoms, the most prevalent are living in a high-pressure environment and experiencing recurrent gastrointestinal discomfort. Prolonged exposure to anxiety and stress can undermine the immune system, increasing the risk of IBD. This finding highlights the prevalence of gastrointestinal discomfort in everyday life and reveals how common harmful habits might contribute to various diseases, including IBD.

Participants who chose “I don’t have any of the above symptoms/habits” were directed to answer Questionnaire A (Figure 5-8), while those who selected any of the given symptoms proceeded to Questionnaire B (Figure 9-14).


Questionnaire A

We asked the participants, “How familiar are you with IBD?” and asked them to rate their familiarity on a scale of 5. The average recorded data is 1.68. People are aware of IBD, but most people are not familiar with IBD. This should be kept in mind when analyzing this questionnaire.


Figure 5: Receptiveness of learning more about synthetic biology and its application in the treatment of diseases such as IBD

Up to 84.52% of participants are willing to learn about IBD. Within, 47.35% of participants are willing to learn depending on the context. This percentage provides a positive response from the participants, highlighting that most people are willing to learn about IBD.


Figure 6: Preference for receiving educational information about synthetic biology and IBD

Social media has become a powerful tool for spreading information. It has become more popular in recent years for educational purposes due to its accessibility. As expected, most people prefer to learn about IBD knowledge online. 66.81% hope to learn about IBD through videos and documentaries, and 53.54% want to learn information using online tweets or blogs. However, only 18.58% of participants want to learn using online courses. Then, we get the idea of using the social media and internet to present and spread knowledgeable posters and blogs.


Figure 7: Preference for educational content complexity

62.39% of participants hope to learn contents that are very easy to understand, followed by medium difficulty (20.8%), depends on topic (11.95%), and esoteric and scholarly (4.87%). From this, we understand that we will make the content easy and simple for understanding.


Figure 8: Where participants receive information about health and science

Most people obtain information about health and science from videos, documentaries, and online tweets and blogs. Additionally, many participants mentioned “小红书” (Xiaohongshu) as a useful platform for learning and receiving knowledge.

Questionnaire B

Figure 9: Diagnosis of IBD

In this questionnaire, 4 participants are diagnosed with IBD. The 2.42% prevalence of diagnosed patients indicates that IBD is more common than typically expected and occurs within our community.


Figure 10: Factors considered when choosing a drug to treat intestinal disease

As expected, most participants prioritize treatment effectiveness and potential side effects when choosing a drug for intestinal disease. Fewer participants consider medicine accessibility, which may be attributed to the fact that most respondents are from first-tier cities, where access to medicine is generally less of an issue.

To address this observation, our team will focus on enhancing treatment effectiveness and minimizing potential side effects. Additionally, we will emphasize these two aspects in our public promotions to demonstrate how our medicine addresses these key concerns.


Figure 11: Acceptance of using a new protein drug made using synthetic biological methods for anti-inflammatory treatment

Synthetic biology holds promising potential for anti-inflammatory treatments. According to the data, 27.88% of participants indicated that they would consider using modified protein drugs, while only 6.06% would not consider them. Given the low familiarity with synthetic biology among participants, as revealed in questions from part 1 (questions asking for familiarity with related scientific topics), it is notable that 50.3% of participants are open to possibly considering a new protein drug.

With increased information provided through social media and the internet, we anticipate that the number of people willing to consider using a new protein drug developed using synthetic biology methods will likely increase.


Figure 12: Main concerns about new anti-inflammatory treatments (Table)

Figure 13: Main concerns about new anti-inflammatory treatments (Bar graph)

Participants are primarily concerned about potential side effects, uncertainties regarding treatment efficacy, and the lack of data on long-term safety. We will address these concerns by providing clear explanations of how we plan to manage and mitigate these issues.


Figure 14: Acceptance of drug-usage frequency

Most participants (62.42%) prefer to take medication as needed. A higher number of people prefer taking medicine once a day, while fewer prefer a weekly regimen. This preference may stem from the belief that daily medication provides more consistent efficacy. Daily medications are also more common on the market and are more frequently used by patients, which may explain the preference for daily dosing.

One participant commented, “As little as possible.” By enhancing the efficiency of the medication, patients could potentially reduce the frequency of intake, thereby minimizing side effects and avoiding physical dependency.

Reflection

The questionnaire highlighted critical areas for our project development. The low public familiarity with synthetic biology and genetic engineering (scores of 1.93 and 2.07 out of 5) underscores the need for increased educational outreach. Our communication strategy should leverage social media and digital content to raise awareness. Additionally, dietary and lifestyle factors impacting IBD risk suggest incorporating preventive advice into our educational materials. The positive openness towards synthetic biology-based treatments (27.88% willing to consider) indicates potential acceptance, but concerns about safety and efficacy must be addressed transparently. These insights will guide us in tailoring our educational content and addressing public concerns to enhance the impact of our project. For more details, please refer to our EDUCATION section

Interview
Interview with Ms. Cheng Lu
Stakeholder’s background

Ms. Cheng Lu obtained her degree from the esteemed Hubei University of Medical Science in 2003. She has extensive expertise in both the clinical application of Western and traditional Chinese medicine. Over the years, she has held various positions in the Pharmacy Department at the Hospital of Wuhan Institute of Technology, progressing from Pharmacist to Deputy Director and ultimately to Director.


Figure 15: Interview with Dr. Cheng Lu
Stakeholder’s View
1.What is IBD?

The professor first informed us about the basics of IBD. IBD can be divided into Crohn’s disease and ulcerative colitis, both of which are characterized by abdominal pain and diarrhea. Crohn’s disease is an infection of the conjunctiva of the digestive tract that may exist throughout the digestive tract. Ulcerative colitis specifically refers to the inflammatory changes of the mucous membrane of the rectum and colon.

2.How is IBD developed nowadays and why is it important?

First found in Europe and America, where the daily diet has the characteristics of high oil, high sugar, and few grains/vegetables, IBD has recently spread to eastern China as the living standards increase. IBD is not contagious, and does not have a definite cause. However, as IBD is especially common in modern developed cities, it is reasonable to say that a structural change of eating habits plays a vital role in the cause of IBD. As IBD can only be relieved instead of cured, it is currently categorized as one of the chronic diseases. Also, since severe IBD will cause bowel cancer, which is one of the most undetectable cancers in the world, finding ways to relieve IBD quicky has become a major concern.

3.What are some current treatments for IBD? Why are these treatments preferred?

The professor then discussed about several ways of treatment in different conditions. The milder treatment for IBD——also the most widely used ones in the clinic——are anti-inflammatory drugs, such as sulfasulazide, such as methalazine, which are cheap (about 100 yuan). Secondary treatments include anti-inflammatory drugs like immunosuppressants, making inflammatory cells unresponsive to structural changes in the colon. Through these therapies, the hemolytic symptoms of abdominal pain can be controlled, while the side effect of suppressing the immune system damages inflammatory cells. If the patient relies too much on drugs, biologics should be introduced to provide a faster, more precise and more effective treatment with fewer side effects. However, using biologics comes with a really high price (about 2000~5000 yuan) and cannot be used if the location of inflammatory tissue is unsure. Some of the most widely used biologics repress Interleukin (IL1~18), especially Inflizumab that represses Interleukin-6 that is already approved in China. Some unapproved drugs that is also effective in relieving symptom includes Interleukin-17 that is developed by United States and Interleukin-12 that is currently developing.

4.Specifically, what procedures should the treatment follow?

The professor then specifically introduces the process of treatment. For the frequency of medication, hormones should be used for at most 7 days to test its effectiveness; Immunosuppressant takes two or three months to show its effectiveness; as a biological agent injection, monoclonal antibody should be used six times a year, following a “024888” order, that is, the second dose will be taken two weeks after the first, the third dose four weeks after the second, and so on. If the six doses also do not work, other treatments such as interleukin-17 may be needed.

5.What are some important points that need to be focused during the treatment?

Aside from the information mentioned above, the professor also mentions that infections such as staph aureus infection are common in clinical treatment. Severe infection will cause complication syndromes, which will greatly increase the mortality rate of the case. On the drug-engineering side, the professor also gave some precious advice: She recommended injection instead of taking the drug orally, and informed us that milder drugs are more likely to be used on IBD since stepped-care approach is used in IBD treatments nowadays.


Discussion and Reflection

This interview has provided us with a great opportunity to talk directly with an experienced professional pharmacist. As our aim is to develop a drug that is effective and economical that can be used to treat IBD, her advice is extremely valuable in both of our work in dry and wet team. Aside from the latest developments and treatments informed by the professor, one of the most compelling fact that we have learned throughout the interview is that subcutaneous injection is always preferred rather than pills and capsules that are taken orally. In fact, our team ran into a discussion after the interview about whether we should change our product into an injectable drug. Balancing the opinions, we finally concluded that a gastric-acid-blind capsule would be the best solution since it can directly reach the focus of the disease and is way more convenient than injections. On the dry-team side, the introduction of stepped-care approach also inspired us to improve on our work, making it more attractive to both developers and patients.


Interview with Dr. Wang Dongfeng
Stakeholder’s Background

Figure 16: Interview with Dr. Wang Dongfeng
Stakeholder’s View
1. The treatment of IBD and some challenges

To Begin with, this interview aims to learn more about treatment options for inflammatory bowel disease (IBD) in the emergency department, interdisciplinary collaborations, and explore current challenges and room for improvement. Through the following questions, we hope to gain a comprehensive understanding of the actual experience of emergency department physicians in dealing with IBD, the challenges they face, and interdisciplinary collaboration. Through this interview, we hope to reveal the strengths and room for improvement in the management of IBD in the emergency department to promote further development of the field and optimize patient care.

We first asked the stakeholders about how to identify IBD. The stakeholder states that abdominal pain and bleeding are the most common emergency patients with IBD. However, diagnosing IBD is still the biggest problem of the treatment. The stakeholder uses techniques such as abdominal CT, urine test to identify IBD. Another major challenge during the treatment is that some patients may have stomach perforations, which is deadly since the bacteria will leak into the bloodstream.

2. Some thoughts about our project

Then, we discussed whether our design may be helpful in the treatment of IBD. The stakeholder suggested that since immunosuppression is very targeted, IL-18 will become a potential substance that can be helpful. However, he also states the fact that only a small fraction of the drugs can be directed to where they are needed, so an anesthetic colonoscopy should be included every time. Also, stomach acid and small intestine may cause the protein to deteriorate. Hence, a capsule should avoid being broken down before it reaches its destination.

The stakeholder also made some further suggestions at the end of the interview. Although saying that our topic is innovative and practical enough, he thinks that a suitable type of E.coli strain should be selected as the carrier of the central nuclear expression system in the project to avoid or minimize other toxic or sensitizing proteins while synthesizing IL-18BPFC, ensuring the safety of the drug as much as possible. We should also ensure that there is a good purification effect in the later stage of production, and avoid the interference of other proteins in the injection, leading to allergic reactions or other adverse reactions. Targeting guidance should also be included to keep the waste of drugs as few as possible.

As another option for the product, the stakeholder designs an active solution enema dosage form and sprays it into the diseased area (colon, including the end of ileum) for administration under direct observation by colonoscopy, with the strongest targeting and the highest local drug concentration; However, the disadvantage is that every time the drug is administered, it requires the use of colonoscopy and even anesthesia.


Reflection

After the interview, we did not only learn a lot about IBD and some ways to improve on our ideas, but also some new ideas to bring our project to a higher level. Our current task this time is to bind interleukin 18 downstream, that is, after it has been synthesized, to inactivate it to lower the level of inflammation; but we can also think upstream of this process, which is interfering with IL18 synthesis: making the right protein or iRNA, interfering with the part of the DNA chain involved in IL-18 synthesis, directly reducing interleukin-18 synthesis at the source, to reduce inflammation, to treat IBD; We can design and synthesize an endonuclide (also a protein), which can selectively cut one or several fragments of interleukin-18, causing its inactivation or even disintegration to achieve therapeutic purposes.


Interview with Ms. Kong Yangyang
Stakeholder’s Background

Ms. Kong Yangyang is a researcher at Chengfan Pharmaceuticals. She has a master's degree in Bioengineering from the University of Chinese Academy of Sciences. She is currently employed at a unicorn innovative pharmaceutical company in Shanghai, which is specialized in researching and developing various types of antibody drugs, including nanobodies, bispecific/multispecific antibodies, ADCs (antibody-drug conjugates), and naked antibody production.


Figure 17: Interview with Ms. Kong Yangyang
Stakeholder’s View
1.Thoughts on IBD treatment field

IBD is a nonspecific chronic disease that differs from conditions like tumors and falls under the category of autoimmune diseases. The global market for IBD is very substantial, for there are about 6 to 8 million patients worldwide. It is projected that in the future, this market will reach $4.9 million. This indicates strong market potential and promising expectations. For IBD patients, when choosing medical treatments, they may consider its method of drug administration, medication cycle, and price. Currently, there are no medical treatments that can cure IBD enduringly. After taking the same medicine for a period of time, the patient may tolerate to the drug and need to take another medicine. Also, the specific cause of IBD is very complicated, so it is difficult to find precise drug targets. Additionally, the current clinical trial models are not efficient enough. Recently, the CAR-T cells and bispecific antibodies may become emerging trends in the development of IBD treatments.

2.Experience of being an iGEMer

We also inquired about iGEM medals and projects, as Ms. Kong is a former iGEMer. She shared that when evaluating awards, the judges will look at the contents of each group's wiki and promotion video. Later, they will ask questions accordingly during the defense. In previous years, they also evaluated a few projects that are also related to IBD. Some of them focus on diagnosis through instrument-based measurements. However, Ms. Kong thinks the instrument is not effective and practical enough. The other ones focused on medical therapy where they produced a pill.

Reflection

After the interview, we had a better understanding of the field of IBD treatment since she has experience in those area. We also had a brief view of the future trends in this field, which are CAR-T cells and bispecific antibodies. This helps us to enhance our product and provides a direction for our experiment that we can follow. On the other hand, Ms. Kong’s perspective on the previous IBD-related projects helps us to improve our projects for she pointed out where the previous groups did well on and where they should not do.

Interview with an IBD patient-Mr. Li Jiawen
Goal: To understand the patient’s experience from the diagnosis of IBD, to how he copes with it in his daily life. The interview will show the significance of this project that might relieve IBD patients’ physical pain and economic stress.

Figure 18: Interview with patient
Stakeholder’s View

Mr. Li has been diagnosed with ulcerative colitis, one main kind of IBD. He describes his symptoms: hematochezia, frequent urge of discretion, feeling of tumescence in the rectum, unable to stand for too long (20 minutes at most), pain in rectum.

Recommended treatment: Mr. Li is recommended to use biologics as considering the severeness of his symptoms, the specific medication is vedolizumab and infliximab, first Mr. Li used vedolizumab for two months, after 3 courses, the symptoms endured, therefore, the patient changed to infliximab, and continued this treatment as this medication shows positive effect.

Side effects of the treatment: anorexia, weakened immunity, reduction in liver functions if using the medication in the long term. The endocrine used as assistance to stimulate the effect of biologics also causes an increase in glucocorticoids that affect skin function. As a result, pimples appear on the patient’s face.

IBD’s effect on the patient’s daily life: When IBD is active, Mr. Li is unable to perform daily activities, such as standing straight, walking, working, etc. Mr. Li has to stay in the hospital for at least 1 month. When IBD is inactive, the disease generates little effect on the patient, the patient could perform regular activities.

Unsatisfactory part of the treatment: using biologics required him to go to hospital frequently, causing inconveniences, it would be much better if the medication is in the form of capsules. The process of diagnosis is slow and complicated, the hospital could improve on diagnosis of IBD. 

Summary

The patient describes his inconveniences in his daily life with IBD, the symptoms and the how he used medication to retain remission, the medication and treatment he used and the corresponding side effects. All in all, this interview manifests the difficulties of living a normal life as an IBD patient, the treatment of IBD, and the possibility of the medication’s improvement.

Inspirations

This interview with Mr. Li provides us a glimpse into the daily life of an IBD patient, which motivates us to start this project, using IL-18 to produce an effective, economical, convenient treatment for IBD patients. The sharing of Mr. Li’s experience will continuously drive us to approach our goal. His reflection of IBD treatment, such as the form of medication, inspires us to set our final form of IBD medication in capsules, we believe if the medication can be taken in oral administration, it will be much more convenient and practical for IBD patients, which relieve them from frequent visits to the hospital. This interview gives us a precious experience, that will persistently inspires us to reach our goal.


Interview with a patient and his family
Stakeholder Background and Our Goal:

James is a rising senior currently studying at Shanghai High School International Division. He was diagnosed by IBD 2 years ago and is currently undergoing a therapy. His mother will also join the interview, providing different perspectives.

This interview aims to explore the emotional, practical and relational experiences of supporting families with IBD, providing insight into the broad impact of the disease on family life.


Figure 19: Interview with patient and his family
Stakeholder’s view
1.IBD’s influence on the patient’s family life

James suffered from diarrhea, intestinal obstruction, and abdominal infection about two years ago. However, these symptoms do not affect the patients severely at the start. After two months, when the symptoms became more extreme, the patient finally made a visit to the hospital, and was immediately diagnosed with IBD. After some brief anti-inflammatory operations, the experienced doctors advise patients to take biological agents directly due to the severity of the condition. The patient does not realize the severity of the disease at first, hence, diagnosis has an impact on the psyche of everyone in the family. Since the disease lasts a lifetime, patients do a lot of research on their own. The patient soon went to see a psychologist, believing that there was a high probability of depression after being diagnosed with IBD. When the patient was just diagnosed with IBD, his diet did not change much, but after going to the United States, he found that a healthy diet and rest are very important. Academic stress also affects the severity of IBD. As time goes on and more is known about the disease, things changed a lot.

To be more specific, the patient’s sleep schedule, diet, stress management need to be considered: the patient needs to be living like 70 years old. The symptoms of IBD are shown continuously and gradually, causing the patient unable to focus. Hence, the patient is no longer able to have high academics efficiency like he did before. Moreover, the patient is currently taking the IBDP course in school, which requires a lot of efforts. Since lots of academics need to be cut off, the patient’s parent is worried about whether the patient can handle the disease along with the curriculum.

Adjusting diet is also a huge challenge for the patient because IBD, unlike other diseases, does not have a completely confirmed diet. Hence, the diet should be both nutrient-rich and safe so that the symptoms won’t get more severe. In addition, there are many IBD treatment drugs have weak efficacy, the time of medication is inconvenient, how to eat, take medicine, and whether the therapy can be effective is still completely unknown.

2.The advice for other patients

Since the patient said that he did lots of researches on IBD, we then asked about his advices for other families who had just been diagnosed with IBD. James suggests that although his doctor recommended using biologics immediately, each patient will have a different condition and it is important for the patients to follow the instructions. The patient does not recommend changing the drugs actively, since his condition fluctuates during a drug change. Only change if the drug does not work anymore. The patient also notes that relieving the symptom requires a lot of self-control, since the patient needs to change their lifestyle completely.


Reflection

During this interview, James provided many details (not mentioned above) that specifically portray his process of treatment. This provides us with some new inspirations and limitations. We notice that the patient is having problems with balancing the times of taking food and drugs. If our product can be taken along with the food (since it’s a capsule), this problem can be solved. The patient also mentions that everyone will have a unique diet. Hence, to make sure that our product is suitable for most of the patients, the component of the capsule itself should be reconsidered. The most compelling fact we learned through the interview is that active drug change will have a negative impact on the condition. This means that our product should also consider the adaptation ability if it is used as an alternative choice for the patient. The durability of the drug should also be taken into account to avoid further fluctuation of the condition.

Field trip: Bluepha
Company background:

Bluepha is a synthetic biology company dedicated to make 100 project in order to benefit mankind. Right now, they are focusing on their project of using synthetic biology to make PHA plastic with suitable bacteria. PHA is the only bio-degradable plastic. Bluepha collaborated with Tsinghua University, Beijing University, Harvard University, and the Chinese Academy of Science. Their company is one of the only companies that provides mass production of PHA in China, and one of the top 5 mass producers of PHA on this Earth. Their product (small particles of PHA plastic) is made into all kinds of products such as plastic bags, art, straws, 3D printing material, and flavoring.


Figure 20: Visit the Bluepha
Company visit process:

We were taught about their company’s unique business model. Bluepha separated Research & Development into two segments: the Bacterial/cellular platform, and Industrial platform. The first platform’s main goal is to develop the cells/bacteria that will be used in synthetic biology, and the second platform is used for the development of mass production methods of cells/bacteria or proteins. Using this business model, their productivity increased by 300 times compared to when they were not using this business model.

After acknowledging their business model, we visited their production line, which first starts with a cell/bacterial development laboratory. After developing a successful and productive colony/sample, it’s separated into 3 7-liter fermentation/growth flasks, which separately raise the bacteria/cells in suitable conditions. After raising them separately, the most productive colony/sample is selected and mass-produced. The cell membranes and cell walls of the bacteria/samples are broken, and the product is extracted. Then the product is tested out (eg: make PHA into a plastic bag), and ready to be sold everywhere. Finally, Bluepha redoes R&D all over a gain once in a while in order to renew and improve the productivity of the colony/samples.


Figure 21: Interaction with Bluepha

After that, the company’s senior members provided valuable feedback and suggestions. They recommended conducting an in vitro ELISA test to evaluate our product's effectiveness in obstructing inflammation. Specific advice included separating the gene configuration Sumo-IL18BP-Fc into Sumo, IL18BP, and Fc on SnapGene for clarity, using a Sumo-specific enzyme to remove the Sumo protein from IL-18BP after E. coli lysis, and considering the use of yeast instead of E. coli for future mass production. Additionally, they suggested incorporating enzymes that release IL-18BP in the intestines by breaking open the capsule after a certain period, emphasizing in our marketing that IBD has a high infection rate and is incurable, exploring other indicators of IBD for future research, and strictly avoiding any actions that require copyright or royalties by keeping the product within the lab and preventing it from coming into contact with any organisms.

The seniors also provided some valuable insights of our experiments and product design. They suggested that an ideal promotion video for an iGEM competition should avoid using maps, flags, or political values, and should feature free music and original video footage that is eye-catching. When asked about the time required to return the investment after the product enters the market, the response indicated that it could take an extremely long time, depending on drug approvals and public acceptance, noting that even their PHA project has not yet seen a return on investment. To prepare the production line and inventory management, it is recommended that the process starts about three years before the drug hits the market. Regarding investment, it was suggested that 1,000,000 RMB is needed for angel/seed investment, 10,000,000 RMB for agreement/VAM, and 500 million RMB for Series-A funding.

Conclusion

We conducted integrated human practice activities with various stakeholders, gaining valuable insights that will shape our project’s direction. In response to the low public awareness of synthetic biology and IBD, particularly among young people in China, we will prioritize educational efforts through social media. Additionally, from the interviews, we gained a deeper understanding of IBD treatment preferences and future trends, such as the preference for gastric-acid-blind capsules over injections and the potential of CAR-T cells and bispecific antibodies. These insights will guide our development of a user-friendly, effective, and adaptable IBD treatment, while addressing patient concerns and enhancing the overall impact of our project.

Implementation
Through extensive secondary and primary research, we've developed a robust understanding of our project. For more details, see our entrepreneurship section. Here is a summary of our product:
Who are your proposed end users?
IBD patients
How do you envision others using your project?
We are developing IL-18BP capsules as a new biologic treatment for IBD. These capsules target the IL-18 cytokine, which drives inflammation. Patients can take this capsule for a cost-effective, non-invasive, and portable treatment option.
How would you implement your project in the real world?
To implement our project in the real world, we will introduce IL-18BP capsules as a convenient and affordable alternative to existing treatments like TNF and IL-6 inhibitors, which require costly injections. Priced at 475 RMB per box, our capsules provide a non-invasive, portable solution for IBD patients. Our market strategy involves a B2B2C approach, initially targeting hospitals with a 20% discount during the first two months. We will drive awareness through digital marketing on platforms like WeChat, Xiaohongshu, and Douyin, supported by celebrity endorsements and engagement with IBD communities. Additionally, we'll navigate legal and environmental considerations, focusing on supportive healthcare policies, sustainability, and IP protection as we expand. With startup costs covered and plans for a Suzhou factory post-clinical trials, we are poised to bring this cost-effective treatment to market.
For more information, please refer to this doc and our entrepreneurship page