Human Practice plays a crucial role in pharmaceutical research and development! It refers to human-related practices aimed at ensuring that scientists and researchers fully consider ethical, social, and legal aspects when conducting drug development. Through engagement in Human Practice, scientists can gain a better understanding of the impact of drug development on human society and individuals, and take appropriate measures to ensure compliance with ethical principles and legal regulations. This helps ensure that the drugs developed are safe, effective, and in alignment with societal and ethical standards.

2023 BUCT iGEM

We completed the recruitment for the new year's iGEM team in February 2023. During this process, we discovered from a survey conducted by the International Society of Nephrology that there is a large global population of kidney disease patients, high treatment costs, and significant suffering associated with the disease. The global burden of kidney diseases is substantial, and we deeply empathize with this situation. We decided to use synthetic biology as a means to alleviate the current situation. In the months of March and April, we conducted 2-3 rounds of brainstorming sessions. Teams of 4-5 members each proposed many innovative topics. After in-depth discussions with our advisors, we decided to make kidney disease treatment the focus of this year's BUCT-iGEM competition project.

When our team initially embarked on the development of an adjunctive therapy for kidney disease, the initial idea was to create a biological peritoneal dialysis membrane as a treatment tool. However, after conducting literature research and consulting with advisors, the Principal Investigator (PI) pointed out what a successful synthetic biology solution should look like and highlighted the drawbacks of our existing project. The system was too complex and intricate, with strong interdisciplinary considerations, such as maintaining electrolyte balance, acid-base equilibrium, volume homeostasis, and engineering bacterial metabolism, among other factors.

We experienced our first setback, and subsequently, we went through a brainstorming process. Ultimately, we decided to retain the concept of utilizing microorganisms to break down urea and transform the idea of a biological peritoneal dialysis into intestinal probiotics.

Fecal microbiota transplantation (FMT) therapy utilizes beneficial gut microbiota species to modulate the gut microbiome, thereby improving the symptoms and health of kidney disease patients. This therapy holds promising treatment outcomes and a feasible implementation approach, which we believe can offer more effective adjunctive treatment for kidney disease patients. We will continue to work in this direction and look forward to providing better treatment options for patients.

We strive to explore health supplements, markets, and treatment methods in all possible areas to construct our human practice work. While enriching our investigative methods, we maintain a pure mindset. Below is our values and stakeholders section.


With the progress of project design, we have identified the project's priorities. Our key priorities or values for shaping our design considerations and stakeholder approaches for the NephroWiz product are as follows:

  • Safety: Ensure the safety of treatment plans and drug usage, minimizing patient risks and adverse reactions.
  • Efficacy: Strive for high-quality treatment outcomes, assisting patients in alleviating symptoms, delaying disease progression, and enhancing their quality of life.
  • Sustainability: Develop sustainable treatment solutions, reducing resource consumption, environmental impact, and ensuring long-term availability of an adequate supply of medications.
  • Feasibility: Ensure patients can access appropriate treatment, including economic affordability, social accessibility, and equitable allocation of medical resources.
  • Innovation: Seek new treatment methods and medications through innovative research and technology, providing better choices and opportunities for patients.
  • Prevention and Early Diagnosis: Focus on preventive measures and early diagnosis methods, aiming to reduce the incidence of chronic kidney disease and improve treatment effectiveness.
  • Patient-Centered: Prioritize patient needs and input, placing patient experiences and health outcomes at the core of the project, ensuring treatment plans align with their individual circumstances and expectations.
  • Educational: Provide patient education and support systems to help them understand the disease and manage their health. Simultaneously, offer healthcare professional training to enhance the quality of kidney disease treatment.

Stakeholder Approach

NephroWiz finds itself at a unique intersection of synthetic biology, medicine, healthcare products, and health strategy. We aim to leverage this intersection to gather a diverse range of perspectives and understand the expectations of each stakeholder regarding kidney disease medications within their specific goals and interests. We have adopted a stakeholder approach to reflect this diversity and, while maintaining an overarching direction and objective, have chosen to examine our stakeholder groups from a supply chain perspective. From considerations of raw materials to the potential implementation of the end product, we regard any substantively engaged participant as a potential stakeholder and engage with them, communicating based on their needs and preferences.

Kidney disease patients and primary healthcare providers

We are focused on addressing the issue of creatinine and urea not being properly purified and excreted by the kidneys. Our goal is to genetically engineer probiotics to settle in the gastrointestinal tract (enhancing the consumption of urea and creatinine, producing creatine through metabolism, and synthesizing polyglutamic acid using urea as an energy source). These probiotics will serve as auxiliary tools for the kidneys, purifying creatinine and urea in the gastrointestinal tract and excreting the produced polyglutamic acid through the colon. Ultimately, this aims to reduce high levels of creatinine and urea in the bloodstream. To understand the advantages and disadvantages of our project compared to traditional kidney treatment methods, we consulted from the Nephrology Department of the People's Liberation Army General Hospital (PLAGH 301 Hospital).
Dr. Shunlai Shang
Dr. Shunlai Shang, a postdoctoral fellow in the Nephrology Department at China-Japan Friendship Hospital, serves as the editor for two journals, Frontiers in Cell and Developmental Biology (JCR Q1) and Journal of Orthopedics and Spinal Disorders. Dr. Shang has hosted one postdoctoral research fund, received special funding for postdoctoral research, and obtained research grants from the International Association of Chinese Nephrologists (IACN). Additionally, he has taken on the role of the second principal investigator for a Beijing Natural Science Foundation project and participated in numerous national key research projects. Dr. Shang has authored or co-authored 14 SCI papers, with a notable work published in the Journal of Medical Virology (JCR Q1, SCI Impact Factor 12.7). He has also published 4 papers in Chinese core journals and holds one national invention patent.

At Dr. Shang's office, we received the answers we were looking for:

Method Advantages Disadvantages
Oral Adsorption Convenient, economical, safe Poor biocompatibility, low adsorbent targeting
Laxatives Promotes waste elimination, relieves constipation Supplementary therapy, limited applicability
Hemodialysis Mature technology, shorter treatment duration Multiple complications
Peritoneal Dialysis Suitable for home use, gentle process, good preservation of residual kidney function Multiple complications, low clearance efficiency
NephroWiz Safe, economical, environmentally friendly, aligns with traditional Chinese principles Supplementary treatment, not a cure, no animal testing

In addition, during the experimental process, we introduced gut probiotics as the host bacteria to eliminate waste products that the patients couldn't metabolize, such as creatinine and urea. However, while solving one problem, we introduced new questions about whether the use of gut probiotics might disrupt the balance between probiotics and the existing gut microbiota. We consulted with Dr. Shang, and he indicated that, based on some existing cases, it is less likely to result in an imbalance between probiotics and the gut microbiota. To avoid such an outcome, it is recommended to start with a small dosage and gradually increase it, allowing the body to build tolerance.

Furthermore, we inquired about the fluctuation levels of metabolic waste contents in the patients' bodies to optimize our dynamic components. Dr. Shang mentioned that the levels of creatinine and urea in patients' bodies generally remain consistently above normal values. However, in very rare cases, there may be multiple rapid fluctuations. Based on this information, we removed the original dynamic components, enhancing practicality and realism.

Dr. Shang expressed his approval of our project and provided some safety considerations. The team will need to conduct animal experiments, and potential side effects could include allergies, fever, nausea, vomiting, diarrhea, and the risk of life-threatening electrolyte imbalances. For patients with weakened immune systems or immunodeficiency, these bacterial strains could be extremely hazardous.

Additionally, Dr. Shang emphasized safety precautions. The team's animal experiments could lead to potential side effects, including allergies, fever, nausea, vomiting, diarrhea, and the possibility of causing life-threatening electrolyte imbalances. These bacterial strains may pose a significant risk to patients with weakened immune systems or immunodeficiency.

Dr. Shang also provided valuable advice for managing kidney disease or preventing it in advance:

  1. Avoid overly salty, oily, or acidic foods in your diet.
  2. Engage in regular exercise, especially aerobic activities. It is recommended to engage in vigorous exercise at least once a week.
  3. Maintain a positive mood and try to reduce stress.
  4. Keep a regular daily routine and avoid staying up too late.
  5. Quit smoking and reduce coffee consumption.

Through the discussions with Dr. Shunlai Shang, we have recognized the shortcomings in our project design and benefited greatly from his valuable insights. We will make further adjustments and improvements to enhance the feasibility and practicality of our project.

Pharmaceutical manufacturers and probiotics

Pharmaceutical manufacturers and probiotics companies have contributed to the creation of a sustainable and viable business model for us, with effective assumptions and strategies.

Selling a product means selling an idea and a process. Our human practice work is crucial in understanding the current state and needs of the kidney disease drug market. Understanding the treatment process and its application in hospitals helps us create a sustainable and viable business model with effective assumptions and strategies.

After gaining insight into the complexity and challenges of kidney disease treatment, the BUCT-iGEM team conducted in-depth market research to better understand the current state and demands in this field. By collaborating with medical experts, patients, and healthcare institutions, we collected a wealth of data and insights. This research helped us identify some key issues and potential opportunities in the field of kidney disease treatment.

Firstly, we found that kidney disease patients have an urgent need for more convenient, efficient, and innovative treatment methods. They hope to better manage their condition, reduce hospital visits, and minimize medication side effects. Secondly, healthcare institutions are also seeking more effective ways to manage kidney disease patients to reduce the burden and provide higher-quality care. Finally, doctors and researchers need more innovative tools and drugs to improve the effectiveness of kidney disease treatment.

We firmly believe that by combining science, technology, and healthcare, we can make significant breakthroughs in the field of kidney disease treatment. The launch of this product will support the principles of entrepreneurship and innovation, and we believe our kidney disease product will serve as an outstanding example. The development of this product is not just about treating kidney disease but also about inspiring and supporting innovation and entrepreneurship, combining medical technology with patient care.

Firstly, we will actively support the entrepreneurial ecosystem. We plan to collaborate with startups, medical technology entrepreneurs, and research teams to drive innovation in the field of kidney disease treatment. By providing data and resources, we will encourage entrepreneurs to develop new solutions to improve the quality of life for kidney disease patients.

Secondly, we visited pharmaceutical manufacturer "Zhenbao Island Pharmaceutical" and toured the probiotics production facility "Yakult Tianjin Factory" in an attempt to understand the drug manufacturing process, business models, and learn how their products make their way to the market and establish a strong presence in the market. We have begun to envision creating a sustainable and viable business model with effective assumptions and strategies.

Additionally, we will support education and training to nurture the next generation of medical entrepreneurs. We will collaborate with medical schools and research institutions to provide training and resources to help young medical and tech professionals enter the field of kidney disease treatment and ignite their innovative spirit.

Most importantly, we will support entrepreneurship in a sustainable manner. We recognize that innovation takes time and resources, so we will ensure that our products and support programs remain effective in the long term. We will actively partner with others to seek funding, resources, and collaboration opportunities to ensure ongoing development in the field of kidney disease treatment.

In summary, our kidney disease product is not just a treatment tool; it represents a concept that supports entrepreneurship. By combining science, technology, and innovation, we will provide better care for kidney disease patients while also offering a unique opportunity for medical technology entrepreneurs, driving continuous growth in the field of kidney disease treatment. We believe that through this innovative and collaborative approach, we can jointly create a healthier and more innovative future.

Sustainable energy strategies

Sustainable development goals and policymakers are assessing the role of kidney disease drugs in sustainable energy strategies.

As society continues to evolve, people are increasingly aware of the importance of sustainable development. From the values listed on the IGEM website, we can see that synthetic biology is more than just science or engineering. It represents a practice of constructing life and supporting that life within the framework of society and the environment. It is a practice closely related to humanity, with all our flaws and virtues. This approach is rooted in the values we hold dear, including integrity, sportsmanship, respect, honesty, celebration, cooperation, hard work, and excellence.

From this, it is evident that the official sustainable development goals of IGEM aim to promote practices that build and support life within the context of society and the environment. In this context, the sustainable development goals of IGEM projects are of paramount importance. Our project proposes a potential new method for treating chronic nephritis, involving the design of gastric-intestinal therapeutic bacteria that can clear creatinine and urea within the gastrointestinal tract and use these waste products to synthesize arginine and polyglutamic acid. Next, we will explain how this aligns with the practice of building and supporting life within the context of society and the environment.

From the perspective of building life, our project introduces a novel method for potentially treating chronic nephritis. This approach has the potential to reduce the treatment costs for patients, alleviate their suffering, and maintain kidney function in the long term. Our project utilizes gastric-intestinal therapeutic bacteria for treatment, which is safer, more effective, and longer-lasting compared to traditional treatment methods. Through our approach, we can gain a better understanding of the interaction between gastric-intestinal therapeutic bacteria and the human internal environment, providing greater possibilities for future medical research. Additionally, our research presents a new approach to the treatment of chronic nephritis, potentially offering patients more treatment options. Moreover, patients undergoing this form of treatment do not need frequent hospital visits, saving time and resources. Through this more convenient mode of treatment, we can effectively assist patients in regaining their health and improving their quality of life. In summary, our project offers a novel treatment approach that holds the promise of delivering better treatment outcomes and an improved quality of life for chronic nephritis patients, while also opening new avenues for future medical research.

From the perspective of supporting life within the context of society and the environment, our project holds a positive significance in reducing the waste of societal resources. Using gastric-intestinal therapeutic bacteria for treatment can reduce the generation of medical waste and lower the costs associated with medical waste disposal. Furthermore, long-term maintenance of kidney function can decrease the need for high-cost treatments such as kidney transplants or hemodialysis, thus alleviating the strain on healthcare resources and promoting their sustainable utilization. Therefore, our project not only provides better treatment methods and experiences for patients but also contributes to the sustainable development of society and the environment, thus improving the practice of building and supporting life within society and the environment and making a meaningful contribution to human health and well-being.

In conclusion, the awareness of sustainable development plays a crucial role in the design process of our project. Our project was carefully designed to align with the practice of building and supporting life within society and the environment, as emphasized by the official sustainable development goals of IGEM. Our novel treatment approach for chronic nephritis has the potential to bring significant benefits to patients, reduce resource wastage, and contribute to sustainable development, fostering the practice of building and supporting life in society and the environment.

The desires and concerns of ordinary citizens regarding safety and cost-effectiveness.

After 2000, biological research entered the genomic era, and the scale, speed, and complexity of DNA synthesis rapidly increased, making it possible to artificially design and synthesize entirely new functional genes. Synthetic biology entered a period of rapid development. Since then, synthetic biology, as a disruptive technology, has been accompanied by ethical controversies at every stage of its development [2-3].

In 1974, Jaenisch and Mintz introduced foreign genes into mouse embryos, creating the first transgenic mammals. The experiment's risks raised concerns within the scientific community. In response to this research, some scientists pointed out, "If the identification and synthesis of the minimal genome are simplified or equivalent to DNA, it is highly dangerous." Opponents argued that synthetic life could "open Pandora's box," and if synthetic organisms were to spread uncontrolled into the natural world, it might trigger genetic changes, leading to environmental disasters, and even be used to create bioweapons, causing endless suffering and catastrophes for humanity [3].

Currently, there is relevant probiotic research being used for disease treatment. For example, a research team [1] utilized the lactic acid bacterium Pediococcus pentosaceus to develop an effective bacterial drug delivery system for the treatment of colorectal cancer. When orally administered, engineered probiotics significantly reduced tumor volume and inhibited tumor growth in a mouse model compared to the control group, alleviating chemically induced microbiota imbalances. Inspired by the concept of using probiotics for adjunct therapy, our team is attempting to design a gastrointestinal probiotic, Neissour 1917, which functions as a "renal unit" within the gastrointestinal tract. This probiotic is capable of continuous removal of creatinine and urea. We hope that our probiotic can be developed into relevant drugs to assist in the treatment of kidney diseases. However, when faced with the introduction of such a microbiota-based drug formulation into the body, people's initial reaction is often panic and concern. To understand the public's perspective on the development of synthetic biology and related treatment concerns, we conducted visits to Beijing 101 Hospital, interviewed patients with kidney diseases, and organized numerous lectures on synthetic biology at schools and through online platforms. We also visited probiotic development factories to seek inspiration and assistance. Through organization and analysis, we can broadly categorize the public's concerns regarding synthetic biology into the following four categories.

  1. Safety Risks Synthetic biology involves modifying and designing organisms, including humans, animals, and plants. The public is concerned that this technology may pose unknown safety risks, such as the potential for the spread of new diseases or unpredictable impacts on ecosystems.
  2. Misuse Risks Gene editing technologies in synthetic biology can be used to manufacture biological weapons, and terrorist organizations may exploit these technologies to develop bioweapons, causing greater harm to society.
  3. Rights of Life Who has the right to design and reconstruct life? What are the criteria for design and reconstruction? Who should be responsible for the impact or potential harm caused by artificial organisms? If we excessively prioritize human-centered design that goes beyond ethics, it may pose significant risks to all of humanity.
  4. Cost-Effectiveness Taking CAR-T cell therapy as an example, the cost of a single treatment can be extremely high, depending on the severity of the condition and the treatment method. This is because the preparation and administration of CAR-T cell therapy require highly specialized technology and equipment, as well as strict quality control and monitoring. This is often unaffordable for most ordinary families, who typically opt for cheaper and more secure treatment options. Currently, most therapies utilizing synthetic biology are still in the laboratory stage, and the public's understanding of technological developments lags behind. People have doubts about their safety.

This helps us understand and design our NephroWiz kidney disease drug in all possible scenarios.

Ethics and Risk Management in Synthetic Biology

On September 1, 2023, two IGEM teams from Beijing University of Chemical Technology, the BUCT team and the BUCT-CHINA team, engaged in an intense debate on the ethics and risk management in synthetic biology. This debate aimed to facilitate in-depth thinking and discussions on the ethical issues and risk management challenges involved in the field of synthetic biology.

The debaters from the BUCT team actively presented their arguments on the ethical strategies of synthetic biology. They emphasized the immense potential of synthetic biology to provide new methods for improving human health and protecting the environment.

They pointed out that synthetic biology provides new avenues for creating new drugs, improving crops, and removing harmful pollutants, with the potential to advance fields such as medicine, agriculture, and environmental protection. We should seize this opportunity while also enhancing ethical education and implementing strict risk management measures to ensure the safe application of synthetic biology.

They warned that the development of synthetic biology could lead to unpredictable consequences and ethical dilemmas, and that we should use this technology with caution. They emphasized the need to establish strict regulations and legal frameworks to ensure the safety and societal acceptance of synthetic biology.

The debate was intense and heated, with both teams engaging in a rigorous exchange of arguments on the ethical and risk management issues of synthetic biology. Throughout the debate, team members demonstrated their profound academic knowledge and communication skills, providing the audience with an exciting academic event.

The judges highly praised the performances of both teams. They believed that the BUCT and BUCT-CHINA teams were able to clearly express their viewpoints during the debate and demonstrated in-depth research and thinking on ethical and risk management issues.

In summary, the debate on synthetic biology ethics and risk management between the BUCT team and the BUCT-CHINA team is of great significance. It not only promotes in-depth discussions on the ethical issues and risk management challenges in the field of synthetic biology but also provides a platform for academic exchange, knowledge sharing, and collaboration, contributing to the sustainable development of synthetic biology.

Education and Communication

Stakeholders and the education team are closely intertwined, with each step of education being linked to conveying the core ideas of our project. Our team simulates various stakeholders, further connecting education and communication with human practices. In doing so, we not only understand the concerns and thoughts of different roles but also deepen our understanding of synthetic biology.

When representing the ten different groups of roles in a debate, each group may present various arguments and demands. Here are some arguments that each group of roles may potentially raise:

  1. Patients and Their Families
    • Argument Our primary concern is the effectiveness of the treatment and the quality of life for patients. This medication should be safe, effective, and improve symptoms and the quality of life for patients.
    • Argument Pricing should be reasonable to ensure accessibility to a wide range of patients.
  2. Government Regulatory Agencies
    • Argument Our main focus is on public safety and health. This medication must go through rigorous approval and regulation to ensure compliance with drug laws and standards.
    • Argument Regulatory agencies should collaborate with pharmaceutical companies to ensure the timely provision of information regarding the effectiveness and safety of the medication.
  3. Pharmaceutical Companies and Research Teams
    • Argument We have invested significant time and resources in the research and development of this medication and should receive a reasonable return on investment to continue innovating and developing more treatment methods.
    • Argument This medication is the result of product innovation and is expected to improve patients' lives and bring commercial success to the company.
  4. Academic Community
    • Argument Independent research and clinical trial data are needed to validate the medication's effectiveness and safety.
    • Argument Research should undergo peer review in the scientific community to ensure data credibility and replicability.
  5. General Public
    • Argument The success of this medication will help reduce the public health burden, lower medical costs, and improve the quality of life for patients.
    • Argument Medication pricing should be reasonable to ensure that a broad population can access necessary treatment.

These arguments represent the concerns of different stakeholders, and the goal of the debate is to reconcile the needs and concerns of all parties to seek a balance that allows the medication to meet the needs of patients, medical standards, and commercial viability simultaneously.