Overview

Synthetic biology has a great role in various fields, and because of its far-reaching impact, we must ensure the safety of all aspects of iGEM activities. In the process of experiment and product design, the iGEM team of Shanghai University of Science and Technology carefully considered the possible impact of our project in the present and future, and strictly followed the safety policy requirements of iGEM in every aspect.¹²³⁴⁵

Lab Safety

We do not carry out any activities that are banned by iGEM and all parts and organisms used are on a white list. We do not use animals or animal samples, and our laboratory members do not take Gmos out of the laboratory to ensure that our activities are in accordance with regulations and do not require additional permission. At the same time, due to the need of communication between human practice and people, we collected public opinions and opinions, and gave full explanations and obtained the permission of individuals and institutions before conducting research.

Our work at wetlab is carried out in the level 1 standard microbiological lab:

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Every wetlab member receives laboratory safety training from a professional prior to entering the laboratory, including learning the laboratory safety code to ensure that the laboratory personnel have adequate safety awareness. During the experiment, the experimentalists wear lab clothes and gloves to ensure the safety of the experimentalists. At the same time, during the experiment, we process biological materials in open bench to ensure that our experimental materials do not leak and pollute the environment and experimental personnel.

Product Safety

The purpose of our project is to build an E. coli system that includes sequences of V8 protease (or TEV protease), as well as a fluorescent reporting system based on super-fold cherry. When the V8 protease (or TEV protease) in E. coli is expressed and activated by thermolysin, it will cut the target sequence inserted in the fluorescent reporting system, resulting in a conformational change of the fluorescent protein, leading to fluorescence emission. When different foreign substances are added to the E. coli system (The molecules whose safety is approved by authorities, such as FDA.), the intensity of the fluorescence will change, from which we are able to find some sorts of inhibitors.

We used Escherichia coli in this experiment, and we used the strain DH5-alpha, BL21, but we didn’t use any other organisms. Although we have changed existing parts in the Registry, none of them are harmful. We order our DNA/RNA from IGSC member companies. We did all our experiments in DH5-alpha and BL21 (E.coli). We want to use TEV protein and V8 protein. We both bought them directly from the company and expressed them in E.coli. We found their sequences from protein database and synthesized their genes on plasmids from GenScript (IGSC member). We also engineered a new fluorescent reporter part, including two split parts of super-fold GFP/cherry and EGFP. This is also expressed in E.coli.

During the experiment, highly flammable chemicals and other hazardous chemicals were used, such as EDTA, Imidazole and Ni-NTA Agarose. However, we ensure that the operation is correct and the storage method is reasonable, and no experimental personnel are injured or the experimental environment is polluted. At the same time, we also used Large Language Models and Protein Structure Prediction Tools to assist our project.

Project Safety

We have evaluated the overall safety of the project and the possible risks are as follows. Our team use alcohol burners in the clean bench to prevent potential contamination. We also use EDTA, Ni-NTA and imidazole to purify proteins,which could cause skin and eye damage if a team member’s skin touches these chemicals in high concentration. Also, Ni-NTA agarose may start to burn if it is in contact with fire.Our team use alcohol burners in the clean bench to prevent potential pollution. A team member could accidentally burn himself when doing experiments in the clean bench. In order to prevent the occurrence of the above injuries, our experimental personnel have received complete laboratory safety training, everyone has memorized the experimental safety regulations, learned to identify differences between biosafety levels, and learned how to deal with various emergency situations, wear protective equipment to carry out experiments. The experimental materials were placed in order, and no one was injured during the whole process of the project.

We also analyzed the future risks of the project. What we might end up with is a small molecule that inhibits itching and will only be analyzed and studied in the lab. Our genetically modified organism will only be used in the laboratory. And the suitable molecules we find are already approved by FDA, it will mix with safe and common solvents such as vaseline to make a medical cosmetic product.The future development of our project would not require release beyond containment.

In our project, we’ve taken comprehensive risk management steps including project-specific safety training and consulting with biosafety experts to ensure our experimental protocols, particularly with genetically modified E. coli, are secure.

Through interviews with experts and stakeholders, we analyzed the possible negative effects of our project: it may be harmful to human health, the natural environment, specifically, the experimenter may be exposed to harmful reagents, and our strain may accidentally leak into the environment, causing contamination, but not spreading in the environment. Our genetically modified E.coli system is used as a testing platform in the laboratory, which will never be applied outside the lab. In the lab, there exists strict process to sterilize and contain the contamination of all kinds. This process is managed precisely by corresponding rules. To some extent, it is even more effective than a killer switch. Therefore, we consider it safe to not design a killer switch in our genetically modified E.coli. Besides, our E.coli is not optimized in metabolism. Thus, it is less likely to survive in the natural environment. And experts from Office of Environment, Health and Safety in our school will support us in managing risks in and outside the lab. Also, we can seek help from them.These measures collectively ensure our project adheres to strict safety standards and regulatory compliance.

Meanwhile, our synthetic biology project incorporates comprehensive safety measures to manage risks effectively. Here’s a simplified overview.We follow biosafety rules from Biosecurity Law of the People’s Republic of China 2024 and biosafety rules set by Office of Environment, Health and Safety in our school. Our team is trained in GMO handling, PPE usage, and emergency response to prevent accidents and handle biohazards. We work in a lab designed for GMOs, with clean bench and necessary PPE gears to ensure all genetic manipulations are securely conducted. We treat biological waste with autoclaving to inactivate GMOs before disposal, preventing environmental contamination. We use disposable labware, maintain thorough cleaning schedules, and restrict lab access to trained personnel to avoid cross-contamination and unsafe practices. Plus, we classify our waste to prevent contamination. These measures ensure our project is legally and ethically compliant, safeguarding our team members and the environment from GMO-related risks.

We are continuously monitoring and managing risks associated with our project by adhering strictly to iGEM’s safety and security rules and policies. Key risks we have identified include potential hazards related to handling chemicals. To mitigate these risks, we have implemented robust safety protocols, including strict personal protection and protocols, and comprehensive documentation of all procedures and materials.

In the future, we encourage ongoing updates to the iGEM safety guidelines, reflecting the latest developments in synthetic biology and biosecurity. We look forward to continuing to contribute to a culture of safety and responsibility within the iGEM community.