Safety and Security

Overview

Within the core values of the iGEM competition, safety has always been regarded as one of the most important principles. From project conception and experimental execution to potential applications, iGEM requires teams to consider safety and ethics at every stage, ensuring that innovation is grounded in control, responsibility, and accountability.Safety is not only the baseline of synthetic biology research, but also the foundation for its sustainable development.

With the rise of AI-driven de novo protein design, biosafety considerations have become even more crucial. Since these proteins are computationally generated sequences that do not exist in nature, we integrated biosafety evaluation throughout the entire project—from conception to experimentation.We strictly adhered to iGEM’s Safety and Security Policy, the Whitelist Guidance, and followed the precautionary principle emphasized by the Safety Committee.

Our ShanghaiTech-China Team firmly upholds the belief that “Safety is the foundation of innovation.” At every step of design and experimentation, our team considered risk prevention and bioethics to ensure that our project is safe for researchers, the public and the environment.

Communication

Throughout the project, we maintained continuous communication with the EHS Office of ShanghaiTech University, receiving guidance on laboratory safety management and emergency response procedures. We also regularly reported our experimental designs and risk assessment plans to mentors to ensure full compliance with university biosafety regulations.

In addition, our team communicated directly with the iGEM Safety Committee via email, providing detailed descriptions of our de novo protein design experiments and biosafety strategies. We received formal approval and constructive feedback.

Biosafety and Whitelist Compliance for de novo Protein Design

For all sequences of de novo design proteins generated in this project, we established a comprehensive computational biosafety screening pipeline to ensure full compliance with iGEM’s White-List Guidance and Safety Committee recommendations.

Before synthesis, every generated sequence was cross-checked against the NCBI and UniProt pathogen databases using BLAST. Sequences showing significant homology with toxins, virulence factors, immune modulators, transferases, or pathogen-related proteins were automatically excluded.

Our de novo design proteins were strictly limited to recognizing GZMK, with no involvement in essential biological pathways and no predicted toxicological or immunological effects on hosts.

Through this systematic screening process, we confirmed that all designed proteins did not fall into any of the risk categories listed in the official Safety Committee correspondence, such as toxins, immune regulators, or non-proteinaceous toxins. Throughout the entire design phase, we followed the precautionary principle, treating all new sequences as potentially risky and maintaining research within a safe and controlled scope.

Safety Training and Supervision

Before entering the experimental phase, all team members completed biosafety and chemical safety training courses provided by ShanghaiTech University and passed the safety examination administered by the EHS Office. The training covered microbial and cell culture procedures, proper PPE usage, waste management, and emergency response protocols.

Our team also developed internal safety guidelines, which every member signed and agreed to follow. New members were required to conduct early experiments under the direct supervision of senior students or instructors to ensure compliance with BSL-2 standards and prevent operational errors or contamination.

Throughout the experimental period, the team strictly followed Standard Operating Procedures (SOPs), controlled access to laboratory areas, and ensured traceability of all samples to maintain safety and data integrity.

Laboratory Safety

All experiments were conducted in Biosafety Level 2 (BSL-2) laboratories at ShanghaiTech University, under the supervision of qualified instructors and the university’s Environment Health and Safety (EHS) Office.

We used Escherichia coli (E. coli) and HEK293 cell lines during our project. The E. coli strains used are Risk Group 1 microorganisms, while the HEK293 cells are Risk Group 2 cell lines. Therefore, all experiments were carried out within appropriate BSL-2 laboratory conditions.

Our laboratory follows a dual management system for biosafety and chemical safety. Before entering the lab, all personnel are required to wear proper Personal Protective Equipment (PPE) including lab coats, gloves, and protective goggles. The cell culture and bacterial operation areas are strictly separated to avoid cross-contamination. All workspaces are kept clean and organized, and all biological waste and chemical liquid waste are clearly labeled, classified, and autoclaved before disposal.

EHS regularly inspects biosafety cabinets, ventilation systems, and emergency facilities to ensure proper functionality of eyewash stations, showers, and fire extinguishers. Operations involving hazardous chemicals are performed inside fume hoods and follow the ShanghaiTech University Chemical Safety Operating Manual.

Throughout the experimental period, no safety accidents or contamination events occurred.

Project Safety and Risk Management

Our safety management system covers chemical, biological, and informational risks.

At the experimental level, all operations involving hazardous chemicals were performed in controlled environments, and proper PPE and handling procedures were enforced to minimize potential chemical hazards.

Regarding biological risk, all strains and cell lines were handled under BSL-2 conditions. Waste materials were autoclaved before disposal, and the entire process was routinely reviewed by EHS personnel.

For the potential risks associated with de novo protein design, we strictly followed the precautionary principle, treating all newly designed proteins as materials that may possess unknown biological activity. All experimental operations were restricted to in vitro systems only, with no animal or human testing involved.

The project did not use any infectious materials or collect patient samples. All experiments were conducted using purified proteins and established cell lines, eliminating risks of biohazard transmission or ethical violations. No safety incidents occurred during the entire project.

Future Application Safety

In potential future applications, the designed GZMK-binding proteins are intended to serve as in vitro diagnostic reagents for detecting biomarkers associated with chronic rhinosinusitis. Their use will be strictly limited to biosafety-certified laboratory models, and they will not be released into the natural environment.

By design, we deliberately avoided targeting essential proteins, excluded domains that could cause Horizontal Gene Transfer (HGT), and ensured that all engineered organisms are incapable of survival or propagation in natural environments. This approach allows us to pursue scientific innovation while maintaining rigorous control over potential biosafety risks.