Introduction to Project Safety
Project Overview and Safety Commitment

Our project is dedicated to utilizing synthetic biology technologies to construct efficient and safe microbial cell factories for the controllable biosynthesis of the cosmetic active ingredient Pro-Xylane. The project employs Komagataella pastoris as the primary expression host, achieving efficient conversion of xylan raw materials through the introduction of a dual-enzyme co-expression system comprising xylanase and Pro-Xylane synthase. We consistently adhere to the principle of "safety first," ensuring that all experimental activities are conducted under strict safety protocols. This guarantees that the entire process, from design and execution to subsequent applications, complies with the biosafety requirements of iGEM and relevant national and institutional standards.

We explicitly commit to not engaging in any activities prohibited by iGEM, including the use of Risk Group 3 or 4 microorganisms, the release of genetically modified organisms outside the laboratory, and human experimentation. All organisms, genetic parts, and experimental operations used fall within the iGEM White List and do not require additional approval. The entire project is conducted within controlled laboratory settings, with no release of organisms beyond containment measures.

Safety Commitment Laboratory Safety
Laboratory Safety Level and Operating Environment

All experiments in this project are conducted in a Biosafety Level 1 (BSL-1) laboratory, which complies with the safety standards of standard microbiology laboratories. We primarily use biological safety cabinets as the core equipment for handling biological materials, ensuring that genetic cloning, protein expression, and cell culture are performed under sterile conditions to effectively prevent aerosol contamination and cross-infection. Additionally, chemical fume hoods are equipped for handling flammable and corrosive chemicals used in experiments, ensuring the safety of operating personnel.

The laboratory strictly enforces an access control system. All personnel must undergo safety training and wear appropriate personal protective equipment (including lab coats, gloves, safety goggles, etc.). The laboratory has clearly designated zones, with biological and chemical wastes stored separately and subjected to high-pressure sterilization or neutralization treatment before disposal, ensuring no harm to the environment or personnel.

Laboratory Equipment Safety Equipment
Safety Assessment of Biological Materials and Genetic Parts

The organisms used in this project include E. coli (BL21(DE3), DH5α, Top10) and Komagataella pastoris (G418-resistant), all of which are internationally recognized safe host strains, non-pathogenic, and whose exogenous genes are stably maintained through chromosomal integration, eliminating the capacity for autonomous transmission. Although the plasmid vectors used (e.g., pET28a) carry antibiotic resistance genes (such as kanamycin resistance and G418 resistance), all bacterial cultures, media, and waste materials are inactivated through high-pressure sterilization before leaving the laboratory, effectively eliminating the potential risk of horizontal gene transfer.

Biological Materials

All synthesized DNA/RNA sequences are produced and screened by member companies of the International Gene Synthesis Consortium (IGSC), ensuring the absence of harmful genes or potentially hazardous sequences. The project does not involve the use of any raw samples derived from humans, animals, or the environment. All genetic parts are known, controllable synthetic biology components.

Chemical Usage and Risk Management

Various chemicals are used in the experimental process, including ethanol, isopropanol, phosphoric acid, hydrochloric acid, sulfuric acid, sodium hydroxide, sodium hypochlorite, etc., some of which are flammable or corrosive. We strictly adhere to the Safety Data Sheets (SDS) for handling and storage. All hazardous chemicals are stored in dedicated cabinets with clear safety labels.

All laboratory personnel have received training in chemical emergency response and are familiar with procedures for handling spills, leaks, and other unexpected situations. The laboratory is equipped with emergency eyewash stations, safety showers, and firefighting equipment, and regular safety drills are conducted to ensure rapid and effective risk control in the event of an accident.

Use of Artificial Intelligence Tools and Ethical Considerations

The project employs artificial intelligence tools for protein structure prediction and genetic design to optimize enzyme design and expression systems. We are fully aware of the potential risks of unconventional mutations in AI-assisted sequence design and have implemented multiple control measures, including experimental validation of prediction results, restrictions on the release of live bacteria, and strict adherence to laboratory access and operational protocols. These measures ensure that AI-assisted design does not introduce uncontrollable biosafety risks.

We are also committed to ongoing attention to the ethical and safety issues arising from the integration of synthetic biology and AI. We actively participate in relevant seminars organized by iGEM to enhance the team's awareness and understanding of "dual-use research" and its associated risks.

Risk Management System and Emergency Response Mechanism

We have established a multi-level, comprehensive risk management framework. A safety supervision team, composed of the project leader, laboratory safety officer, school safety supervisor, and the university's safety management office, regularly inspects and evaluates experimental activities. All team members have completed systematic safety training, covering biosafety operations, chemical management, first aid skills (such as CPR), and emergency evacuation procedures, and hold relevant certifications.

The laboratory has an incident reporting system in place, requiring the recording and timely reporting of any abnormal situations. We have also developed a "Project Emergency Response Manual," which covers various scenarios such as biological leaks, fires, and personal injuries. Regular drills are conducted to ensure that every member is equipped to handle emergencies.

On the regulatory front, we strictly comply with domestic and international standards, including the "Biosecurity Law of the People's Republic of China," the "Northwestern Polytechnical University Research Laboratory Safety Management Regulations," and the WHO "Laboratory Biosafety Manual," ensuring that the project advances within a legal and compliant framework.

References

  • Biosecurity Law of the People's Republic of China. Retrieved from http://www.npc.gov.cn/npc/c2/c30834/202010/t20201017_308282.html
  • Northwestern Polytechnical University Research Laboratory Safety Management Regulations. Retrieved from https://anguanban.nwpu.edu.cn/info/1022/1993.htm
  • World Health Organization. Laboratory Biosafety Manual. Retrieved from https://www.who.int/zh/publications/i/item/9789240011311
Conclusion

The design and execution of this project consistently prioritize safety. Through strict experimental protocols, systematic training mechanisms, comprehensive emergency preparedness, and a multi-level supervision system, we comprehensively manage various potential risks. We believe that only on a safe and reliable foundation can synthetic biology technology truly serve society and achieve its sustainable and responsible innovative value.