Safety and Security

Overview

Safety and security are paramount in APOPTO-SENSE 2.0, our synthetic biology project for personalized cancer drug sensitivity testing. We adhered to iGEM's safety policies, ensuring all activities minimized risks to team members, the public, and the environment. Our system uses non-pathogenic mammalian cell lines (HEK293T and HL-60) and does not involve hazardous organisms, toxins, or gene drives. We completed the iGEM Safety Form and implemented protocols aligned with BSL-1/2 standards.

This page details our risk assessments, mitigation strategies, ethical considerations, and compliance measures, demonstrating responsible innovation in oncology biosensing.

Risk Assessment

We conducted a thorough risk assessment for all project components, identifying potential hazards and their likelihood/impact.

Hazard Risk Level Mitigation
Biological (e.g., cell cultures) Low Used non-pathogenic lines (BSL-1); sterile techniques; no GMOs released outside lab.
Chemical (e.g., raphasatin, transfection reagents) Medium Handled in fume hood with PPE (gloves, goggles); proper disposal as hazardous waste; MSDS reviewed.
Physical (e.g., lab equipment) Low Training on centrifuge, microscope use; electrical safety checks.
Security (e.g., dual-use potential) Low System designed for therapeutic use only; no weaponizable elements; ethical review for misuse risks.
Ethical (e.g., patient data in future applications) Medium Focused on commercial PDCs; future plans include IRB approval and data privacy (GDPR/HIPAA compliance).

Risks were evaluated using a matrix (likelihood x impact), with all high-risk items mitigated to low before proceeding.

Lab Safety Protocols

All experiments were conducted in a certified BSL-2 laboratory at WLSA Shanghai Academy, under supervision of our Primary Investigator.

  • Training: All team members completed biosafety training (e.g., handling mammalian cells, chemical safety) and signed lab agreements.
  • PPE and Procedures: Mandatory gloves, lab coats, and eye protection; no food/drink in lab; handwashing and decontamination protocols.
  • Waste Management: Biological waste autoclaved; chemical waste disposed via university hazardous materials program.
  • Incident Response: Emergency kits available; spill protocols followed; no incidents occurred.

We complied with local regulations (e.g., China's Biosafety Law) and iGEM rules, submitting the Safety Form early for review.

Project-Specific Safety Measures

APOPTO-SENSE 2.0 involves mammalian cell engineering but poses minimal risks:

  • Biological Containment: Stable transfections (PiggyBac) prevent unintended gene transfer; no viral vectors used.
  • Chemotherapeutic Agents: Raphasatin handled at low concentrations (<10 µM) in fume hoods; washed from cells before co-culture to avoid exposure.
  • Security Considerations: Dual-use analysis confirmed low risk (therapeutic focus); no sequences with biosecurity concerns (e.g., no toxins).
  • Environmental Impact: Low-waste design; reusable cell lines reduce plastic use; no release of GMOs.

Future clinical expansions will include kill switches for engineered cells to enhance biosafety.

Ethical Considerations

Integrated with Human Practices, we addressed ethics in personalized medicine:

  • No patient samples used (ethical pivot to PDCs based on stakeholder feedback).
  • Data privacy: All modeling anonymized; future apps will comply with regulations.
  • Equity: Designed for low-cost access in underserved regions.
  • Reviewed by bioethicists to ensure responsible innovation.

Conclusion

Through proactive safety measures, APOPTO-SENSE 2.0 exemplifies responsible synthetic biology. We prioritized risk mitigation to protect our team and community, ensuring the project's positive impact on oncology without compromising security.