Outlining the safety and security measures embedded throughout our project—from lab protocols and risk assessments to ethical safeguards and regulatory compliance.
Maintaining adherence to these guidelines was non-negotiable. Our commitment to safety isn’t just on paper; it’s the very foundation on which we build, test, and innovate.
Overview
Genetically engineered organisms can be just as dangerous as they are useful to us humans. It is essential for us to protect ourselves, the environment, and the equipment from any effects of our project.
With safety always at the forefront, our team thoroughly analyzed our project, adhered to Good Microbiological Practices (GMP), and followed essential safety procedures and systems at all times.
Biological Safety & Organisms
Our project primarily relies on Saccharomyces cerevisiae, a GRAS (Generally Recognized As Safe) organism. This yeast is on the official white list and is widely used in both laboratory and industrial research because of its reliability, safety, and long history of human use.Our project primarily relies on Saccharomyces cerevisiae, a GRAS (Generally Recognized As Safe) organism. This yeast is on the official white list and is widely used in both laboratory and industrial research because of its reliability, safety, and long history of human use.
In addition, we work with Proteus vulgaris for its high efficiency in melanin synthesis. While P. vulgaris is an opportunistic pathogen, we treat it with the same level of caution as any potentially hazardous organism. To ensure the safe handling of both organisms, we adhered to a comprehensive set of biosafety practices throughout the project.
Our safety framework included:
Controlled Handling: All cultures of both S. cerevisiae and P. vulgaris were managed exclusively inside biosafety cabinets to prevent any chance of exposure or environmental release.
Protective Measures: Personal Protective Equipment (PPE), including gloves, lab coats, and protective eyewear, was worn at all times when working with the organisms.
Standardized Protocols: Every piece of equipment was operated according to established Standard Operating Procedures (SOPs), ensuring that experiments were performed consistently and safely.
Emergency Preparedness: fire extinguishers placed at accessible points in the lab, along with clearly posted emergency contact numbers
Culture Security: Extra precautions were taken during culture preparation, maintenance, and disposal to reduce the risk of accidental release or cross-contamination.
Sterilization Practices: UV sterilization was employed as an added safeguard for work surfaces and equipment, further minimizing risks.
By applying these procedures to both organisms, we built multiple layers of protection into our workflow. This not only ensured the safety of the research team and the laboratory environment but also reinforced the reliability and reproducibility of our experiments.
Chemical & Physical Safety
By applying these procedures to both organisms, we built multiple layers of protection into our workflow. This not only ensured the safety of the research team and the laboratory environment but also reinforced the reliability and reproducibility of our experiments.
Hazardous chemicals, such as ethidium bromide, were handled with the utmost caution to minimize exposure and ensure the researcher's safety.
All consumables and instruments, such as pipette tips, glassware, and culture vessels, were sterilized through autoclaving and/or UV exposure, depending on their suitability.
Our laboratory safety infrastructure was comprehensive and included:
Material Safety Data Sheets (MSDS): readily available for all chemicals to guide safe handling and response in case of accidents.
Standard Operating Procedures (SOPs): established and followed for all protocols to ensure consistency and safety in experiments.
Emergency Preparedness: fire extinguishers placed at accessible points in the lab, along with clearly posted emergency contact numbers.
Project Design & Environmental Safety
We avoid introducing any unnecessary hazardous elements in our design. We selected designs and materials that proactively minimise the potential for biological risks and contamination.
Material Safety Data Sheets (MSDS): readily available for all chemicals to guide safe handling and response in case of accidents.
Safety-Oriented Design: Every procedure was developed with the highest regard for laboratory safety and environmental protection, including robust containment and thorough decontamination practices.
Biomass Handling: The biomass obtained from yeast cultures was lysed, and protein was extracted for formulation purposes. Since the laboratory strain used was not suitable for food-grade applications, nor was food testing permissible, all extracted material was clearly labeled and stored safely in powdered form at –80 °C within the laboratory.
To enhance the sterility and reliability of our bioprocesses, we employed specialized materials:
Melanin–Polyvinyl Alcohol (PVA) Sheets: These were used to coat the bioreactor, forming a protective biological barrier that maintains sterile conditions essential for sensitive processes. [1]
PVA as a Base Material: PVA is non-toxic, chemically resistant, and biocompatible. When combined with melanin, it creates a durable film that disrupts bacterial colonization and prevents contamination. [2]
Added Benefits of Melanin: Beyond its barrier function, melanin provides UV protection, shielding the bioreactor’s contents from UV-induced damage and oxidative stress, thereby improving process stability and longevity.
During the evaluation of the PVA–melanin sheet’s efficiency, we opted to use standard baker’s yeast instead of our genetically modified lab strains for space testing using a balloon facility in collaboration with TIFR ( Tata Institute of Fundamental Research, Mumbai) . This decision was made to prioritize safety and minimize potential risks associated with sending genetically modified organisms into a space environment. Baker’s yeast is well-characterized, non-pathogenic, and widely used in both research and industrial applications, making it an ideal model organism for assessing the protective properties of the PVA–melanin coating under space conditions. By using a safe and robust organism, we were able to reliably test the sheet’s performance in terms of sterility maintenance, UV protection, and overall stability without introducing unnecessary biosafety concerns.
Space Safety, Security & Dual Use Nature :
Unlike on Earth, space presents unique challenges where even minor changes in conditions can pose significant hazards. Our project carefully considers these risks and adheres to rigorous safety requirements, ensuring optimal performance while minimizing the likelihood of errors. To account for the effects of microgravity and space radiation, our bioreactor is specifically coated with melanin-PVA sheets, creating a radiation-resistant environment that allows biological processes to proceed smoothly. To further prevent leakages, we employ epoxy sealants, which offer excellent chemical and thermal resistance and effectively block moisture ingress.
Synthetic biology is often described as a double-edged sword: while it has the potential to revolutionize sectors such as food, pharmaceuticals, agriculture, and therapeutics, it can also be misused in ways that pose ethical or safety concerns, commonly referred to as “dual uses.” In our project, the use of DSUP plays a critical role by reducing damage caused by radiation and oxidative stress, making our organisms highly resistant to both radiation and other forms of cellular harm. This made it essential for us to carefully consider potential worst-case scenarios.
Through the Dual Use Research of Concern (DURC) workshop organized by iGEM ambassadors at the All India iGEM Meet, we gained insights into how poor management of a project could lead to severe misuses, including militarization. Guided by our PI, Dr. Shamlan Reshamwala, we recognized the importance of seeking advice from professionals with relevant expertise. Mr. Alonso Flores, iGEM’s Safety & Security Officer, advised us to investigate biological waste disposal methods aboard the ISS and to evaluate containment risks, particularly regarding accidental release or ingestion of GMOs in space. He emphasized the importance of understanding yeast elimination techniques and identifying chemical vulnerabilities to ensure biosafety.
We also consulted Jezabel Grigena, a leading biosafety expert, who recommended conducting toxicity testing and assessing the broader implications of radiation-induced mutations by reviewing relevant research. She further suggested exploring industry practices, such as those of Yuri Gravity, and examining previous iGEM projects like the 2016 Minnesota team, which had considered gene drives. After reviewing their approach and discussing it with our PI, we confirmed that our project design does not involve the use of gene drives. Subsequently, we engaged with Mr. Christopher Isaac, Director of Responsibility at iGEM, who facilitated a review of our abstract with the Safety & Security Team and recommended the implementation of a comprehensive Risk Assessment Analysis to ensure the safe progression of our work.
These discussions and consultations provided invaluable insights into the security and safety protocols required for conducting our project in space. They also helped us understand potential dual-use risks and develop strategies to prevent misuse, reinforcing our commitment to responsible and safe synthetic biology research.
Future Innovations & Safety Concerns
While we are still in the process of fully understanding all the potential risks and hazards associated with our project, we are actively working to identify and eliminate any possible dual-use scenarios. A key aspect of this involves understanding how space conditions may induce harmful variations in our product. It is equally important to establish robust methods for monitoring health and safety, including detecting contamination risks and determining strategies to manage them, particularly in resource-limited environments like the ISS, where immediate infrastructure and support are not available.
Although our project does not involve releasing genetically modified organisms into the ecosystem, we remain prepared for unexpected events, such as accidental leakages. To mitigate such risks, all cells are thoroughly sterilized using standard sterilizing agents like ethanol, hydrogen peroxide, peracetic acid, or physical methods such as UV or gamma radiation. The specific dose of radiation required to completely inactivate the strain is determined using kill curves, ensuring that sterilization is both effective and reliable, thereby preventing any unintended growth or release.
Conclusions
Through these workshops, consultations, and careful planning, our team gained invaluable insights into both the security and safety measures required for working in space. We now have a clear understanding of how to conduct our project responsibly, prevent dual-use risks, and maintain biosafety while advancing synthetic biology research beyond Earth.
[1] Liu, H., Yang, Y., Liu, Y., Pan, J., Wang, J., Man, F., Zhang, W., & Liu, G. (2020). Melanin-Like Nanomaterials for Advanced Biomedical Applications: A Versatile Platform with Extraordinary Promise.Advanced science (Weinheim, Baden-Wurttemberg, Germany), 7(7),1903129 Link
[2] Properties and antimicrobial activity of polyvinyl alcohol-modified bacterial nanocellulose packaging films incorporated with silver nanoparticles Link
[3] Momtaz, F., Momtaz, E., Mehrgardi, M.A. et al. Enhanced antibacterial properties of polyvinyl alcohol/starch/chitosan films with NiO–CuO nanoparticles for food packaging.Sci Rep 14, 7356 (2024) Link
[4] Millett, P., Alexanian, T., Palmer, M. J., Evans, S. W., Kuiken, T., & Oye, K. (2022). iGEM and Gene Drives: A Case Study for Governance.Health Security,20(1), 26-34 Link
[5] National Academies of Sciences, Engineering, and Medicine et al., 2018, 5 Link
[6] Are the EU biosecurity legislative frameworks sufficiently effective to prevent biological invasions in the Natura 2000 network? – A case study in Mediterranean Europe:- Link
[7] iGEM Safety Instructions and Requirements Link