From Risk to Responsibility: Introduction to Safety and Security

Working to make a difference in this world also means paying attention to biosafety and biosecurity. Safety is not only about protecting ourselves as scientists but also about ensuring the well-being of the people who may one day use the products of our research, as well as the responsible use of our work by other scientists. Every researcher carries the responsibility to consider these aspects before even starting their experiments – to prevent accidents, safeguard public health, and reduce the risk of misuse.

Synthetic biology is a rapidly developing field, and with innovation comes responsibility. Ensuring that safety considerations are integrated from the very beginning is essential to protect both people and the environment and to maintain public trust in science.

Biosafety vs. Biosecurity
Biosafety Biosecurity
Focus Preventing accidents and unintentional risks Preventing misuse and intentional risks
Protection People, environment, and materials from unintended exposure Biological materials, data, and technologies from theft or abuse
Examples Lab coats, gloves, proper waste disposal, safe lab practices Restricted lab access, careful data handling, DNA sequence screening

Unfortunately, public opinion towards science is not always positive. Real risks are not only present inside the lab but also in how the public perceives scientific work. Negative attitudes toward genetic engineering and biotechnology can lead to petitions, resistance, or even rejection of important technologies such as GMOs. Addressing these concerns and engaging with society is therefore just as important as technical safety measures.

As a team, we do not see safety as a formality but as a mindset that guides our daily work. We aim to contribute not only to the safe progress of our own project, but also to the wider iGEM community and society. This is why we fully align with iGEM’s values: safety must remain at the heart of all research.

Safe, responsible, and justifiable science

should never be treated as an afterthought but rather as the foundation of everything we do.


Team Practices for Safe Research

Ensuring that our work is both safe and responsible requires more than just acknowledging the importance of biosafety and biosecurity – it demanded concrete action. From the very start of the project, we established clear safety practices through structured training, consistent laboratory routines, and careful risk assessment. These measures formed the foundation for all of our experimental work.

Safety Training

Before entering the lab, every team member studied iGEM’s Safety Rules and Policies and discussed together how we could ensure the safest possible working environment. We not only reflected on the rules but also shared ideas on how to support each other in day-to-day work.

Our training was guided by our supervisor and experienced doctoral researchers, who introduced us to:

In addition, we were given the contact details of our institutional biosafety officer as well as our designated first aiders, so that clear responsibilities were defined from the start.


Safe Laboratory Work

To maintain a safe environment, we consistently followed the principle of never working alone in the lab and always wearing the required protective equipment (lab coats, gloves, safety glasses). All experiments were performed under biosafety Level 1 (BSL-1) conditions, ensuring that our work environment matched the risk profile of our organisms.


Specific measures included:

Organism handling:

Chlamydomonas reinhardtii: chosen because it is non-pathogenic, lacks a cell wall in our strain, and cannot survive outside highly specific laboratory conditions.

E. coli: a standard White List organism widely used in teaching and research.

Human cell lines: used only for antibody functionality testing. These were kept in a separate laboratory building and handled by two specialized team members to minimize risks such as cross-contamination.

Chemical safety: Hazardous substances such as acrylamide, EtBr, or β-mercaptoethanol were handled with particular care, following institutional guidelines for personal protection and chemical storage.

Waste management: Both biological and chemical waste were carefully segregated, treated (e.g., autoclaving), and disposed of according to institutional and legal standards.

Laboratory infrastructure: We worked in facilities equipped with biosafety cabinets, autoclaves, eyewash stations, fire extinguishers, and first aid kits, ensuring rapid response in case of emergencies. We also considered physical risks in the laboratory, such as the use of high-voltage equipment during gel electrophoresis and high-pressure autoclaves. Team members were trained to use this equipment correctly, and appropriate safety devices were in place to minimize hazards.


Risk Management

Before the start of our experiments, we carried out a project-specific risk assessment. We considered not only laboratory safety but also the possibility of misuse outside the lab. While we acknowledge that it is impossible to fully control how scientific results might be applied in the future, we implemented safeguards such as:

In addition, we deliberately avoided the use of animal models for antibody testing. This decision reduced complexity, aligned with the 3R principle (Replacement, Reduction, Refinement) , and allowed us to focus on ethical and safe alternatives such as cell culture models. To build trust, we engaged in open dialogue with the public to address misconceptions and highlight the benefits of algae-based medicines. Transparent labeling and clear communication of both risks and advantages were essential to foster acceptance and responsible use. Through these measures, our team ensured that every aspect of our project – from planning to execution – was carried out in a safe, responsible, and ethically aware manner. This approach allowed us to focus on safe and responsible strategies such as cell culture models.


Building on Existing Knowledge: Biosafety and Biosecurity

While our team did not develop a new tool or framework in biosafety or biosecurity, we actively built upon established knowledge, guidelines, and best practices to ensure that our project was carried out in a safe and responsible way. For us, contributing to safety means showing how existing frameworks can be consistently applied within synthetic biology research and education. To guide our work, we relied on a wide range of established safety resources:

iGEM White List:

All organisms and genetic parts we used are explicitly listed on the iGEM White List, which identifies components considered safe for use in student projects. By relying only on these approved organisms – Chlamydomonas reinhardtii, E. coli, and human cell lines HT29, SW48, HCEC, CaCo-2, and HCT116 – we ensured that our work complied with iGEM’s community standards. This also meant that no additional Check-In procedures were required. The White List served as a practical framework for project design, helping us avoid unnecessary risks from the very beginning.

German and EU Biosafety Laws:

Our experiments were conducted under biosafety Level 1 (S1) conditions, in accordance with the German Genetic Engineering Act (Gentechnikgesetz, GenTG) and related EU directives. These regulations outline how genetically modified organisms must be handled, contained, and documented.

Key aspects included:

By following these legal frameworks, we ensured that our work was not only safe within iGEM standards but also fully compliant with national and European law.

Institutional Guidelines and Biosafety Officer:

At RPTU Kaiserslautern, all laboratory work is embedded in a strong institutional safety framework. Our team was supervised by our institutional biosafety officer, Prof. Gerhard Erkel, who provided guidance on risk evaluation and safety procedures. In addition, we followed the internal safety policies of our faculty, which cover topics such as:

This institutional support gave us a clear structure for safe daily work and defined points of contact in case of uncertainty.

International Standards (WHO and OECD):

Beyond local regulations, we considered international guidelines such as those developed by the World Health Organization (WHO) and the OECD for laboratory biosafety and biosecurity. These frameworks emphasize the importance of:

While we did not directly adopt new policies from these organizations, we ensured that our practices align with their broader principles, reinforcing the idea that our work is consistent with international safety culture.

3R Principle (Replacement, Reduction, Refinement):

Our project design reflects the 3R principle, which is widely recognized in scientific ethics. Instead of relying on animal models for antibody testing, we used human cell lines and algae-based expression systems (Chlamydomonas reinhardtii). In doing so, we:

This decision demonstrates that safety and ethics go hand in hand with scientific progress and that student teams can adopt the same high standards as professional research laboratories.

Our Perspective

Even without introducing a novel biosafety contribution, we believe that our careful implementation of existing safety principles can serve as an example for future iGEM teams. Responsible science is not only about developing new tools but also about respecting and consistently applying the frameworks that already exist. By demonstrating how these principles can be integrated into a student-led project, we hope to encourage others to approach their own work with the same mindset.


Case Studies and Public Perception

Risks in research are not only created by real dangers such as the misuse of samples and materials, but also by the way science is perceived by the public. The spread of misinformation, especially in the early stages of research, as well as large-scale media coverage of failed experiments and the uncertainty that arises when people lack scientific education or still hold outdated views, can make it difficult to convince the general population of progress. Often, the necessary knowledge to fully understand advances is simply missing.

An example of this was the broadcast of our project on German television. While our project itself was presented in a positive way, the introductory sentence to the research topic was phrased as follows (translated word-for-word from German): “Science is often not quite so simple, sometimes things seem rather abstract, but in the best case science helps us very concretely against diseases, against environmental problems, etc.” This reminded us once again that it is more important than ever to show society that science is something wonderful—provided it is conducted safely and responsibly.

To better understand public attitudes, we developed an online survey to reach as many people as possible and to collect opinions not only from students and young adults but also from the older generation. In addition, we included younger perspectives by asking high school students to complete written surveys during our school visits.

Our goal was to convince more people that science, when done correctly, is not inherently negative, and that research often brings great benefits, even if negative stories are heard more frequently.

This raises the question: What can be done in general to foster a more positive image of science in society? Education begins at an early age. Unfortunately, in German schools—although attendance is mandatory and therefore an ideal opportunity to spread knowledge—scientific literacy is often not given enough space. To address this, we reached out to teachers to organize our school visits as a first step. Together, we also discussed how this could be implemented more broadly in the future, for example by regularly inviting scientists to share their personal experiences and promote scientific knowledge. Additional suggestions collected through our surveys will be presented in our Human Practices.

Building trust in science requires both transparency and education. By listening to concerns, engaging in dialogue, and creating opportunities for early scientific education, we can help shape a society in which science is not seen as a threat, but as a driver of solutions to the world’s most pressing problems. Public perception is therefore a key factor in determining whether scientific advances can be successfully implemented in society. However, ensuring acceptance is only one part of the equation—equally important is guaranteeing that these advances are safe once they move from the laboratory into the real world. This raises the question of how projects like ours would be handled if scaled up for industrial and clinical use.


From Lab to Market: Safety in the Real World

Our project envisions the production of the monoclonal antibody Cetuximab using genetically engineered Chlamydomonas reinhardtii as a sustainable alternative to current mammalian cell culture systems. In the real world, this algae-based production system could be scaled up in bioreactors, and the purified antibody could be used in clinical applications for cancer therapy, particularly in the treatment of colorectal cancer. The final product would be highly purified and applied directly in the human body as part of standard medical treatment.

To evaluate the safety of such an approach, we considered not only our current laboratory practices but also the implications of future large-scale production, clinical use, and societal acceptance.


Applications and Risks in Real-World Use

If our system were translated into industrial and medical contexts, several potential risks would need to be addressed:


Mitigation Beyond the Laboratory

To ensure safety when applied in the real world, multiple layers of mitigation would be necessary:

  1. Industrial containment
    • Production facilities would be equipped with closed-system bioreactors, preventing environmental exposure.
    • Standard operating procedures would include sterilization, waste treatment, and validated containment checks.
  2. Downstream processing and purification
    • The antibody would undergo Good Manufacturing Practice (GMP)-compliant purification, removing algal proteins, DNA residues, and other impurities.
    • Extensive quality control tests (e.g., HPLC, mass spectrometry, endotoxin testing) would confirm product safety.
  3. Preclinical and clinical testing
    • Prior to approval, the antibody must pass through rigorous toxicology studies, preclinical testing in vitro, and clinical trials (Phase I–III) in humans.
    • These steps ensure that the therapy is not only effective but also safe across diverse patient populations.
  4. Ethical and communication measures
    • Open communication with the public would help address misconceptions and promote trust in algae-based medicines.
    • Clear labeling and transparent reporting of risks and benefits would help strengthen acceptance.
  5. Global access considerations
    • By reducing costs compared to mammalian systems, algae-based production could help make cancer therapy more accessible.
    • To realize this benefit, collaborations with healthcare systems and regulatory agencies would be essential to ensure fair pricing and global distribution.

Guidelines and Laws for Real-World Applications

If scaled to clinical use, our project would fall under multiple legal and regulatory frameworks:

Looking beyond our laboratory work, the real-world application of our project would demand rigorous containment, purification, testing, and regulatory oversight. While algae-based production offers clear advantages in cost, sustainability, and accessibility, its successful integration into medicine depends on strict adherence to clinical and industrial standards as well as transparent dialogue with society. By addressing these challenges, synthetic biology can deliver not only innovative solutions, but also safe, equitable, and trustworthy therapies for patients worldwide.


Safety as a Mindset

Safety in research is often thought of as a checklist of rules. For us, however, it was much more: a guiding principle that shaped both our laboratory work and the way we interacted with society. We treated safety not as a formality, but as an integral part of responsible science and as a value we want to pass on to others.

We approached every step of our work with the awareness that safety, responsibility, and ethics are inseparable from science. From our first training sessions to our project design choices, we continuously asked ourselves: How can we do this in the safest way possible? This culture of responsibility not only protected our team, but also ensured that our project developed on a solid ethical foundation.

Educational Outreach and Safety Awareness

Our commitment to safety also extended beyond our own laboratory work. Through workshops, surveys, talks with professionals, and school visits, we actively addressed questions of biosafety and biosecurity with students, teachers, and members of the public. In doing so, we aimed to spread awareness that synthetic biology can be both powerful and safe, provided that it is conducted responsibly. By including younger generations in these conversations, we hope to inspire a more balanced and positive public perception of biotechnology.

Supporting the iGEM Community

Even though we did not contribute a new safety resource, our project demonstrates that it is possible to conduct meaningful research by fully relying on and implementing the frameworks already available—such as the iGEM White List, national biosafety laws, and international standards. By documenting how we built upon these resources, we want to encourage future iGEM teams to see safety not only as a set of rules but as a guiding principle for their work.

Alignment with iGEM Values

iGEM emphasizes the importance of safe, responsible, and good science. Our project reflects these values by combining careful laboratory practice, transparent communication, and ethical decision-making. By integrating these elements, we ensured that safety was not an afterthought, but the foundation of our entire project.

Looking Forward

If our algae-based antibody production system were ever to reach real-world application, it would need to undergo rigorous containment, purification, and clinical testing. We are aware that innovation cannot succeed without responsibility, and that the acceptance of synthetic biology will depend on its ability to combine safety, ethics, and transparency. By reflecting on these aspects, we believe our project not only advances scientific ideas but also strengthens the culture of responsibility that is essential for the future of synthetic biology.

For us, safety was never just a box to tick—it was the foundation of our project and the mindset we will carry into our future as scientists.