Safety
Safety steps were implemented during the development of our biosensor, AptaTear. This was done by conducting risk assessments in and outside the laboratory, as well as analysing biosafety and biosecurity in Sweden. Safety is an important aspect to consider when implementing any synthetic biological product to our society, especially our biosensor, AptaTear. As synthetic biology is a developing field, this can result in an ambiguous trust towards technology derived from synthetic biology. Therefore, we have analyzed the risks, and safety and ethical issues of our project. The risk management can be categorized as either biosafety or biosecurity. Biosafety aims to handle containment of toxins and biological agents in a manner that would not endanger the public health and environment. Biosecurity aims to minimize the risk of loss, theft, misuse, misappropriation, or intentional unauthorized release of biological agents and toxins.
AptaTear was designed as a safe and easy diagnostic tool for users, namely for the healthcare profession. During the initial stages, potential risks were also discussed and considered; however, there is minimal risk when using aptamers. Furthermore, modeling of the aptamer was made to ensure that the biosensor would function as we expected, and to learn how to fully utilize the aptamers properties as an analytical/diagnostic tool.
If AptaTear were to be manufactured, we have considered all the safety precautions, and laws and regulations for the biosensor. As our kit would be manufactured and implemented in Sweden, our kit adheres to the Swedish Medical Product Agent (Läkemedelsverket). In the case to further expand an eventual production, further research in law and regulations of the intended countries would be required.
There are certain concerns regarding the use of our detection kit, AptaTear. This would be the potential misuse of the product, and illegal distribution of the kit. Taking this into consideration, our team would take preventative methods to ensure that our product will not be misused/distributed, by patenting our product. Furthermore, the kit would be handled by professional health care employees, which would further ensure that misuse of the product does not occur. In addition to this, our kit is simple to use and requires no PCR machines. Instead, we opted for a heating block with constant temperature.
Transporting the product would be low cost and environmentally friendly, as there would be no additional requirement for refrigeration, or dry ice, as it can be transported at room temperature. In addition to this, we would follow the guidelines set by Folkhälsomyndigheten (Public Health Agency of Sweden).
The recommended storage temperature of AptaTear would be between 4°C for the short term, whereas, long term requires the mix to be kept in the freezer at -20°C.
As aptamers are neither toxic nor immunogenic, there is no additional concern for disposal.
All members were required to attend mandatory lab safety instructions and lab tours given to us by our PI’s, Per Hammarström and Lars-Göran Mårtensson, before starting the project.
Our iGEM lab is located in the Institution of physics, chemistry and biology (IFM) department in the B-House on campus Valla at Linköping university. The laboratory contains all the necessary equipment required for the manufacturing of our kit. All laboratories at Linköping University follow the international laboratory biorisk management agreement; CWA 15793. In addition to this, before each laboratory session, a web tool named KLARA that was developed by the Public Health Agency of Sweden was used.
To further ensure that all members were familiar with the safety regulation during an emergency, various emergency drills were arranged and performed. These included:
General Campus Safety (fire drills, emergency exits, emergency contacts, etc..).
Laboratory Safety (chemicals, lab attire, disposal, etc..).
Biological Safety (disposal of bio-organism, safety precautions, etc..).
At all morning meetings, the members that would work in wet-lab that day would be required to undergo thorough discussion about the lab precautions, as well as a minor test to ensure that members understood.
iGEM highly values safety, therefore, iGEM headquarters have been arranging workshops to address matters regarding biosecurity. The main purpose is to raise awareness for all teams involved and discuss the possible preventative methods. An issue that could arise from our kit is the misuse or illegal distribution of our kit. However, AptaTear is harmless and does not contain any special chemical that can be used in a misguided way. Furthermore, AptaTear will be distributed to health care centers and the kit would be handled by professionals. Although, a method to prevent the illegal distribution of our product would be to obtain a patent. This would prevent other competitors from selling and the illegal distribution of our kit.
E. coli is categorized as biosafety level 1 (BSL-1), meaning that there is no immediate danger, but there are still regulations that must be followed. For example; lab coats and gloves must be worn when handling this bacteria, in addition to other safety guidelines that have been set by UC San Diego Biosafety and World Health Organization (WHO). Furthermore, the bacteria must be sterilized before disposal for the safety of the environment.
A commonly used non-radioactive marker that is used to stain the DNA, and is used for identification and visualization for either electrophoresi,s or gel-based methods of nucleic acid separation. Ethidium Bromide (EtBr) is a potent mutagen (causing genetic damage) and can be absorbed through skin contact. When exposed to EtBr in powdered form, it can cause irritation to the upper respiratory tract, eyes, and skin. However, EtBr was handled in dilute solutions in a specific fume hood designated for staining of DNA, and extra precautionary steps were taken, such as wearing the thick gloves that are often used to handle EtBr.
Liquid Nitrogen contains some hazardous characteristics, and must therefore be handled with care, as it is colorless, odorless and a tasteless fluid. It has a boiling point of -196 degrees celsius, and can result in frostbite when being handled. Furthermore, the gas displaces oxygen in the air and can cause oxygen deficiency, resulting in symptoms such as dizziness, unconsciousness, and even death. Therefore, handling of liquid nitrogen was done by the PI:s ,and members were well-informed of the risk before attending the laboratory, by reading the risk assessment provided by the university in regards to handling liquid nitrogen.
In consideration to the pandemic, safety measurements were taken to prevent the further spread. Face masks were worn when working in the lab, and in the case that an individual would show symptoms, rapid antigen tests were taken and self-isolation for two days were required before working on campus again.