Creating a new biological system always comes with the possibility of unexpected outcomes. Biosafety is all about keeping things safe, using techniques, rules, and practices to prevent accidents or unintended exposure to harmful stuff. In our project, we didn't just think about safety once; we kept refining our safety measures at every step. We worked closely with our professors and experts from the industry to make sure we followed all the safety rules.

The lab that hosted us was the Vista lab (hyperlink with this) of the Department of Biological Sciences of BITS Pilani K K Birla Goa Campus. Our institute has an Institutional Biosafety Committee (IBSC), which is formed and governed by the rules and regulations of Review Committee on Genetic Manipulation (RCGM) serviced by the Department of Biotechnology, Ministry of Science and Technology, Government of India. Our PI heads the IBSC, and has gone over the proposal and run it by other IBSC members, all of whom have found the proposal to be within the rules. These experts are all trained in molecular biology and genetic engineering techniques, and have experience of more than a decade on biosafety procedures. They have overseen the procedures and methodology of the project and have expressed no reservations. Moreover, there have been training sessions for our team to make us well-versed in biosafety measures and precautions.

Taking note of the fact that drugs have side effects and can kill way more cells, we have made sure to use a drug (which acts on NSCLC) bound to a recombinant DNA part, which is basically a modified membrane receptor we’ve designed. The receptor has been optimized to bind to the drug and express the protein in high concentrations. Apart from that, we also have an antagonist called AM-6538, which is an antagonist to the cannabinoid receptor (chosen according to literature ¹), so we can release the drug only at the site at which T - cells travel to, i.e., the tumor sites. This helps ensure that there is no undue release of the drug at unspecified locations, i.e. non - cancerous cells.

AM-6538 has been theorized by us to be released via 2 mechanisms:

1. A biocompatible nanocarrier - based delivery system, which is highly specific to the tumor in question ², so the antagonist directly travels to the site of action.
2. The antagonist could possibly be placed in a biodegradable suture-based microsphere, and that can be used for targeted delivery³.

Both these mechanisms ensure that the antagonist doesn’t cause problems to other sources of the Cannabinoid Receptor 1 in the body.

Engaging with the community is a vital part of any iGEM project. It involves conversations with people, gathering their thoughts and opinions, organizing this feedback, and using it to shape our project. While our project doesn't involve working with human biological samples, it does entail significant interaction with stakeholders, especially in the context of a therapeutic-oriented project.
In line with iGEM's guidelines for human subjects research, we have diligently followed all national regulations regarding data collection. Our data collection process aligns with the Indian Council of Medical Research's National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017), with a strong emphasis on the principles of voluntariness and ensuring privacy and confidentiality outlined in sections 2.1 and 2.3, respectively.
It's important to note that all the data we collected was solely used for research and educational purposes. Additionally, we conducted interviews only with the verbal consent of the participants, and they had the option to remain anonymous if they wished.

We have strictly followed iGEM's Do Not Release safety policy. Our project is still at an experimental stage and no organism (genetically modified or otherwise) has been released or deployed outside a laboratory environment.