In an effort to have a deeper understanding of their acceptance of synthetic biology products, we decided to design and hand out a questionnaire to parents of autistic children. We tried to reach parents from different social and economic backgrounds with the assistance of the online platform we built for parents with autistic children and from surrounding institutions and hospitals for people who have this condition. In this way, we were able to make our products better targeted. Besides sharing our questionnaires online, we also printed the QR code and brought them with us during our community service at Star of the Sea, a rehabilitation center for autistic children, and on our field trip to the Children's Hospital of Nanjing Medical University. We made sure that we had explained the aim of our questionnaire before sending them out and double-checked that the privacy of participants was well-protected. When designing the questionnaires, we ensured that our questionnaire would not direct people who were filling it and did not contain any biased questions. After analyzing the results with social scientific approaches, we realized that most of the parents were supportive of our work and showed their acceptance of synthetic biology products, which was genuinely reassuring. The content of the questionnaire, as well as our analysis, are available below.

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Community service at Star of the Sea

Star of the Sea is a non-profitable rehabilitation center for autistic children. During the summer break, we spent two weeks at the institution and had conversations with parents, educators, and social workers there to implement our project better. They further expressed their willingness to use synthetic biological products and showed their support for scientific advances.

Doctors and researchers

Researchers, developers, and doctors are important in the production chain of any scientific product that aims at diagnostic or therapeutic application. Therefore, we visited the Children's Hospital of Nanjing Medical University and interviewed doctors and professors for their advice on the feasibility of our project.

During our field trip to the Children's Hospital of Nanjing Medical University, we explained our project to the researchers and further learned how to obtain support from research centers and hospitals. We also visited the laboratory in the hospital, during which we discussed biosafety concerns with researchers there. Regarding our project design, they advised us to obtain broader technological as well as financial assistance. They also encouraged us to go further in the engineering aspect of the project to make for hospital applications.

Our interviews mainly focused on the scientific aspect of our design. However, procedures for introducing the project to hospitals were also discussed. Details are available in the Integrated Human Practice section.

In order to learn more about the current market of biotechnological products, we interviewed Xbiome, a leading AI-based microbiome drug development company in China. During the interview, the company directors shared their perceptions of the development and approval process of biotechnological products. They also told us that, compared to more developed countries in the world, related research in China has been rising slowly, and the Chinese research plan on synthetic biology was not formulated until 2011. We were both glad, however, that investment in SynBio research has increased over the years. By stating this, they advised us to collaborate with other organizations and carry out more educational activities for the general public. At the end of the interview, they encouraged us to keep working and offered valuable suggestions on validating the feasibility of commercializing scientific research. The content of the interview is presented on the page for Entrepreneurship.

On September 29th, we attended an online conference hosted by Mr. Wenjie Zhang, director of Shanghai Fuhong Hanlin Biotechnology Co., Ltd. During the lecture, Mr. Zhang introduced the innovativeness, risks, objectives, ideal size, and development speed of biotech and biopharma start-ups. We were able to have a deeper understanding of the current market in our country and developed a plan for further adjustment after his lecture.

This year, we established a close partnership with iGEM WHU-China since we are both on the therapeutic track. Besides supporting each other in terms of design and modeling, we also held an online meetup on the implementation of the projects. We first shared our business plans and offered suggestions for each other. After that, we discussed the possibilities of launching the product in the current market. Since laws on synthetic biological products remain to be further developed, we decided to focus more on the scientific aspect and go deeper into the validity, affordability, and safety of the projects. Meanwhile, biosafety concerns were also discussed, and related laws and regulations were studied as well to double-check that we were operating responsibly.

We had wanted to build a project that is safe and responsible for the world from the very beginning. As a result, we made it a routine to take turns explaining related laws and regulations within the team during our weekly meetings. This was an efficient way of educating every team member on the rules that we were supposed to follow. We also had open discussions on the possible aspects we could look at. Meanwhile, we would share our reflections after conducting experiments and check our actions based on biosafety regulations in our university. After writing an initial business plan, we presented the plan to our PI and team members that were not involved in the proposal of the first version and made revisions together.

In late August, we organized an online meetup on biosafety and related ethics withiGEM Nanjing_NFLS. In this online meeting, we talked about the regulations and rules about biosafety both in our country and our city of Nanjing. Additionally, we had a simulated debate on synthetic biological products. Determining whether products of synthetic biology are life or machines helped us have a better understanding of related ethics as we tried to launch our project. Since they are focusing more on manufacturing and industrial production, we shared our plans for future commercialization as well. It was interesting to learn about the differences between the two tracks.

As an important component of our commercialization plan, we have contacted stakeholders in different fields to ask for advice on biosafety. The suggestions that we compiled and our adjustments are well-documented in our business plans.

We considered it important to verify the functions of our engineered bacteria and drug delivery system before going further into launching the project. Therefore, we have designed and conducted experiments and applied mathematical modeling to demonstrate the functions. In terms of the experiments to verify the four systems, we followed the engineering cycle and conducted a series of experiments under the safety rules of our laboratory. Specifically, in the DESIGN part, we read hundreds of literature to accomplish the design of our four systems. In the BUILD part, we performed enzyme digestion/plasmid PCR/colony PCR and ran agarose gel to prove the successful construction or transformation of the plasmid. In addition, we use inducers of different concentrations to induce the protein expression and run SDS-PAGE gel to prove the successful expression of our target gene. In the TEST part, we performed different experiments for each system and successfully verified their function. In the LEARN part, we documented our successes, failures, and future plans, hoping them to be the cornerstone of our subsequent research, and the inspiration for future iGEM teams. You can learn more about our experimental demonstration from the wiki pages for Engineering success and Experiments.

Additionally, we applied mathematical modeling to help bridge the gap when we came across problems in the experiments, which promoted the feasibility of our project. Our efforts in modeling were divided into two large modules: the demonstration part and the analysis part. We first predicted the functions through gene pathway enrichment analysis and a lactic acid quantitative detection model. The analysis section, meanwhile, was divided into structural analysis and mathematical modeling. This included 3D molecular docking and models of bacterial growth as well as NAD+ concentration. Details of our work in modeling are discussed here.

Although we are on the therapeutic track this year, we still chose to focus more on the diagnostic approaches when it came to hardware design. This is because currently, it is not possible to launch our product since laws regarding synthetic biological products remain to be completed. In comparison, diagnostic products, such as testing strips, face fewer such problems. After verifying the functions of our biosensor for the assessment of mitochondrial dysfunction, we decided to design a lactic acid test kit as our hardware to detect mitochondrial dysfunction. We consulted experts and made an instruction for parents of autistic children, researchers, and doctors on the product as well. The exact design of our hardware is available in the Hardware section.

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We further developed two business plans for our project in late August. In addition, we discussed the possibility of expanding the project to a broader market and made plans for expansion and evaluation as well. More details are available on the Entrepreneurship page.

Launching our project into the real market requires a thorough evaluation of related risks. Therefore, we have discussed potential risks that we might come across in the future. We mainly identified three aspects: biosafety, ethics, delivery, and costs.