Human Practice
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This year, our SHSBNU_China team carried forward the commitment to Human Practice and Integrated Human Practice, emphasizing how we impact the world and how the world, in turn, influences our work. Our approach bridged the gap between synthetic biology research and its real-world implications, fostering interactions with a broad range of individuals and communities.
Throughout our project, we conducted extensive engagements, including 8 in-depth interviews, and multiple community interactions through both in-person and online platforms. We utilized questionnaires and held educational campaigns to gather insights, feedback, and suggestions, which played a crucial role in shaping our research directions. These engagements provided us with a broader perspective on the social, ethical, and practical aspects of our synthetic biology project, especially in its application to mental health and anxiety relief.
Our Human Practices journey is structured into four key stages:
Project Applicability – where we explored societal needs and gathered input from various stakeholders
Feasibility Validation – focusing on verifying the feasibility of our synthetic biology solutions in addressing anxiety
Design Optimization – which involved refining our designs based on real-world feedback
Project Expansion – where we worked on amplifying our project’s impact through community outreach, educational activities, and collaboration with experts
By integrating external insights and real-world feedback into our scientific process, we ensured that our project was not only scientifically robust but also socially relevant and impactful.
In the process of brainstorming, we realized that anxiety seems to be a problem faced by many people, but most people know little about how to alleviate or cope with it, and they are even less informed about anxiety disorders. To verify our hypothesis, we created a survey questionnaire, which was spread it through WeChat online. The target audience through this survey will be mainly high school students around our age, plus a small portion of adults in their 40 and 50s, which are parents of the peer students. We collected a total of 329 valid responses after three weeks of survey. Through the survey questionnaire, we learned that 81.48％ of the participants have experienced symptoms of anxiety or insomnia, and 18.52％of people have not experienced such symptoms. From this, it can be concluded that anxiety and other issues are problems that most people will face.
Additionally, the survey results show that only 11.93% of people have taken corresponding medications or health products for treatment or relief, while the majority (88.07%) have not used any medications or health products for treatment or alleviation.
Furthermore, the results of the multiple-choice questions in the survey revealed people's preferences for different product forms. The majority chose candy and capsules, accounting for 73.47% and 63.27% respectively. A portion of respondents also selected auxiliary devices (humidifiers, oral sprays, inhalable sprays, etc.), pre-packaged beverages, instant mixture, and energy bars. A respondent could choose as many options as needed, hence the total percentage in the pie chart exceeds 100%. This survey has provided inspiration for our product form.
The survey has revealed that anxiety is a widespread issue affecting the vast majority of people, yet many are unaware of effective ways to alleviate it, which further highlights the necessity of developing a product that is both effective and easily accepted. Therefore, we hope to leverage synthetic biology to facilitate the relief of anxiety.
Interview content:
To understand the current situation, we interviewed Ms. Xinyuan Zhou, a registered psychologist with the Chinese Psychological Society, who has over 18 years of training and professional experience, with more than 4500 hours of counseling time. She has accumulated rich counseling experience in the field of children and adolescent mental health. We first introduced the project background and experimental details to Ms. Zhou, and then conducted the interview around two main directions: the universal phenomenon of mental health problems and their impact on the lives of adolescents, as well as specific suggestions and directions for improvement for our project.
Through the interview with Ms. Zhou, we learned that most adolescents will face anxiety, but among the adolescent groups who come for consultation, the proportion of those with depression is higher, while the number of patients with anxiety disorders is relatively lower. Ms. Zhou pointed out that depression often comes with obvious physical symptoms, such as vomiting, insomnia, abdominal pain, etc., which seriously affect study and life, and thus are more likely to be noticed and taken seriously. Anxiety disorders, on the other hand, usually manifest only as emotional anxiety and are easy to be overlooked, leading to patients seeking medical attention when the condition has often developed to a more serious degree, requiring a longer treatment course for adjustment. Theanine products can effectively prevent anxiety and do not have the side effects of drugs, making them a good choice for adolescents to cope with anxiety.
Anxiety is usually a gradual accumulation, which is related to our support systems. Support systems include both internal and external aspects. When anxiety cannot be resolved and turns into helplessness and despair, and the internal system is unable to support and is unwilling to seek help externally, it can become uncontrollable, leading to an escalation and diffusion of anxiety, and even generalizing to anxiety about everything in life. Typically, adolescents who come for counseling have reached this severe level. She suggests intervening with theanine products as early as possible when stress first appears, to prevent emotions from deteriorating like a snowball, because once a sense of helplessness is produced, it is psychologically difficult for adolescents to adjust on their own. In addition, adolescents usually do not seek help proactively, and psychological medications are often symptomatic rather than curative and have strong side effects.
Summary: through this interview, we have learned that anxiety disorders are often detected in the later stages, and the timely use of theanine products can effectively alleviate anxiety in the early stages, helping adolescents adjust in time, prevent the generalization of anxiety, and avoid more serious consequences.
Our reflection: Dr. Xinyuan Zhou's proposal has provided us with further clarity on the timing of the release of theanine — the earlier the intervention of theanine in anxiety, the better, but in this stage, we still lack clear indicators to judge the level of anxiet
Interview content:
In order to further understand the current situation of anxiety among children and student-age groups, we interviewed Director Lin Wang, who is the chief physician, professor, and doctoral supervisor at the Capital Institute of Pediatrics. She is currently the executive director of the Health Care Center. She has extensive experience in the fields of children's growth and development, psychological behavior, and learning difficulties. In terms of academic part-time jobs, Lin Wang serves as the director of the Children's Early Development Committee of the China Maternal and Child Health Association, the vice chairman of the Children's Health Branch of the Chinese Preventive Medicine Association, and the leader of the Maternal and Child Health Group of the Primary Health Care Promotion and Continuing Education Committee of the National Health Commission, among other important positions.
Dr. Wang stated that in the relevant clinics, it is usually the caregivers who bring the children for medical treatment. They often judge by noticing changes in the child's body, such as feeling down, poor sleep quality, etc. She believes that children who take the initiative to seek medical treatment are no more than 5% of all patients. Most children are unwilling to admit that they have psychological problems and usually do not like to communicate with the outside world. When parents discover the situation, it is at least a state of anxiety, and social functioning has already deviated and abnormal. Sometimes parents may think it is adolescence or other reasons and let it go, but in fact, the child has already shown early signs. Schools and families are the two most frequent scenarios for adolescents, and it is an important task to let parents and teachers understand how to identify the corresponding symptoms.
In addition, she also mentioned that the presence of psychological diseases such as anxiety has occurred more in lower ages in the past two years, from high school students to third and fourth graders who will have similar situations, and these trends cannot be ignored. This has strengthened our idea of focusing on the adolescent group.
Dr. Wang also talked about the main causes of psychological problems: the first is parent-child conflicts, mainly academic conflicts; the second is excessive screen exposure, including long-term contact with mobile phones, surrounded by negative news, etc.; the third is academic pressure, too much homework, etc. On the contrary, factors that alleviate related problems include the number of good friends. Studies have shown that if the number of good friends exceeds four, the probability of children having psychological problems will be greatly reduced. Benign interaction with friends can greatly promote the venting and release of emotions; outdoor activities, outdoor activities increase dopamine, and are generally carried out with partners, playing a positive role. Moreover, exercise can enhance a positive mental state and increase the positive cycle of overcoming difficulties, enhancing internal motivation. She also said that we can explain to children how to identify their own problems, recognize related signs, and how to seek help, etc. She also pointed out that she believes that popular science lectures for parents and teachers are more meaningful. This information has been of great help to our subsequent educational science popularization.
Additionally, Dr. Wang also suggested that we start from the perspective of health care products. Theanine products can be taken when exam pressure and other pressures occur.
Summary:Through our interview with Director Wang Lin, we've learned that anxiety often goes unnoticed in children until it's advanced. The timely introduction of theanine supplements can help mitigate early symptoms, aiding adolescents in coping, preventing anxiety escalation, and steering clear of severe outcomes.
Our reflection: Combining Dr. Wang's interview and the survey questionnaire, we have focused our target audience on adolescents. In addition, we have taken Dr. Wang's advice and started the preparation of popular science lectures for community and school .
Interview content:
To better understand the causes of anxiety, we interviewed Dr. Chuyuan Wang, a chief physician at the Department of Psychiatry at Guang'anmen Hospital, part of the China Academy of Chinese Medical Sciences. Dr. Wang specializes in the treatment of insomnia, sleep phase disorders, parasomnias, somnambulism, and other sleep disorders, as well as depression, anxiety, acute stress disorders, phobias, and somatoform disorders. He graduated from Beijing University of Chinese Medicine and pursued his postgraduate studies at the China Academy of Chinese Medical Sciences. Currently, he works in the Sleep and Psychiatry Department at Guang'anmen Hospital. Dr. Wang also serves as the executive director of the Professional Committee on Traditional Chinese Medicine Psychology within the World Federation of Chinese Medicine Societies. In his clinical practice, he employs non-pharmacological treatments, such as acupuncture, massage, and cupping, to create personalized treatment plans. Dr. Wang is also committed to educating young doctors by continuously enhancing their clinical knowledge in both traditional and modern medicine. The purpose of this interview is to understand the role of L-theanine in managing anxiety and to prepare for future public education campaigns.
Dr. Wang emphasized that stress is one of the most significant factors in emotional disturbances. However, he noted that the development of mental illness is a complex process involving not only stress but also genetic predisposition, environmental factors, personality, and family dynamics. In everyday life, when individuals encounter stress, it can act as a trigger for mental disorders. He mentioned that the most common emotional responses to stress are anxiety and depression. He further explained that anxiety and depression are the primary emotional manifestations of mental disorders. In addition to emotional disorders, mental illnesses also include cognitive disorders, such as logical thinking impairments, which may lead to conditions like schizophrenia. The diagnosis of mental illness is fundamentally different from diagnosing physical conditions like colds or fevers. Currently, there are no objective diagnostic markers, such as blood tests or imaging, to definitively diagnose mental disorders. The core diagnostic criteria for conditions like anxiety are based on symptoms. Commonly used diagnostic tools are various rating scales, but the final diagnosis relies on the physician's comprehensive evaluation of the scales and diagnostic criteria.
Additionally, Dr. Wang acknowledged the positive role of L-theanine and mentioned that most anti-anxiety and antidepressant medications on the market are often interchangeable. However, he cautioned that while medications can be effective, they may also carry risks of dependency and addiction. Antidepressants typically do not cause dependency but require some time to take effect.
Dr. Wang emphasized that public education and awareness of mental health are critical in helping people understand these conditions, alleviate fears, and encourage early recognition and effective intervention. He suggested focusing public education efforts on how to identify symptoms of anxiety and depression, promoting the impact of healthy habits on emotional well-being, and teaching individuals how to recognize and adjust negative thinking patterns.
Introduction to Rating Scales
- GAD-7 (Generalized Anxiety Disorder 7-item scale): A short self-report questionnaire widely used to assess generalized anxiety disorder (GAD). It includes seven items designed to evaluate the frequency and severity of anxiety symptoms over the past two weeks. The GAD-7 scale is well-regarded for its simplicity and effectiveness, making it widely used in both clinical and research settings.
- Hamilton Anxiety Rating Scale (HAMA): A scale used to assess the severity of anxiety symptoms. The HAMA consists of 14 items that measure both somatic and psychological anxiety, covering aspects such as anxious mood, tension, fears, insomnia, cognitive function, and depressive mood.
- Montgomery-Asberg Depression Rating Scale (MADRS): Although primarily designed to assess the severity of depressive symptoms, the MADRS can provide valuable insight into a patient's overall emotional state, including elements that may overlap with anxiety.
Summary: Through our interview with Dr. Wang Chuyuan, we've learned that while stress is a significant factor in emotional disturbances, mental illness development is multifaceted. Early intervention with L-theanine is beneficial, and education on mental health is essential for early recognition and treatment, potentially preventing more severe outcomes.
Our reflection: In the interview with Director Wang, Director Wang answered our previous uncertainty about the evaluation criteria for anxiety level, and gave four professional assessment scales, including self-measured types and other measured types, which were distributed by us in the later activity as a way to help people identify anxiety. In addition, Director Wang suggested that we put the focus of science popularization on people's understanding of anxiety, and this is a great help to the development of our later activities.
Our team conducted a thorough investigation into the production methods currently used by certified commercial suppliers of L-theanine. By leveraging various platforms, we set out to gather detailed information about the production techniques employed by these suppliers. To streamline the process, we created an online spreadsheet and identified a total of 74 suppliers. The tasks were distributed among our team members, with each person assigned a group of suppliers to contact.
Our team utilized a variety of methods to gather information, including sending direct messages to customer service representatives, making phone calls, and conducting follow-up inquiries. Although a significant number of suppliers did not respond to our queries, we still managed to obtain valuable data from the responses we received.
From the effective responses, we found that the majority of suppliers continue to rely on the most traditional method—plant extraction—to produce L-theanine. Following plant extraction, the second most common method reported by suppliers was chemical synthesis. Additionally, some suppliers employed enzymatic methods.In addition to gathering data on L-theanine production, we also received detailed information regarding the production process of tea polyphenols from one of the suppliers.
Despite the challenges posed by the lack of responses from many suppliers, our team’s efforts were rewarded with enough data to establish a clearer picture of the current industry practices.
Summary:Through our comprehensive investigation, we discovered that plant extraction is the predominant method for L-theanine production among commercial suppliers, followed by chemical synthesis and enzymatic methods. This insight, coupled with additional details on tea polyphenol production, provides a clearer view of industry practices despite the challenges faced in data collection.
Interview content:
In order to better understand the potential of theanine in alleviating anxiety, we interviewed Dr. Lina Li. She is a chief physician and associate professor at Dongzhimen Hospital of Beijing University of Chinese Medicine, with a medical doctorate and a visiting scholar at Duke University in the United States. Dr. Li is currently engaged in the research of the integration of traditional Chinese medicine and modern biology, focusing on the molecular mechanisms of classical prescriptions for the treatment of difficult diseases. She has extensive clinical experience in the treatment of endocrine, metabolic, and immune system diseases, and has presided over several national scientific research projects. At the same time, as a director of the World Federation of Chinese Medicine Society of Classical Prescriptions, she has made outstanding contributions to the internationalization of Chinese medicine and scientific research innovation. The main purpose of this interview is to explore the application of theanine and how it can help alleviate anxiety from the perspective of traditional Chinese medicine.
Dr. Li first introduced theanine, a natural component derived from tea leaves that has garnered attention for its ability to regulate neurotransmitters. Theanine can promote the release of dopamine and serotonin in the brain, thereby effectively alleviating anxiety, relaxing the nerves, and improving sleep quality. Dr. Li pointed out that theanine, as a component with the characteristics of both food and medicine, has been extensively studied and has shown significant effects on mood management. Especially in modern society, where the incidence of anxiety and depression is gradually increasing, theanine can serve as a natural adjunct therapy. Dr. Li believes that synthetic biology is generally faster than other methods, with larger synthesized molecules and clearer synthetic pathways in biological systems. Considering from the perspective of initial synthesis, it is important to find relevant synthetic enzymes and optimize the entire synthetic pathway. The artificial starch synthesized from methanol is a good example. She pointed out that synthetic technology can not only increase production but also ensure the purity of the components, which is a huge advantage for the application of synthetic theanine.
When discussing the role of theanine in anxiety disorders, Dr. Li expressed a positive view. She pointed out that theanine, as an over-the-counter natural component, can effectively soothe anxiety emotions with fewer side effects. She affirmed that theanine is suitable for early emotional regulation and anxiety prevention, especially among adolescents, helping them to self-regulate in time when facing academic pressure and anxiety in life. Dr. Li believes that theanine has great potential, and the theanine-based "energy" drinks sold in the market are a good example.
Regarding our idea of making a theanine humidifier, she suggested we research whether it has any irritation to the respiratory system. Dr. Li also advised that according to her experience, theanine would be hard to absorb when delivered through humidifier mist. Dr. Li suggested that since most drugs absorbed by the nasal mucosa are required to be lipophilic, and theanine, which is similar to glutamate, is highly water-soluble rather than lipophilic, it should be difficult to be absorbed through the nasal mucosa.
At the same time, she believes we need to clarify the dose-response relationship of theanine.
However, she reminds us that although theanine can help relieve stress at a certain dose, its effect is not "magical," and it is more suitable as a preventive or auxiliary means for mild emotional regulation.
Summary: Through our interview with Dr. Li Lina, we learned that theanine, a natural compound from tea leaves, can help alleviate anxiety by modulating neurotransmitters with minimal side effects. It holds promise as a preventive measure for early emotional regulation, particularly beneficial for adolescents facing stress. However, its efficacy as a standalone treatment for severe anxiety is limited and should be considered as an adjunct therapy.
First, we verified Dr. Li’s suggestion on the nasal absorption of theanine. In literature reviews, we didn’t find direct study of either theanine or its close structure analog, glutamate, in the context of nasal absorption. We did find articles about increasing nasal drug administration using various nanoparticles or adhesives of neuroprotective drug [Sinswat et al., 2003; Sood et al., 2014], which suggest the absorption of theanine is not easy. Developing strategies using nanoparticles to enhance adsorption sounds interesting but given the limited time we have for trial and errors but decided to change to other theanine delivery methods. This sparked our investigation of making candies with theanine and making a timer-controlled candy box.
Second, we reviewed the literature to better understand the dose-response relationship of theanine, addressing Dr. Li's concern. According to multiple studies, the typical dosage of theanine that produces notable effects on stress reduction and anxiety relief ranges between 200 mg and 400 mg per day. For instance, several trials indicated that 200 mg of theanine administered orally in healthy adults showed significant reductions in stress markers such as heart rate and salivary immunoglobulin A, both physiological indicators of stress. Additionally, studies in both healthy individuals and those with mild anxiety or depressive disorders reported improved cognitive performance and reduced anxiety symptoms with daily theanine doses of around 250 mg.
Given this evidence, we considered Dr. Li’s suggestion that precise dosing is critical. Since most studies showed effects with doses ranging from 200 to 250 mg per administration, we adjusted our delivery method plan accordingly to ensure a safe and effective dose for our product. Instead of using the humidifier, which had potential limitations in absorption, we decided to explore oral administration methods, such as lozenges or chewable tablets, which can more accurately control theanine intake.
Interview content:
Professor Sen Wu is currently a professor in the Department of Biochemistry and Molecular Biology at the College of Biological Sciences, China Agricultural University, with extensive experience in scientific research and teaching. He received his undergraduate education at the College of Veterinary Medicine, Beijing Agricultural University, and then pursued a master's degree at the University of Saskatchewan in Canada. Professor Wu obtained his Ph.D. at the University of Utah in the United States, where he continued his postdoctoral research under the guidance of Nobel laureate Professor Mario Capecchi, focusing on animal genetic engineering and stem cell research. Since 2010, Professor Wu has been a professor at China Agricultural University, teaching "Advanced Animal Physiology and Molecular Biology," and has made significant contributions to animal genetic engineering and stem cell research.
Enhance production efficiency: Since the production method for theanine is already mature, using synthetic biology to improve production is crucially about enhancing production efficiency. Regarding enzymes, it is necessary to search the literature to understand which of the five enzymes is the rate-limiting step, and build upon the foundation of previous work to conduct further experiments. Additionally, production can be accelerated by adjusting fermentation conditions (pH value, temperature, nutrient components), changing the induction time point of IPTG, or altering the gene, promoter (there might also be a need to adjust the inducing enzyme). References can be obtained from the Molecular Cloning Manual, "molecular colony menu."
How to maintain rigor in experiments: The most important aspect of an experiment is its repeatability. If a success that occurs only once by chance is considered as the success of the entire project, it is not rigorous enough. However, when multiple experiments are successful, they can be more rigorously considered as successful. Keeping experimental records can ensure the rigor of the experiment. It is essential to clearly document every step of the experiment, with a complete experimental plan and protocol. Rigorousness can be tested by changing different variables and conditions to understand which ones are the most important, thus achieving the most rigorous and repeatable conditions.
How to detect the formation of theanine during fermentation: Since it is not within the professor's field of research, some general methods are suggested. For example, PCR can be used to detect specific fragments of DNA and RNA. There are also specific antibodies for theanine detection, and methods such as Western blot, ELISA, and mass spectrometry can be employed.
Considerations for the extraction process after theanine production: Due to the high solubility of theanine, it is necessary to consider how to design the extraction of theanine from the fermentation broth. Common methods include centrifugation, filtration, resin adsorption, etc. He suggested that our team could refer to literature to see what processes have been used for extraction in the past.
Compared to the chemical synthesis of theanine, what are the advantages of using synthetic biology: Professor Wu mentioned that the materials produced by biological methods come from renewable biological resources, which is beneficial for long-term development. Compared to chemical manufacturing, consumers might perceive the products as having toxic side effects. However, with synthetic biology, consumers feel that the products are more natural and are more readily accepted.
Summary: Through our discussion with Professor Wu Sen, we learned that enhancing theanine production through synthetic biology can improve efficiency by optimizing enzymes and fermentation conditions. Rigorous experimental practices are crucial, and various detection methods can confirm theanine synthesis. Post-production, extraction methods like centrifugation and filtration become critical. Synthetic biology offers a renewable and consumer-friendly advantage for theanine production.
Our reflection: Professor Wu answered our previous questions in the experiment, mainly about production efficiency and further improvement of production technology, and then we discussed with him about ensuring rigor in the experiment process. He helps us find a more proper way on production. In addition, we discussed the advantages of synthetic biology on theanine, and Professor Wu believes that in addition to advantages such as renewable and long-term development, it is more acceptable to people.
Motivation: In our project design, L-Theanine will be synthesized in bacteria culture, and then be extracted from the culture liquid and prepared into powder form for downstream uses. We do not have the facilities and conditions to perform such an extraction, but we contacted an expert in this field to learn about the industrial processes and potential challenges. The company is not an active player in producing L-Theanine, but it manufactures a very closely related substance, GABA (Gamma-Aminobutyric Acid), which is often associated with L-Theanine in anxiety relief. The manufacturing process also shares a lot of common techniques.
Interview content:
In order to gain a deeper understanding of the preparation process of GABA (Gamma-Aminobutyric Acid) and the current market demand, we interviewed Mr. Zhuo Li, the Production Technology Manager of Liaoning Tianhua Biopharmaceutical Co., Ltd. Mr. Li has extensive experience in the field of biological fermentation and is committed to the research and application of microbial fermentation technology. We conducted an interview on the basic principles of microbial fermentation, the production process of GABA, quality control, and other aspects. Through this interview, we hope to understand various aspects of microbial fermentation and specific technologies to improve our experimental output.
Mr. Li first introduced the microbial fermentation method, stating that microbial fermentation is a process that uses microorganisms under specific conditions to convert raw materials through specific metabolic pathways into the products we need. In addition to the biological fermentation method, Mr. Li introduced several mainstream technologies, including enzyme synthesis and chemical synthesis. He pointed out that chemical synthesis, due to its greater pollution, is gradually being replaced by microbial fermentation and enzymatic methods. The microbial fermentation method and the enzymatic method are very similar in production mechanism, with the difference being that the former directly uses microbial strains for the reaction, while the latter relies on immobilized enzymes to complete the reaction. The advantage of the microbial fermentation method is that it causes less environmental pollution, produces less waste during the production process, and can eliminate the environmental risks brought by microbial strains through high-temperature sterilization. Taking the microbial fermentation method as an example, Mr. Li explained how GABA is generated through specific microbial strain reactions. In terms of production steps, Mr. Li said that through the fermentation method, sodium glutamate is used as raw material, and a specific microbial strain is used to convert glutamate into GABA through decarboxylation reaction. This process takes into account the stability and efficiency of fermentation conditions. The cultivation process uses sodium L-glutamate as raw material, which is fermented by Bacillus cereus, followed by sterilization, cooling, and filtration treatments. The entire process requires strict control of temperature, pH value, and oxygen supply to ensure that the microbial strains grow in the most suitable environment and produce enough GABA. Regarding product quality control, Mr. Li added that in the production, glutamate is mixed with microbial strains for fermentation, and finally, after sterilization, cooling, and filtration processes, a high-purity product is obtained. To ensure product quality, the enterprise has set strict quality control measures at every link, from raw material procurement to finished product testing, all of which must meet the standards. The above information provides valuable reference for our fermentation experiments.
Regarding the purification and powderization part of the fermentation method, Mr. Li emphasized that first, it is necessary to generate glutamate through microbial fermentation. After the reaction is completed, the acidic product exists in the aqueous solution. By filtration, the bacterial residue is removed to obtain a clean aqueous solution containing phosphate. Then, the proteins produced by fermentation are removed by filtration again. Subsequently, low-temperature vacuum evaporation is used to avoid high-temperature decomposition of the product and to remove most of the water, but not completely dried. For the powderization process, Mr. Li once again emphasized that it is necessary to add alcohol solvents to precipitate insoluble aminobutyric acid, and through separation, a low-concentration alcohol solution is obtained, and aminobutyric acid precipitates out. After further filtration, the wet solid product is obtained. Finally, through the drying process, the residual alcohol solution is evaporated, and thus, the dried powdery aminobutyric acid product is obtained. This process has been of great help to us.
Although microbial fermentation technology is relatively mature, Mr. Li pointed out that the industry still faces some technical challenges. For example, the stability of microbial strain cultivation and the control of impurities during the fermentation process are still difficult issues. At the same time, the development of synthetic biology and genetic engineering technology has brought new opportunities to this field, and more and more enterprises are trying to improve fermentation efficiency through genetic modification. In the future, genetic engineering methods may become an important direction for optimizing fermentation processes. Mr. Li added. Regarding the market demand for products such as GABA and theanine, Mr. Li believes that there has been a clear upward trend in recent years, especially in the fields of functional food and health care products, where their applications are continuously expanding. As for our product plan, Mr. Li said that the forms of pressed candy and functional beverage powder are indeed competitive in the market, easy to carry and easy to take, and further improvements can be made in the solubility and taste of the products.
Summary: Through our interview with Mr. Li Zhuo, we learned about the microbial fermentation process for producing GABA, which is more environmentally friendly than chemical synthesis. We gained insights into optimizing fermentation conditions for efficiency and the importance of quality control measures. Additionally, we explored the challenges in strain cultivation and the potential of genetic engineering to advance fermentation processes. Mr. Li also highlighted the rising market demand for GABA and related products, particularly in functional foods and health care, suggesting that our product forms like pressed candy and beverage powders are well-aligned with market trends.
Our reflection: The production process of GABA has given us a lot of inspiration and enlightenment, and the conversation with GABA producers further confirmed the advantages of our choice of microbial fermentation method. After the interview, we decided to continue researching on pressed candy and functional beverages as product forms, which are more in line with market choices.
Interview content:
To gain a deeper understanding of the production process and safety evaluation of L-theanine, we interviewed Mr. Lifu Wei, the head of R&D at Liaoning Chengda Biotechnology Co., Ltd. Mr. Wei is responsible for the registration of health supplements and has extensive research and development experience, focusing on driving innovation and promoting health products to the market. His team has made significant progress in the field of health supplement development, particularly in meeting market demands and ensuring regulatory compliance. We also spoke with Dr. Jing Wei, a senior consultant at the Liaoning Provincial Institute for Drug Control, a second-level chief pharmacist, and a PhD holder. She is a recipient of the State Council's special allowance and a distinguished expert in Liaoning Province. With over 30 years of experience in pharmaceutical and medical device regulation, Dr. Wei has contributed to the development of several national drug regulations and major research projects for the Ministry of Science and Technology. She serves as an expert reviewer for the National Medical Products Administration (NMPA) in the field of health supplements and has been instrumental in advancing China's quality management systems for pharmaceuticals and health supplements.
In this interview, we delved into the production process of L-theanine, its market applications, and the safety evaluation procedures. We explored each critical step involved in bringing L-theanine products from raw material selection to market, as well as the regulatory requirements that must be met.
Dr. Wei explained the different focuses during the research, development, production, and marketing stages of health supplements and pharmaceuticals. The pharmaceutical development process is rigorous, encompassing preclinical trials, three phases of clinical trials, and post-marketing surveillance, with a strong emphasis on proving efficacy and safety and adhering to strict dosage requirements. Health supplements, on the other hand, primarily focus on functional evaluations and ingredient safety. Their development revolves around ingredient selection and process design, and before they are marketed, a series of toxicological and functional tests must be completed, although complex clinical trials are not required. Since health supplements target healthy individuals rather than treating diseases, market promotion relies more on highlighting product functionality and gaining consumer trust.
Dr. Wei emphasized the three key stages of process development: small-scale laboratory research, pilot-scale studies, and large-scale production after approval. She explained that the small-scale phase is crucial for ensuring the feasibility and stability of fermentation processes. The pilot-scale stage tests the process’s scalability, laying the groundwork for future industrial-scale production. She recommended that research teams refer to the "Health Supplement Registration Service Guide," especially the relevant chapters, to further optimize the development process. Regarding the specific steps in safety evaluations, Dr. Wei detailed procedures including acute toxicity, chronic toxicity, mutagenicity, and carcinogenicity tests. She also stressed the importance of identifying and assessing the safety of microorganisms used in fermentation to ensure their safe use in products. Additionally, she mentioned the importance of following national food safety standards (such as GB 2760) for excipients used in tablet candy and powdered drinks, advising the use of comparable product formulations. Dr. Wei recommended that the manufacturing process meet the hygiene standards required for oral solid dosage pharmaceuticals to ensure product safety and quality.
Regarding the regulatory pathway for L-theanine as a health supplement, Dr. Wei explained that products must undergo either a filing or registration process before entering the market. Filing is relatively simple and is suitable for well-established ingredients with a proven safety record, while registration requires more comprehensive toxicology and efficacy testing. As L-theanine is a newer health ingredient, if it is produced through microbial fermentation, it may require registration and a series of tests, including animal studies and efficacy tests, to ensure both safety and functionality.
Mr. Wei pointed out that due to significant differences in raw materials and processes between fermentation-based and plant-extraction methods, L-theanine produced via fermentation would need to undergo a new food ingredient registration process. This would involve providing comprehensive data, including toxicological, safety, and efficacy studies. He recommended referencing similar fermented products that have already passed safety evaluations to expedite the approval process.
When asked about the product forms of L-theanine and possible improvements, Mr. Wei suggested that tablet candy and powdered drinks are suitable formats for market promotion, as they are easy to carry and consume. However, he recommended enhancing product solubility and improving taste. He also emphasized that excipients used in the production of health supplements must comply with relevant national standards. Excipients used in tablet candy and powdered drinks should not only meet functional needs but also ensure the safety and stability of the product. Mr. Wei provided two relevant regulatory documents for us to study: Health Supplement Functional Testing and Evaluation Methods (2023 Edition), Health Supplement Registration Technical Review Guidelines, Health Supplement Registration and Filing Procedures, Health Supplement Registration Service Guide, New Food Ingredient Application and Acceptance Regulations, and New Food Ingredient Safety Review Procedures.
Summary:Through this interview, we gained a thorough understanding of the current safety assessment process for L-theanine, as well as the compliance required for subsequent activities. For our hardware products, we obtained food grade theanine from certified commercial suppliers and considered additive and agent materials that are only food grade.
Our Reflection: Through the interview with pharmaceutical and health supplement evaluation experts, we obtained guidance on meeting regulatory standards, which is crucial for our product development. Understanding regulatory requirements help us avoid delays or increased costs due to non-compliance in the later stages of product development. We have come to appreciate the importance of conducting safety tests, including toxicological assessments, to ensure that our products are safe for consumers. In terms of product form, we further delve into the significant role played by solubility and taste improvement.
Motivation: To learn about application areas of anxiety relief additives and new product implementations from the market.
Interview content:
We had the privilege of engaging in a profound dialogue with Zhijing Sun, the Sales Director of Liaoning Tianhua Bio-Pharmaceutical Co., Ltd., delving into the market demand and application areas of anxiety relief substances that is usually taken as food supplements or additives, such as L-Theanine, Gamma-Aminobutyric Acid (GABA) and similar products.
Director Sun pointed out that the application areas of anxiety relief supplements are extremely broad, initially primarily promoted for sleep improvement, and now extended to various aspects including emotional health, children's growth, sports, and even beauty/fashion. The dosage forms have evolved from tablets and solid beverages to oral liquids, candies, chocolates, and more. The market demand continues to grow with its increasing acceptance among consumers, especially in the areas of sleep aid and emotional health.
Sun also emphasized that the products vary for different user groups. Children's products may focus more on their growth-promoting characteristics, while products aimed at office workers may emphasize alleviating emotions and improving sleep. Products for the elderly may concentrate more on the auxiliary benefits for diseases like hypertension. The efficacy claims of these products need to be determined based on the target population and product characteristics.
Sun also mentioned that the market size is continuously growing. It is predicted that the global market sales will increase from $110.12 million in 2022 to $196.86 million in 2029, with a compound annual growth rate (CAGR) of 8.08% from 2023 to 2029.
Sun also mentioned there is a trend to combine the use of different anxiety relief substances, such as L-Theanine and GABA (Gamma-Aminobutyric Acid), because of their shared nerve-soothing effects, making them frequent companions in sleep-related products. There have been customer requests for products with a two-to-one ratio of GABA to theanine, but currently, there is no specific clinical data, and product efficacy is primarily judged based on consumer feedback.
Summary: Through our discussion with Director Sun, we discovered that anxiety relief supplements are diversifying into broader applications like emotional health and sports, with an expanding market size expected to grow significantly by 2029. The trend towards combining substances like L-Theanine and GABA for sleep enhancement without concrete clinical backing, yet guided by consumer feedback, underscores the evolving landscape of the industry.
Our reflection: In our conversation with Director Sun, we gained insights into the market development of our product as an anxiety relief supplement and made predictions for the future of our product. Judging by the current situation, the market size will continue to grow, and the application of theanine in the market will become more and more widespread.
The school cafeteria is one of the places where students gather frequently for lunch and dinner. Most of our school students come to the cafeteria, thus ensuring that our promotional activity can reach more students. Compared to other promotion activity venue, such as classrooms and libraries, the cafeteria has a more relaxed atmosphere, so students are expected to be more receptive to new information. Getting beverages in the cafeteria is a daily habit for most students, and introducing our promotional messages through this activity feels more natural.
Therefore, giving away free beverages containing theanine, would allow students to understand the potential benefits of theanine in alleviating anxiety through actual experience.
Through this activity, we hope to raise students' interest and attention to knowledge about anxiety disorders through the fun way. We also hope to encourage students to choose healthier beverages.
For every student who came to our booth, we distributed a cup of the theanine beverage, and did poster promotion. Our team members introduced knowledge about anxiety disorders and the benefits of theanine to students through posters. We used questionnaires to learn about students' anxiety status to understand their self-perception and coping methods for anxiety. For students showing higher interests in anxiety, we offered further resources and suggestions, encouraging them to seek professional help.
Through this activity, we hope to raise students' awareness of anxiety disorders and promote a healthy lifestyle, safeguarding the mental health of students.
Wechat which has over a billion monthly active users is one of the most popular and powerful social media platform in China. Since Wechat Official Accounts enable influencers and organizations to post content, we decided to publish passage about synthetic biology knowledge and our project——Theanine for anxiety treatment.
On July 26th, we posed our first passage——What is synthetic biology. Since we were very concerned about whether the audience could understand the article rather than being overwhelmed by a large number of technical forms, our team members tried every possible way to explain complex knowledge in an engaging way. To be more specific, we started with everyday phenomena, such as lab-grown meat and synthetic spider silk to catch the audience’s eye. Then, we began to discuss synthetic biology’s historical development, its interdisciplinary advancements, the differences between synthetic biology and biosynthesis, and two approaches to synthetic biology in the following paragraphs. Winnie Xiong even used metaphor. For instance, she compared the appearance of plasma necklace which made readers to imagine, and be more interested to read. To test whether our article could be clearly understood by those who were unfamiliar with synthetic biology, we let six people from different ages to read our content before publishing it. After reading our passage, some gave us suggestions, like adding some illustrations. Thus, Winnie Xiong drew some pictures which could support our content. Within 24 hours of publishing the first article, we gained 60 subscribers from various regions in China, and the view count reached 328. The subsequent two articles also resulted in a net increase of 39 followers.
Finally, "What is Synthetic Biology" garnered 998 views and over 90 likes. As the number of articles published increased, approximately three individuals commented in the discussion section, sharing their suggestions and improvement methods for the content of the Official Account. They also expressed their viewpoints and understanding of the article's content. Ultimately, they brought our articles to their teachers for discussion, which made us very happy. Now, we continue to post one passage each week.
To promote knowledge and preventive measures related to anxiety disorders, our team set the target audience within the community. This is because there was a large number of community residents, with a predominance of young people aged 6 to 22, most of whom have not previously learned about anxiety-related topics. Therefore, this was very beneficial for our presentation. During the presentation, there were almost 50 residents attended. We discussed the symptoms of anxiety disorders, the difference between anxiety and anxious feelings, prevention methods, self-diagnosis, and relevant scales. At the beginning, Wanchen Kai defined anxiety disorders using clear language. Considering that the audience consists of community members who may not have much understanding of biology and related terms. Therefore, we avoided using overly technical jargon during the introduction and while creating the PowerPoint presentation.
Then, Wanchen Kai compared normal anxiety, anxious states, and anxiety disorders to help the audience understand the differences among the three. Besides, we used comparison of causes and comparison of symptoms to make it easier for to understand the reasons. Our adopted a multi-faceted analysis, examining the causes from psychological, physiological, and environmental perspectives to comprehensively showcase the complexity of anxiety disorders. Given the intricate nature of anxiety disorder causes, a multi-faceted analysis helped the audience gain a thorough understanding. Also, we briefly introduced several commonly used self-assessment scales for anxiety disorders to provide reference. Emphasizing the limitations of self-assessment scales and recommending that individuals with severe symptoms seek medical attention, highlighting the importance of professional healthcare. For those who suspected they had an anxiety disorder, self-assessment was the first step, but a professional medical diagnosis was crucial for accurate diagnosis. Additionally, we specified that a medical diagnosis was preferable to avoid misleading the audience.
Besides, we also did a pre-test and a post-test among our audiences, to test whether they understood our speech and satisfied with our performance, helping us to improve and do better in the future. Here are some parts of our tests, as well as our PowerPoint content:
Fig.1 Assessing the understanding of anxiety disorders before the presentation.
Fig.2 Assessing the understanding of anxiety disorders after the presentation.
Fig.3&4 Satisfaction test
In addition to community outreach, we organized a science outreach at our school to raise awareness among students and teachers about the causes of anxiety and how to identify early symptoms. We gave lectures to more G10 and G11 students and several teachers, as well as orgnized seminars among teachers towards the issue. We emphasized that the primary cause of psychological issues is parent-child conflict, especially academic-related conflicts. The second cause is excessive screen exposure, such as prolonged phone use and being surrounded by negative information. The third cause is academic pressure, including too much homework. On the other hand, one way to reduce stress is to have more friends. Research shows that if a child has more than four friends, the likelihood of developing psychological problems is greatly reduced, as positive peer interactions help release emotions. Outdoor activities also play a beneficial role by increasing dopamine and promoting a positive mental state, especially when done with friends. Exercise encourages a cycle of positivity and internal motivation, helping people overcome challenges. We also discussed how to help children recognize symptoms in themselves and seek help when needed. We believe this information is important for parents, teachers, and students.
With the fast-developing technology today, we are presenting our experiments on online platforms. Also, we posted educational blogs.Firstly, we selected Weibo because of its high inclusivity and significant presence of young people, making it likely that many users would be interested in our project and the popular science content we create. Additionally, our promotional efforts can reach and influence even more individuals. Another reason is that we've discovered many iGEM teams from other regions on Weibo, which greatly facilitates communication and collaboration between our teams. Finally,Ruoxi Li has been actively managing my Weibo account, so she was quite familiar with the platform and has built a decent following.Current Progress: We've gained 144 followers, received 49 likes, and achieved 609 views!
Besides these, our account is not just a platform for sharing information; it's a space where we listen to your thoughts and feelings. You are always welcome to reach out to us through DM—whether you want to vent, share your stories, or simply express yourself. We will anonymously share these messages with our community for open discussion, allowing more people to join in. Here, you can freely release your emotions, relieve stress and anxiety, and find connection and support.
The school sports event is one of the most important activities in our school that everyone in the school, including teachers and staffs are all involved in the event. During the school sports event, we organized an educational campaign on anxiety, aiming to raise awareness among students about the symptoms of anxiety and offer coping strategies. The campaign followed this structure:
Poster Creation and Display: Prior to the start of the event, we carefully designed an educational poster with guidance from Chief Physician Wang Chuyuan. The poster covered the development of anxiety and its generalized effects, detailing the symptoms at different stages. On the other side of the poster, we provided tips on how to manage anxiety, helping students recognize negative thoughts and adjust them effectively.
L-Theanine Beverages Distribution for Athletes: After researching various L-theanine beverages, we selected an electrolyte drink that was suitable for athletes. At the event, these beverages were placed at the entrance for athletes to pick up. Considering that many athletes experience nervousness and anxiety before their competitions, the L-theanine in the drink offered a calming effect. The feedback from the athletes was overwhelmingly positive.
Awareness Campaign and Questionnaire Distribution: After the athletes had entered the event, we moved our campaign to the spectator stands to reach more students. We also handed out self-assessment questionnaires recommended by Dr. Wang—specifically the GAD-7 questionnaire—to help students evaluate their anxiety levels. The GAD-7 (Generalized Anxiety Disorder 7-item scale) is a widely used tool for assessing generalized anxiety disorder. It consists of seven items designed to measure the frequency and severity of anxiety symptoms over the past two weeks. Due to its simplicity and effectiveness, the GAD-7 is commonly used in both clinical and research settings.
Through this well-organized campaign, we successfully raised awareness of anxiety symptoms, provided practical self-assessment tools, and effectively educated students on anxiety and coping mechanisms.
We participated in an online iGEM team exchange seminar. We first attentively listened to the first team's project presentation. Then, Xiwen Xiong introduced the overall concept of using theanine to treat anxiety, covering the project background, traditional treatment methods, and theanine's function and purpose. During the presentation, Leyi Li actively explained the experimental process and shared results and insights from promoting theanine's anxiety-relieving effects during a sports event. Finally, Wanchen Kai gave a lecture on what anxiety is and how to alleviate it. After all the teams had presented, our group asked several engaging questions, mainly focusing on educational aspects. For example, we asked how the other team contacted university students to successfully host their lectures, whether the number of participants in their surveys was sufficient, and if they used a combination of online and offline methods for promotion. Since the host had previously participated in an iGEM competition, we also inquired about the defense process, preparation strategies, and received satisfying responses.
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