Depression is one of the most common mental illnesses today, with continuous and long-term low mood as the main clinical feature, and is the most important type of modern mental illness. At present, there are about 322 million people with depression in the world. Fortunately, some clinical studies have shown that oral 5-HTP improves depressive symptoms. It was found that taking 150-3000 mg daily for 2-4 weeks improves depressive symptoms. What's more, some earlier studies have suggested that 5HTP May be as beneficial for some people as traditional antidepressant therapy. Another chemical that is related to the improvement of depression is GABA, which has been proved to have some roles when cure the depression.
After conducting our preliminary hands-on research to make a more accurate conclusion, our ultimate goal is to put the product into use and use it widely in the treatment of depression. Due to the particularity of this drug, we have analyzed the pros and cons and drug dosage methods in a multi-dimensional manner in comprehensive human practice. For any commercially profitable product, business planning is very necessary.
Targeting users
Since the team designed a synthetic biology strain based on Escherichia coli 1917 EcN that produces 5-HTP and GABA, this strain can reduce fear, anxiety and stress, improve sleep quality, lower blood pressure, and improve patients' mood. Improve sleep quality and relieve pain.
As a health care drug for the general public, probiotics should not only be limited to fixed depression patients but should be widely available to the public. The strains developed by our team are not only for patients suffering from mild to moderate depression, nausea, loss of appetite, sighing, insomnia and dreaminess, but also for people who have been living in a high-pressure and fast-paced lifestyle for a long time, office workers and Students, etc. can use probiotics.
This is a common prescription drug for major depression currently on the Chinese market. The chart shows the target and biological treatment of the product. Our products are different from these common ones on the market and have their own new mode of action and biotechnology. There are more options for patients, and the treatment effect is better.
1.2.Advantages of our product and suggestions for users
There are three major depression medications on the market today.
Fluoxetine, paroxetine, paroxetine.
Fluoxetine: It can be used for various depression patients, as well as patients with psychiatric disorders such as obsessive-compulsive disorder, but fluoxetine can cause some negative effects of abnormal sleep, abnormal vision or difficulty breathing.
Paroxetine: The effect is fast, but there may be a transition to manic episodes, and rapid discontinuation of paroxetine can lead to adverse reactions.
Venlafaxine: This drug has a quick onset of action and is suitable for patients with depression in various situations. The adverse reactions are often nausea, sexual dysfunction and insomnia. In this way, there is no good drug for depression on the market.
Compared with drugs on the market, our team's gene-edited probiotics can produce 5-HTP and γ-aminobutyric acid (GABA). This section focuses on detailing our role in genetic engineering.
User Instructions
The drug adopts the three-layer coating technology of cyclodextrin. Cyclodextrin is an oligosaccharide composed of amylose, which will not be decomposed by protease in the stomach. The C-H bond on the inside of the cavity renders the inside hydrophobic. All of the above properties can make the drug particles dissolve better in water, and more completely from the digestive tract to the intestinal tract and then cracked. In order to further improve the survival rate and efficacy of probiotics, we have summarized several precautions for use:
1. Use warm water not exceeding 40 degrees to dissolve the drug particles.
The optimal survival temperature for the design of psychoactive probiotics is 37 degrees Celsius, which is to adapt to the temperature in the human gut so that it can better adapt and survive in it. However, if high temperature water is used to brew the medicine, it is likely to cause the death of probiotics. Even though the cyclodextrin coating technology can separate the inner and outer environments, it cannot prevent heat conduction.
2. Use boiled water to brew.
Boiled water is the ideal solution for the drug. Do not use other beverages to brew medicines. Drinks such as milk, carbonated drinks, tea and coffee have different properties. The pH value and content of different beverages may affect the solubility and integrity of the medicine. Especially avoid using tea brewing solutions, because we also inserted a catechin-specific promoter in the probiotics linked to the lytic gene, once the probiotics detect catechin in the gut, the flora will automatically dissolve to release 5-HTP and GABA, but at the same time also caused a lot of bacterial death.
3. The amount of brewing water per pack should be 200ml.
200ml is the most suitable amount of water, because if the amount of water is too small, it will cause adverse results such as drug agglomeration, which will affect the solubility and absorption of drug particles in water. If there is still agglomeration, you can add a certain amount of water to fully dissolve and enhance the activity of probiotics.
4. Not recommended for diabetic patients.
The main component of the coating material used is cyclodextrin, which belongs to sugar, so diabetic patients need to pay attention to sugar intake.
1.3.Market Risk Assessment with solution
1. Consumer might misuse the product, causing side-effect.
After all, our product is a type of drug that will directly affect human body. Once patient misuse our team's gene-edited probiotics, unwanted consequences might take place. To solve this problem, there are detailed guidebook and service number in every single product. consumers need to carefully read those instructions before using drugs.
2. Contamination during production
When we started to product large quantity of gene-edited probiotics, the heavy workload may enable labors to ignore sanitation in factory, which allow our product in low quality. Admittedly, this is a common phenomenon in food production. Thus, to avoid this situation take place, we will assign a manager to walk around the industry, stockroom in every 2 hours to make sure that all products are in high quality. Before release the drugs to market, we will test them again to affirm our products are effective and probiotics are alive.
3. Cashflow suddenly run in short
When corona-virus prevailing, the economy is experiencing a severe recession. It is common that a lot of firms were bankrupt due to government policy and lack of labor. Inevitable, our cashflow may suddenly run in a short, which is a common crisis that every firm may encounter. If that situation happens, we will continue to produce if we are in premise of quality assurance. Our team would rather earn less profit by reducing the quantity of drugs than keep producing them by lower the quality of raw materials. We can make a promise that every single product is in high quality.
Marketing strategy
1. Price
Our consumers will not only be the patients suffering from mild to moderate depression, nausea, loss of appetite, sighing, insomnia and dreaminess, but also for people who have been living in a high-pressure and fast-paced lifestyle for a long time, office workers and students, etc. can use probiotics. Since the range of consumers is wide, our market positioning is medium market, and the price of product won’t be high. Due to our product is probiotics, the costs of producing them is not a few, so we decided to charge a medium price to both prevent the loss and make sure the price is suitable for public general. The company aim to help patients relive from diseases, so the price, about, is in medium range that most consumers can afford it.
2. Product
Our team’s probiotic not only suitable in a wide range of consumers, but also has a little side effect.
3. Place
The main partner we cooperated is hospital, psychological clinic and Pharmacy. Since the medicine is prescribe, so it is easy to sell our products. It can be sold even in store. When patients need drug, they will first think about those places. It is common that pharmacy and supermarket are all round in our environment, such as edifice, school, residence zone, so we take advantages on places.
4. Promotion
In modern society, selling through internet is a wise way. It is common that people are always watching their mobile phone and shopping online, so the first way we can do it sell them through internet. But for drugs, it is better to sell them through doctors. Our team’s probiotics are suitable in a wide range of patients, so it is easy to sell them through recommendation from doctors and even friends. By selling them through our cooperators, we can not only publicize our product, but also save a large expense on advertising and use the money on enhancing our product.
1.4.Future outlook
Nowadays, the competition has become more and more severe, pushing people to work harder even at expense of their health. The situation adds more pressure on people, leading to psychological diseases start prevailing around population. Our team has published a questionnaire about depressions. It turns out that over 30% percent of people have had depression. AMI was predicted to affect 52.9 million persons aged 18 or older in the United States in 2020. This represented 21.0% of all American adults. Females had a higher incidence of AMI (25.8%) than males (15.8%). The prevalence of AMI was higher among young adults aged 18 to 25 (30.6%) compared to those aged 26 to 49 (25.3%) and 50 and older (14.5%). AMI was most prevalent among adults who reported two or more races (35.8%), followed by White persons (22.6%). Asian adults had the lowest incidence of AMI (13.9%). From those data, as the time went by, more people will need those drugs. The pressure and competitions will not stop affecting people.
2.Product's SWOT analysis
Strength：
There are three major depression medications on the market today.
Fluoxetine, paroxetine, paroxetine.
Fluoxetine: It can be used for various depression patients, as well as patients with psychiatric disorders such as obsessive-compulsive disorder, but fluoxetine can cause some negative effects of abnormal sleep, abnormal vision or difficulty breathing.
Paroxetine: The effect is fast, but there may be a transition to manic episodes, and rapid discontinuation of paroxetine can lead to adverse reactions.
Venlafaxine: This drug has a quick onset of action and is suitable for patients with depression in various situations. The adverse reactions are often nausea, sexual dysfunction and insomnia. In this way, there is no good drug for depression on the market.
Compared with drugs on the market, our team's gene-edited probiotics can produce 5-HTP and γ-aminobutyric acid (GABA). This section focuses on detailing our role in genetic engineering. Our consumers will not only be the patients suffering from mild to moderate depression, nausea, loss of appetite, sighing, insomnia and dreaminess, but also for people who have been living in a high-pressure and fast-paced lifestyle for a long time, office workers and students, etc. can use probiotics. Since the range of consumers is wide, our market positioning is medium market, and the price of product won’t be high. Due to our product is probiotics, the costs of producing them is not a few, so we charge a medium price to both prevent the loss and make sure the price is suitable for public general. The company aim to help patients relive from diseases, so the price is in medium range that most consumers can afford it. In modern society, selling through internet is a wise way. It is common that people are always watching their mobile phone and shopping online, so the first way we can do it sell them through internet. But for drugs, it is better to sell them through doctors. Our team’s probiotics are suitable in a wide range of patients, so it is easy to sell them through recommendation from doctors and even friends. By selling them through our cooperators, we can not only publicize our product, but also save a large expense on advertising and use the money on enhancing our product.
Weakness and solution:
1.Consumer might misuse the product, causing side-effect.
After all, our product is a type of drug that will directly affect human body. Once patient misuse our team's gene-edited probiotics, unwanted consequences might take place. To solve this problem, there are detailed guidebook and service number in every single product. consumers need to carefully read those instructions before using drugs.
2.Contamination during production
When we started to product large quantity of gene-edited probiotics, the heavy workload may enable labors to ignore sanitation in factory, which allow our product in low quality. Admittedly, this is a common phenomenon in food production. Thus, to avoid this situation take place, we will assign a manager to walk around the industry, stockroom in every 2 hours to make sure that all products are in high quality. Before release the drugs to market, we will test them again to affirm our products are effective and probiotics are alive.
3.Cashflow suddenly run in short
When corona-virus prevailing, the economy is experiencing a severe recession. It is common that a lot of firms were bankrupt due to government policy and lack of labor. Inevitable, our cashflow may suddenly run in a short, which is a common crisis that every firm may encounter. If that situation happens, we will continue to produce if we are in premise of quality assurance. Our team would rather earn less profit by reducing the quantity of drugs than keep producing them by lower the quality of raw materials. We can make a promise that every single product is in high quality.
4. Not recommended for diabetic patients.
The main component of the coating material used is cyclodextrin, which belongs to sugar, so diabetic patients need to pay attention to sugar intake.
Opportunities:
The main partner we cooperated is hospital, psychological clinic and Pharmacy. Since the medicine is prescribe, so it is easy to sell our products. It can be sold even in store. When patients need drug, they will first think about those places. It is common that pharmacy and supermarket are all round in our environment, such as edifice, school, residence zone, so we take advantages on places. Nowadays, the competition has become more and more severe, pushing people to work harder even at expense of their health. The situation adds more pressure on people, leading to psychological diseases start prevailing around population. Our team has published a questionnaire about depressions. It turns out that over 30% percent of people have had depression. AMI was predicted to affect 52.9 million persons aged 18 or older in the United States in 2020. This represented 21.0% of all American adults. Females had a higher incidence of AMI (25.8%) than males (15.8%). The prevalence of AMI was higher among young adults aged 18 to 25 (30.6%) compared to those aged 26 to 49 (25.3%) and 50 and older (14.5%). AMI was most prevalent among adults who reported two or more races (35.8%), followed by White persons (22.6%). Asian adults had the lowest incidence of AMI (13.9%). From those data, as the time went by, more people will need those drugs. The pressure and competitions will not stop affecting people. The Affordable Care Act of 2010 reflects that government will provide subsidy by using health care system to help those who have mantle disease, so that more people can afford those drugs.
Threats:
1.Public opinions toward GMO
When asked which of three positions best fits their viewpoints, about half of Americans (48%) say the health effects of GM foods are no different than other foods, 39% say GM foods are worse for one’s health and 10% say such foods are better for one’s health. It is true there are different sounds about the safety of GMO foods, and some people also claimed that GMO may cause environmental damaged. But actually, according to data published in 2016 by the National Academy of Sciences, roughly half of the volunteers have heard a little about GMO. And about one-in-five (19%) Americans have heard “nothing at all” about GM foods. Under tis circumstance, we did plenty of works such as moving pictures and cartoon videos to introduce our products and how the medicine works. There are also detailed guidebook and service number in every single product.
2.Government regulations
In the security section of our project, we detailedly introduce the policies of different country related to the use of GMO product. Different countries have different requirements for the sale and safety of GM products, so we checked information about the regulations of GMO in several countries' law to ensure that our product satisfy most of the rules.
Reference：
1. U.S. Department of Health and Human Services. (n.d.). Mental illness. National Institute of Mental Health. Retrieved October 2, 2022, from https://www.nimh.nih.gov/health/statistics/mental-illness
2. https://www.pewresearch.org/science/2016/12/01/public-opinion-about-genetically-modified-foods-and-trust-in-scientists-connected-with-these-foods/
© 2022 - Content on this site is licensed under a Creative Commons Attribution 4.0 International license.
The repository used to create this website is available at gitlab.igem.org/2022/lzu-hs-pro-a.