After coming up with a business plan, our team first interviewd the stakeholder Dr. Wen who is graduated from Nanjing Shifan University and holds a company in the biosynthesis industry. A pitch presentation was held, and questions about the biosynthesis industry were asked. From this interview, we obtained important information and insights about the industry, the development of our company, and the responsibility we biotech companies have to society as a whole.

Figure 1-3: Our business pitch with Dr.Wen

Through the interview, we gained insights into biosynthesis companies about how companies exist as what they are. Dr. Wen suggests a potential business model, highlighting the significance of small biotech companies to be unique and have reliable customers. We learned that some other current biosynthesis companies, such as the Anhui Huaheng, started off by establishing long-term business partnerships with bigger pharmaceutical companies. For small companies like us, it is important to solve existing problems and make a unique impact to fortify our existence in the market. Since our product implements a novel approach to addressing lab leakages, exploiting and developing our uniqueness enhances the value of our company. Our unique address to the real-world issue of bio-leakages and intellectual properties articulates our mission to control and limit pollution. We also learned insights in the pricing of plasmid-related products; the price of similar plasmid-related products are set to be around ¥1,500.

The interview also articulates the responsibilities we bio companies must take. As biotechnologies become cheaper and cheaper, more people, especially people who are less conscious about biosafety, have gained access to biotechnologies. Dr. Wen made a simple juxtaposition to illustrate the danger of this phenomenon. He exemplified the Covid19 pandemic: the genome of the Sars-CoV-2 virus could be made with no more than 6,000 dollars. Because potential destruction could be done at a relatively cheap price, preventing leakages has become a social responsibility that all bio companies must take.

Our team has completed an formal business plan after the interview and further research, and it is presenting below.

Executive Summary

Laboratories and factories are notorious for releasing dissemination of microorganisms like Escherichia coli into the surrounding environment. E. coli, a type of bacteria that inhabits in the intestines of warm-blooded animals. Their appearance in environments like lakes and ponds upsets the ecological balance of the ecosystem. Furthermore, bacterial infiltration of the environment impacts human health. Humans may consume ingest contaminated water or crops and fell sick to these unnatural, lab-released bacteria. In light of the dire situation and the associated risks, our team decided to develop an innovative technology aimed at mitigating the dissemination of E. coli into the surrounding ecosystem.. We plan to install a temperature-responsive kill switch in E. coli so that upon transitioning from lab temperature (37) into natural temperature (22), the engineered system will trigger the production of toxins to kill the E. coli. It will be packed and sold in a test kit. The implementation of this kill switch requires a cost-effective, ensures high effectiveness, and advances gene recombinant technology. Additionally, it not only safeguards the environment against the harmful effects of bacterial waste, but it also protects laboratories from theft. You can't really steal a corpse.

Market Analysis

Our company operates strategically in two critical fields: bio-safety and synthetic biology. In the bio-safety sector, our primary focus is on ensuring the safe handling, containment, and management of biological materials, including bacteria and viruses. Emerging technologies in this field, such as biofuels, have the potential to pose severe environmental risks. We are dedicated to developing innovative solutions to prevent accidental releases of laboratory materials. This not only protects the environment but also secures the work of scientists.

The global biological safety cabinets market has shown significant growth, exceeding $170 million USD by the year 2020 and projected to reach $282 million USD by 2027, with an estimated compound annual growth rate (CAGR) of approximately 7.5% from 2020 to 2027. Additionally, the local Chinese market exhibits promise, especially with policies like "13th Five-year Plan for the Development of the Pharmaceuticals Industry" and “14th Five-year Plan for the Development of the Pharmaceuticals Industry" providing substantial support for biology-related fields and play a crucial role in guaranteeing safety and promoting adherence to established standards, as reported by National Statistics (2023).

In the field of synthetic biology, exciting advances are reshaping the market and industry. Globally, the synthetic biology market reached $13 billion USD by 2022, with an impressive CAGR of 18.97%. China's synthetic biology sector is equally impressive, achieving $9.3 billion USD, constituting a substantial 3~4% of the GDP, driven by a projected 8.5% CAGR. The continuous emergence of new technologies and discoveries is revolutionizing both fields, unlocking greater efficiencies and vast potential for future advancements (Naitonal Statistics, 2023).

After analyzing market size, it's crucial to consider the status of the involved fields. In both industries, these sectors demand advanced expertise and cutting-edge technology, resulting in high entry barriers. Regulatory guidelines such as "The Republic Of China Environmental Protection Law" and the "14th Five-year Plan for the Development of the Pharmaceuticals Industry" ensure safety and compliance. Challenges for new entrants enrich the environment's potential, intensified by intense competition across various price points and quality levels.

Despite challenges, sector diversity and the demand for innovation drive the development of new products, influencing fluid market dynamics. Government support through policies strengthens prominence and competition. Customers play a significant role due to alternatives, and their feedback, stemming from a substantial laboratory customer base, fuels product evolution.

Our pioneering products can refine laboratory protocols, even in the face of skepticism about traditional methods. Our innovative kill switch approach revolutionizes prototype leakage prevention protocols. Suppliers' limited influence is balanced by broad material availability. Furthermore, our products play a role in raising awareness and addressing concerns related to bacterial leakage and environmental pollution, setting new standards for safety and sustainability in the industry.

Competitive Analysis

Traditional methods in preventing bacterial leakage encompass sodium hypochlorite disinfection, chlorine disinfection, and UV light disinfection. In contrast to our genetically modified kill switch that activates on its own, these devices necessitate human oversight and control. Human management is susceptible to errors which consequently diminishes the method's efficacy. Low efficacy is associated with higher chances of lab leakage, which is not only harmful to the ecosystem but also detrimental to the lab's reputation. Moreover, the utilization of human labor requires more time and cost, making it less efficient in terms of generating revenue. These traditional methods employed by our company’s competitors in terms of our parallel goals. Nevertheless, they can serve as a compliment as well, since they do not use comparable innovative kill switch technologies as our product.

Currently available gene recombinant prevention techniques, such as the "Passcode" kill stwitch, "Deadman" kill switch, and the traditional metabolic auxotrophy strains, depend on the presence/absence of unnatural chemicals or extensive engineering. Relying on unnatural chemicals increases production cost and diminishes the switch's effectiveness. For kill switches that require the presence of specific synthetic substances, the range in which it can function is predominantly constrained as unnatural chemicals are rarely available in natural settings. For those that rely on a substance's absence, it is common for the unnatural chemicals to leak alongside the E. coli for they are handled together. These systems are also vulnerable to bacteria cross feeding, making it less desirable in laboratory environments. Extensive engineering required for alternatives like the metabolic auxotrophy strain will drastically increase the cost to meet the demand for production. Our product, however, functions without these stringent prerequisites, giving it a comparative advantage in terms of efficacy and affordability. Our product relies on temperature change, a natural phenomenon of temperature change, rather than unnatural chemicals to function. Hence, our product is able to minimize side-effects while disregard the cost of manufacturing supplementary chemicals. Moreover, our product can be mass-produced at a low cost due to the plasmid's ability to reproduce in tandem with the host cells.

In addition to the notable strengths mentioned above, our product's strength lies in its target specific nature and considerable potential. Alertness towards the release of genetically modified organisms into natural environments remains high for fear that it might induce unintended alterations in the ecosystem. In this particular scenario, the kill switch is inserted into the E.coli, meaning it's effects are contained within the bacteria. Consequently, this design ensures specificity, preventing any adverse effects on the surrounding ecosystem. Furthermore, the E. coli-oriented switch serves as only a prototype for our future developments. E. cooli plans to extend its project and work towards installing the kill switch in other bacterial strains that may possess a higher degree of lethality or prevalence in terms of potential leakage. The development of our project is expected to attract more customers leading to boosting revenue and promising growth.

Despite the numerous strengths our kill switch demonstrates, it possesses several weaknesses. The switch is only activated at the specific temperature of 22 degrees Celsius. This temperature is approximately the average temperature seen in natural water bodies. It does not take factors like climate zones and seasons into consideration, which ultimately abates the versatility of our product. Moreover, even within controlled laboratory settings, E.coli cannot be left out at unregulated temperatures (not 37), making experiments less convenient. Another weakness of our product pertains to the potential for mutation. Our product's low cost comes at the expense of mutations, which result from replication of E. coli and the plasmid within them. Mutations may mutilate the kill switch's abilities, but its extent can only be fairly evaluated after the lab team compete their experiment.

The economic, social, and political environments provide E.cooli with opportunities to grow and prosper. The biotech industry Ecooli operates within a sector that is currently undergoing significant expansion. From a global perspective, the industry is expected to have compound annual growth rate of 14.2% over the course of the next seven years. In Chinese market, the industry anticipates a CAGR of 8.8% throughout the upcoming biennial period. The promptly developing industry suggests a large market, which supports E.cooli's entrance by providing sufficient quantities of demand. Social awareness towards biosafety topics and environmental health has been growing substantially as well. According to a recent study conducted by Hindawi (2023), there has been a consistent upward trend in the number of posts related to environmental concerns on the Chinese social media platform Weibo. Moreover, 66% of the posts fixate on finding a solution, whether it be through economic or political measures. These data indicate the extent to which the public's recognition of the issue and their expressed commitment to find a plausible solution. E.cooli's objective, which centres around mitigating biochemical leaks to safeguard the environment, is congruent with the interests of the general people. Thus, the current social environment is conducive to the expansion and advancement of our company.

The political sphere exhibits similarities to the social sphere. The government encourages biotech developments and biosafety projects. Government officials hosted an official lecture centered on "Biosafety laws" and "Microbial lab biosafety laws", expressing their endorsement for biosafety including projects like.

Even in a highly supportive environment, E.cooli still encounters many threats that may impede the company's growth. In such rapid growing industries, the presence of formidable competitors is to be expected. The emergence of novel technologies with similar functions as ours will augment rivalry and diminish our prospects of acquiring market dominance. In fact, Pamela Silver and James Collin (2023) has already developed a temperature dependent kill switch for E. Coli. Although the logistics are different from ours, their kill switch would be a noticeable competitor if they decide to launch the. Moreover, Tae Seok of washington university recieved $744,000 grant for his microbial 'kill switch' research. His kill switch is designed to selectively target a wide range of bacteria. Given the substantial funding allocated to his research, there is a decent possibility that he may succeed and outcompete us with his switch's broadness of application.

Strategy Formation

Product

Our product prevents unwanted contamination by providing E. coli the ability to normally function at around 37 degrees Celsius, while to initiate self-destruct at around 22 degrees Celsius. The temperature control is facilitated possible via the Lux/Luxi quorum sensing system. Using this system, transcription of ocdB genes is predominantly restricted at 37 degrees Celsius, whereas transcription of the genes at 22 degrees Celsius is permissible. By transforming our product into E coli, bacteria will become unable to survive at temperatures near 22 degrees Celsius.

Promotion

The commencement of our promotional campaign is scheduled for August 8th, during which we will conduct educational activities aimed at enhancing public understanding and consciousness of biosafety.

Our company will promote our products through eight distinct strategies We are going to disseminate our scientific journals on "Science Direct", while spreading our product/principle through news articles on "People's Daily". Meanwhile, we will be focusing on specific groups that use E. Coli directly by means of email. Discounted packages for large online orders (specific discounts to be determined) will be made available on our website, "E. Cooli (website link)". We plan to spread awareness on bio-safety via many platforms, including our WeChat official account, Xiaohongshu(a popular social media platform similar to Pinterest), bilibili (similar to YouTube), YouTube, and offline classes, to effectively disseminate information and raise awareness about bio-safety, which is scheduled to start on August 8th. In addition, we intend to buy Google AdWords for the keywords including "biosafety", "E. Coli", "leakage", and "kill-switch", targeting people in specific fields. Last but not least, we will attend bioengineering and synthetic biology seminars, such as ACBD-ISBM and International Bio-fermentation Products/Tech Equipments Expo. As mentioned above, E. Cooli can also inform customers of our updates and new launches.

Place

The primary distribution of our products is our website "E. Cool-i". Our headlabs are located in China, Suzhou, a high-tech district, an area concentrated with science and technology-related companies. Our monthly cost of lab and labor fees is about ¥75,000, providing a relatively low cost compared to that of Shanghai. Suzhou has an abundant amount of potential employees, with lower costs in human resources as well. Furthermore, the short distance to major transportation centers helps reduce the costs of delivery.

Cost Evaluation

The startup cost of our product constitutes of mostly lab rent, procurement of laboratory equipment, and labor costs. Among these costs, the acquisition of lab equipment could be bought in single transaction, while lab rent and labor costs necessitate monthly payments.

To balance lab rent and product delivery costs, simultaneously maximizing access to educated employees, we plan to set up our lab in Suzhou. Suzhou is geographically close to Shanghai, with similar degrees of development but substantially cheaper rents. Production of our product demands college-level education. The estimated monthly of college-degree employees working in biotech companies in Suzhou ranges from ¥10,000 to ¥15,000 per month, so our estimation uses the middle value of ¥13,000. In general, our monthly cost is around ~¥75,000.

The major lab equipment comprises refrigerators, bacteria incubators, and clean benches. The refrigerator should be capable of attaining r a temperature of 20 degrees Celsius to preserve our product. In order to meet the operational needs of our laboratory, it is necessary to have a minimum of one fridge, one bacteria incubator, and multiple clean benches being contingent upon the number of staffs. Other lab apparatus is also required but only makes up a trivial proportion of the cost, thus being omitted in our calculations. To start our production, E. coli DB3.1 and various DNA strands must be bought with which collectively amount around ¥3,000. The cost of building our website is estimated to be around ¥10,000. The overall expenditure for equipment is around ¥97,000.

The aggregate startup cost amounts to ¥547,000, constituting the cost of the equipment and monthly cost counting up until the 6th month. The specifics of the startup cocst are presented in the list below:

Table 1. Above is the calculation of the monthly cost, and below is to be paid at once.

The unit cost of our product constitutes primarily of pipette heads (of two different types), packaging, bacteria culture tubes, centrifuge tubes, and delivery fee. Our product is packaged in paper boxes. It is worth noting that ideally, engineered bacteria could be reserved at low temperatures for extended years, resulting in a negligible cost for the plasmid.

Delivery fee makes up most of the unit cost, as our product demands to be delivered below freezing conditions. The Shunfeng Express is accompanied with a substantial cost. As a reference, the delivery fee from Suzhou to Guangdong City is at least ¥500. Nonetheless, the determination of whether or not customers are paying the delivery fee remains undecided.

Unit cost is estimated in the table below. The actual unit cost is likely to be lower than the estimation provided in the table, as actual production is likely to be conducted on greater scales.

Table 2. The estimated unit price of our product. The price of each item comes from internet data.

Estimated Price

To accurately estimate the price of our product, we consider the following factors:

1) profit rate;

2) the pricing of similar products;

3) market size and market trend.

The profitability of our product, on its own, remains an infeasible indicator to price estimation due to the vulnerability of our product to replication: customers could easily replicate our product once buying it the first time. However, the profit rate provides valuable insights into pricing particularly when considering the potential risk associated with clients making a one-time purchase of the product. The price of our product should not be significantly cheaper than the price of constructing DNA plasmids from the sequence data only. Currently, the market price for constructing DNA plasmids from sequence data is around 0.8¥ per base pair (Twist, Doulix), while the length of the reporter gene we use is approximately 3,000 base pairs long. Thus, the price of our product remains within the range of ¥2,400, without deviating significantly below or below this threshold.

The market price for plasmid products ranges from above ¥2,000 (Merck) to around ¥600 (AddGene), depending on the public demand for the plasmid (¥600 for the plasmid containing the commonly used GFP gene). This range agrees with the ¥2,400 threshold mentioned above. Considering the lack of competing products and the relatively scarce demand (as compared to GFP genes), the price of our product would be positioned towards the upper echelon of the spectrum.

The growth of the recombinant DNA market and the bioengineering market in the last decade also supports a higher price. Combining aforementioned factors, the reasonable price for our product is deduced to be ¥1,500 in the near future.

Production Quantity Revenue

The estimation of revenue is contingent upon the market growth rate. In 2023, the synthetic biology market in Asia-Pacific is estimated to be worth USD 1.48 billion, projected to grow at a compound annual growth rate (CAGR) of 26.8% between 2023 and 2028.

The objective of our company is to reach a market share of 0.5% in the initial year, with a long-term goal of attaining 3% of the market share eventually in synthetic biology market.

Legal Ethics:

In the realm of rapid scientific progress, our company stands as a beacon of innovation and safety, addressing a pivotal challenge within laboratories. Our unwavering focus on research integrity and environmental responsibility places us at the forefront of pioneering a solution to prevent bacteria leakage in lab environments. This section underscores our commitment to legal compliance and ethical stewardship, where cutting-edge science intersects with ethical imperatives.

Legal Considerations:

Our dedication to legal compliance is paramount as we introduce our groundbreaking plasmid products designed to prevent bacteria leakage. Adherence to the GB/T40170-2021 standard forms the cornerstone of our approach, guiding plasmid product regulations comprehensively. This standard encompasses critical elements such as extraction kits, operational procedures, and maintenance, ensuring alignment with established guidelines. Notably, the GB/T40170-2021 standard provides a comprehensive guide to plasmid detection methods and indicators, prioritizing accuracy and reliability in our product results.

Moving forward, our team is steadfast in adhering to the provisions outlined in GB/T40170-2021. This commitment ensures that our products contribute to a laboratory environment that's both scientifically progressive and ethically responsible.

Environmental and Social Responsibility:

Our plasmid product goes beyond scientific advancement; it embodies our commitment to environmental preservation and societal well-being. By preventing bacteria leakage, we actively contribute to ecological protection and heightened laboratory safety. Our sustainable manufacturing practices and ethical partnerships underscore our dedication to minimizing our impact and fostering fairness in every facet of our operations. Our innovation extends beyond progress—it's progress rooted in respect for our planet and empowerment of our communities.

United Nations Sustainable Development Goals (SDGs): 17 objectives established by the United Nations to address global challenges and promote sustainable development. Our company's efforts resonate with several United Nations Sustainable Development Goals, linking our mission to broader global aspirations. Specifically, our commitment aligns with:

- Goal 9: Industry, Innovation, and Infrastructure: Our innovative plasmid solution contributes to advancing laboratory safety infrastructure and aligns with the goal of fostering innovation for sustainable industrial growth.

- Goal 12: Responsible Consumption and Production: By implementing sustainable manufacturing practices and minimizing our ecological footprint, we align with the goal of promoting responsible production and consumption patterns.

- Goal 15: Life on Land: Our dedication to preventing bacteria leakage has a direct impact on safeguarding terrestrial ecosystems and supporting the goal of protecting and restoring biodiversity on land.

-Goal 17: Partnerships for the Goals:Through ethical collaborations and partnerships, we align with the goal of fostering partnerships that bring together various stakeholders to work collectively towards shared sustainability objectives.

By addressing the challenges of bacteria leakage and emphasizing the need of environmental responsibility, we contribute to a world where science thrives hand in hand with sustainable practices, making meaningful strides towards a more promising future for humanity as a whole.

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