Entrepreneurship

Overview

Entrepreneurship is crucial for product development and expansion. To ensure that our product, a bioreactor with genetically modified cyanobacteria designed to enhance the efficiency of its natural carbon fixation mechanism, can compete with other technologies in our target market, our team analyzed the product’s market potential and potential future directions.

Since our goal is to reduce CO₂ emissions, we aim to implement our product in energy sectors and power plants. To compete with existing products in the current market, we need to identify our target customers and current competitors. To sum up, these are some key aims for our entrepreneurship proposal:

1. Identify our goal, as well as target customers
2. Form a competitive market analysis regarding our product against other competitors
3. Calculate total spending along with the financials and funding
4. Formulate short and long-term business plans for marketing management

Centering on these four points, we developed a business plan that positions our product as a distinct advantage in the market, enabling us to compete effectively against existing technologies. In the long term, we plan to expand our business into international markets to maximize its global impact.

Goal & Market Focus

Greenhouse gas (GHG) emissions released across a company’s entire supply chain are assessed under a scope system ranging from 1 to 3. Scope 1 refers to emissions generated directly by company operations, including plants, facilities, warehouses, or offices (Global Climate Initiatives). Based on global emission reports, energy sectors contribute approximately 75.7% of global greenhouse gas emissions annually (EPA, 2024). As shown in Figure 1, the broad energy sector is composed of industries. Moreover, the energy sector contributes to approximately 90% of the total air pollution emitted in Taiwan (FFTC, 2024). Therefore, we must target the energy industry as it has a greater impact on the environment. Although existing technologies, such as solvent absorption and solid absorption technologies, as well as microalgae, are available to consume the emitted carbon dioxide, they are relatively expensive and ineffective. Specifically, in Taiwan, solvation absorption technologies cost $40 to $60 per tonne of CO₂ absorbed and absorb 40 million tonnes per year (Taipower). Considering that global CO₂ emissions amount to around 37.41 billion tonnes (Tiseo, 2025), the technology lacks industry-scale efficiency, as it only contributes to approximately 0.07% of the total emission absorption. Therefore, it is essential to develop effective and efficient technologies that have a practical impact on reducing CO₂ emissions.

1. Target Customer Profile
   Based on technical constraints of our photobioreactor, specifically the necessity of a pre-purified CO₂ source and our incentives regarding global ESG alignment, the target market is narrowed down to CO₂ emitters categorized under Scope 1 direct emissions, with over 25,000 tonnes of CO₂ emissions equivalent (tCO₂e) and with existing detoxification infrastructure to deliver a purified CO₂ stream.
   1. Scope 1 and mandated volume: The customer must have direct emissions released from sources owned or controlled by the customer (Scope 1), primarily in on-site power generation and heavy manufacturing. These entities are subject to Taiwan’s mandatory carbon fee system, which applies to businesses emitting over 25,000 tons of CO₂ annually.
   2. Infrastructure maturity: The primary constraint of the bioreactor is the inability of living cyanobacteria to tolerate raw, dirty flue gas, which requires targeting industrial partners who already operate gas purification or scrubbing systems. This reduces the risks to the cyanobacteria, which are the core component of the carbon-fixing ability in the photobioreactor.
   3. International ESG and compliance pressures: Companies with international customers are pressured to meet global ESG standards for competitive advantages in the worldwide market
2. Taiwan’s Regulatory Environment
   1. In 2026, the Ministry of Environment announced that Taiwan would formally collect carbon fees based on companies’ 2025 emissions, following a year of reporting carbon emissions in preparation for the carbon fee requirement. The standard carbon fee rate is set at around $10 USD per tCO₂e (Ministry of Environment, 2024). This fee system targets major emitters of 25,000 metric tons of CO₂e annually, while simultaneously promoting voluntary accelerated reductions at a lower price per ton of CO₂e. Companies that achieve specific technical benchmarks by adopting technological solutions, known as Preferential Rate B, can qualify for a discounted rate of approximately $3.28 USD per tCO₂e (Climate Change Administration, 2025).
   2. By 2030, companies will face escalating carbon fee rates, ranging from $39.43 USD to $49.28 USD per tCO₂e, in alignment with international carbon pricing (Climate Change Administration, 2025). With the 2025 emissions reporting already in effect, major industrial emitters must begin implementing carbon reduction solutions immediately to qualify for preferential rates when fee collection begins in 2026. These emerging regulatory frameworks position our technology for market entry at a critical decision-making window where emitters are actively seeking proven technological solutions. By establishing partnerships with early adopters, we can become the benchmark solution for achieving Preferential B status, thus influencing industry standards for biological carbon capture and securing market leadership before competition intensifies.

Solution Overview

Our team developed a carbon fixation chamber device using cyanobacteria to help mitigate carbon dioxide emissions. We plan to have our device installed in industries clearly defined as Scope 1 (direct) CO₂ emitters, which contain purification systems to which our product can be attached. By applying genomic engineering to the cmpABCD operon in the cyanobacterial strain S. elongatus PCC 7942, we aim to improve the BCT1 bicarbonate transporter’s expression, allowing the assembly of more HCO₃^- ions into the carboxysome, and thus enhancing cyanobacterial carbon fixation efficiency. Ultimately, we aim to provide a competitive alternative to existing technologies and solutions through our project design.

Our product will be attached to a conditioned flue-gas slipstream downstream of the existing control systems. Figure 1 presents an illustration of our product, while Figure 2 showcases the production process, from the initial stage of choosing the plasmid’s part to the concluding phase of business integration.

Fig 1. Diagram of the Carbon Fixation Chamber Device

Fig 2. Phases of the Production Cycle

Market Validation

Survey for iHP

To assess the feasibility of our photobioreactor among buyers, a targeted survey was conducted with individuals familiar with industrial sustainability practices, renewable energy solutions, or climate-focused research and development. Industrial stakeholders acknowledged that existing mitigation reduction options, such as carbon credit purchasing or post-combustion scrubbing, were cost-intensive with limited economic return beyond regulatory compliance. Their responses revealed that carbon reduction is widely viewed as a financial and operational burden, particularly given the high cost of large-scale carbon scrubbers, which are also challenging to integrate into existing infrastructure. There is also difficulty creating incentives for carbon reduction technology without government pressure or mandatory carbon reduction measures, such as in Taiwan, where carbon tax systems are underdeveloped (European Chamber of Commerce Taiwan, 2024). According to our survey, respondents viewed enhanced cyanobacteria as a credible solution due to their containment and genetic stability. The respondents’ interest in passive, low-maintenance technology was high. Still, they also indicated that adoption would depend on quantified CO₂ reduction per unit volume, cost per ton of CO₂ fixed, and compatibility with existing Environmental, Social, Governance (ESG) reporting protocols. The survey feedback suggests that our primary competitor is institutional reluctance toward high-cost carbon solutions with unclear returns on investment. Therefore, successful market entry hinges on positioning around operational simplicity and quantified and standardized performance metrics.

Market Size

Fig 3. Market Potential TAM SAM SOM Diagram

Considering our product scale and potential impact (as specified in the business plan), we have predicted market sizes, as shown in the figure to the right. Specifically, our predicted business markets are categorized into SOM, SAM, and TAM.

1. The Total Addressable Market (TAM) represents the maximum revenue opportunity for a product, assuming it achieves a 100% market share without competition. For our product, we predict that we will be able to expand our market size to the global power plant market with a total market size of $125 billion USD with over 25,000 power industries, and without competition from current technologies, due to the significance of our product to contemporary society (IEA, 2025).
2. Serviceable Available Market (SAM) refers to the total market that a business can reach with its current business model and operational capabilities. Based on our business model, with approximately 15,000 power enterprises, we will be able to expand our business into the Asian industrial market, which has a total market size of $60 billion USD (IEA, 2025). We believe that the entire Asian market can represent the actionable portion of TAM since many countries in Asia, such as China, heavily value carbon trading and are motivated to reduce emissions and maintain a competitive advantage. Therefore, the Asian power industry will be our achievable market within TAM.
3. Serviceable Obtainable Market (SOM) realistically models our potential market size. Since our product is in its startup phase, it’ll benefit us the most if we start within Taiwan, allowing us to stabilize our implementation procedures. With over 500 power industries, the total market size of the power industry is $75 million USD (Cai, 2023). Although Taiwan does not rely on carbon trading systems as heavily as international power industries, it has launched international carbon credit trading systems and is confirmed to introduce a mandatory Emission Trading System (ETS) by 2026 (TCX, 2026). In addition, 500 enterprises in Taiwan were charged for emitting over 25,000 metric tons of CO₂ in 2022 (Ministry of Environment, 2022). Therefore, it is expected that the ETS market will grow rapidly in the coming years, and our product can bring substantial benefits to the power industry.

Fig 4. SOM of enterprises in Taiwan subject to mandatory carbon fees

At this stage, we’re targeting SOM and hope to reach out to 5-15 companies. With this model, we can anticipate our future markets and goals, charting a clear path for our business.

Business Model

We chose to utilize the Business-to-Business (B2B) model to maximize our marketing efficiency and effectiveness. B2B is a business model where transactions are exchanged between two companies, rather than directly selling to individual customers (Schepizi, 2024). B2B generates two main benefits for us: adequate finance and strong customer management.

1. Finance
   B2B often involves long-term contracts that require a large upfront payment and secure long-term income, boosting overall cash flow and stabilizing revenue. For our product, targeting industries identified as Scope 1 CO₂ emitters allows us to utilize a B2B model, which opens up possibilities for making bulk sales contracts rather than individual customer purchases. This establishes a predictable revenue stream, increasing business stability. For customer businesses, our product also reduces their spending costs, as it is more expensive to build a large-scale mechanical carbon capture system. Additionally, our product operates efficiently while maintaining low costs, resulting in a high cost-performance ratio. By limiting carbon emissions, our customers can earn carbon credits and sell them to other industries for profit.
2. Customer Management
   Incorporating B2B also reduces variability within the customers, as it requires one to appeal to another business instead of millions of customers. This enhances marketing efficiency since the customer size and variability decrease, strengthening customization for individual industries. With deeper customization, we can tailor our product specifications to each company’s unique conditions, fostering trust and loyalty, and enhancing our competitive value. In addition, since B2B relationships often propose long-term contracts, we become a partner rather than a supplier in sustainability maintenance, increasing our value in the marketplace.
3. Hybrid Sale-Service Model
   Our business model was informed by an interview with a medium-sized factory owner Mr. Lou, who informed us that ESG benefits were not sufficient as an incentive toward carbon reduction, inspired us to consider repurposing the biomass byproduct into a profitable product. We integrate a secondary revenue stream by valorizing cyanobacterial biomass produced in the bioreactor. Instead of treating the accumulated biomass as waste, it is harvested, purified, and processed into a high-value aquafeed supplement for shrimp. Clients benefit from both direct carbon emission reductions and additional revenue from byproduct utilization. At the same time, we secure recurring income streams beyond the initial device sales, solidifying long-term collaboration by bridging sustainability goals with economic value.
   1. Device sales: The device will be sold directly to industrial clients, who will own and operate it as part of their carbon reduction infrastructure. Rather than requiring the client to manage the cyanobacterial cultures, we will provide an ongoing service partnership. Once the culture in the photobioreactor reaches its optimal optical density, the cell growth rate and carbon fixation efficiency will decline, signaling the need to replace the medium. To maintain continuous, efficient operation, a monthly service is offered during which we harvest accumulated biomass and refill the reactor with fresh liquid culture, ensuring peak fixation performance without additional work for the client.
   2. Biomass revenue: Under a revenue-sharing agreement, we collect and process the cyanobacterial biomass produced by the client’s installed photobioreactor. In return for providing monthly culture replacement and downstream processing services, our company retains 40% of the total revenue generated from biomass sales. In comparison, the client receives 60% of the volume of biomass generated at their facility, proportional to the volume. On average, the system produces 66.97 kg of biomass per month, generating $7,036.94 USD in revenue for our company and $10,555.42 USD for the client, at a market value of $21.89/kg.

Key Metrics

To ensure our solution delivers measurable climate and economic impact, success indicators are defined using metrics that directly link CO₂ reduction, financial viability, and biomass recycling (Sustainability Directory, 2025). Each metric was selected to reflect a quantifiable relationship between the problem of carbon emissions and our proposed bioreactor, which produces harvestable biomass.

Competitive Assessment and Differentiation

Our genetically enhanced cyanobacteria and business model are key to our value proposition and competitive advantages against bio-based carbon fixation technology, mainly by linking synthetic biology to essential compliance and ESG objectives.

Fig 5. SWOT analysis diagram

As shown in Figure 3, our SWOT analysis has identified how our photobioreactor presents a competitive advantage against both conventional mechanical carbon fixation systems and bio-based solutions.

1. Advantage over mechanical carbon fixation systems
   Unlike direct air capture or chemical scrubbers, which rely on high heat and pressure, our photobioreactor utilizes cyanobacteria’s innate carbon concentrating mechanism for passive CO₂ fixation (Li et al., 2016). By capitalizing on natural biological function, operating and energy costs are significantly reduced.
2. Advantage over bio-based carbon fixation solutions
   Our chosen cyanobacterial strain, Synechococcus elongatus PCC 7492, is one of the most widely studied cyanobacterial strains, which reduces high biological variability often found in wild-type strains (Adomako et al., 2022). The key enhancement is optimization for higher carbon uptake, allowing our cyanobacteria to better saturate the RuBisCO enzyme with substrate, thereby driving higher fixation rates. The closed system of our photobioreactor also provides reliable opportunities for scaling up, unlike open-pond solutions that face issues such as poor CO₂ transfer, contamination, temperature sensitivity, or fluctuating performance depending on environmental conditions (Nguyen, 2023).

Competitive Assessment

To ensure that our product has a high market value in a highly competitive environment, we researched existing technologies, including their scope, carbon fixation efficiency, and sustainability. Although most carbon-fixing efficiency data were kept confidential, we came across Formosa Smart Energy’s “Flue Gas CO₂ Capturing and Utilization Technology R&D Project”. We conducted a competitive analysis of our product and their proposal.

Formosa Smart Energy
Formosa Smart Energy Tech Corp. (FSET) is one of Taiwan’s largest battery cell plants, producing battery cells, energy storage systems, and renewable energy systems. With multiple sustainability technologies, FSET also presents a “Flue Gas CO₂ Capturing and Utilization Technology R&D Project” in 2020, aiming to capture CO₂ using microalgae in flue gas and convert it to alkanes. The site was officially launched in 2022 and has reduced around 100 thousand tons of CO₂ every year since then. By recycling CO₂ and selling it to downstream companies, the project ensures sustainable development throughout the process (Formosa Plastics Corporation). Their project was selected as one of the 100 most technologically significant new products of 2020 by R&D Awards and was subsequently identified as one of Taiwan’s most impactful carbon fixation technologies (Formosa Plastics Corporation, 2020).

Efficiency Comparison
After meeting with Dr. Chu, we were advised to include a competitive analysis with existing bioreactor technology to assess our market position and relevance. According to our modeling results, our photobioreactor fixes 8.0309 tons of CO₂ per year per liter. On the other hand, according to Formosa Plastics Group, its flue gas technology captures 100,000 tons of CO₂ per year, and each kilogram of microalgae consumes up to 2 kilograms of CO₂ (Formosa Plastics Corporation). For an accurate comparison of carbon fixation rates, the units must be standardized to a common baseline of CO₂ per year per liter. The calculations are shown below:

Firstly, since 1 ton = 1,000 kg,

100,000 tons CO₂ / year = 1,000 kg / ton = 100,000,000 kg CO₂ / year

Next, to determine how much microalgae is needed, we need to divide the CO₂ absorbed by 2, as 1 kg of microalgae absorbs 2 kg of CO₂:

100,000,000 kg of CO₂ 2 kg of CO₂ kg of microalgae = 50,000,000 kg of microalgae

To find the number of tons of CO₂ absorbed per kg of microalgae per year, we divide the tons of CO₂ captured per year over the mass of microalgae needed:

And since 1 kilogram is approximately equal to 1 liter, Formosa Plastics Group’s flue gas system captures 0.002 tons of CO₂ per liter of microalgae per year.

Comparing the two technologies, our technology captures 8.0289 more tons of CO₂ per liter per year compared to the flue gas system, indicating that our technology is 8 times more efficient than the existing technology. This places us at an advantage in the SOM market, knowing that FSET’s flue gas technology is already approved by international awards and efficient in the Taiwan power industry.

The main incentive for companies to adopt CO₂ reduction solutions is the support in achieving ESG benefits and carbon tax savings.

1. Preferential carbon fee rates: Under Taiwan’s 2026 carbon fee system, major emitters must demonstrate quantifiable numbers, which can be collected by the CO₂ sensor attached to our photobioreactor, and submit voluntary reduction plans to qualify for discounted carbon fee rates. For facilities at the annual 25,000 tons CO₂ minimum mandatory threshold, with just one unit, our photobioreactor can capture around 400 tons of CO₂ which qualifies for Preferential Rate B, cutting carbon fees by around 68% from $250,000 to $80,683 with total savings of $169,317 annually.

   	Annual CO2 Emissions (tons)	Annual Carbon Tax (USD)	Annual savings (USD)
   Without photobioreactor	25,000	$250,000	0
   With photobioreactor installed	24,599	$80,683	$169,317

2. Global competitiveness: Taiwan’s strategic move with the European Energy Exchange signals clear goals to adopt emissions-trading systems, which will enhance the long-term value of carbon credits and solidify incentives for passive, low-cost carbon-fixation solutions. The carbon tax will decrease significantly, as shown in the table, by 2030. With our technology, it will be reduced to a lower number. For instance, the European Union Emissions Trading System (EU ETS) projects the carbon trading prices to reach ​​around $172.51 USD per ton by 2030. This benchmark highlights how much economic value carbon credit holds in the upcoming years and how adopting similar mechanisms in Taiwan can be economically beneficial. Considering one unit of our photobioreactor, a company with 25,000 tons of CO₂ emissions can profit $69,004 in carbon trading credits from reducing 400 tons of emissions.

In terms of business model, contributing to a circular economy by creating a secondary revenue stream from biomass byproducts provides a financial safety net against high-cost CO₂ capture and sequestration (CCS) competitors. By positioning the residual biomass as a profitable wholesale ingredient, customers can capture the high-value market that helps offset their costs. Our approach secures our value proposition by ensuring our solution generates value from both the primary carbon fixation and the biomass byproduct.

Profit and Cost Calculations

Since it is crucial to estimate the profit that will be produced, we first calculated the fixed and variable costs (VC) that we need to consider. The following tables show a list of materials and prices, including not only materials used for product building but also resources needed during installation and recycling processes:

Table 1. Fixed Costs of Our Product

Table 2. Variable Costs of Our Product Materials (in units per kilogram))

Table 3. Variable Costs of Our Product Materials (in units per base pair and quantity unit)

Table 4. Variable Costs of Our Product Materials (in units per liter and worker)

The equation for our company’s profit calculations goes:

Profit = Revenue - (Total Variable Cost + Total Fixed Cost)

For our product, it is challenging to estimate the Total Variable Cost (TVC) since our materials are measured in various units, including kilograms, base pairs, and liters. If we were to calculate the TVC, we would need to know the exact quantities of all the materials required to sum up the costs of materials with different quantity units. Therefore, while we’re unable to estimate our TVC precisely, we came up with an equation for that.

TVC = VC per unit a × total number of units a+VC per unit b × total number of units b…

In this equation, a and b represent different quantity units (e.g., kilograms, liters, base pairs). With the formula, we can directly calculate the total number of units needed for other materials, customized to meet the specific needs of various companies.

Revenue=(product price × number of products) + (supplement's price × 40%)

The equation shown above is a model for our revenue calculations. The product price cannot be calculated since the costs are yet to be determined. However, with the model presented above, we can quickly estimate prices and calculate our revenue once we obtain the necessary information to calculate the VC. One thing to note would be the supplement’s price. The supplement’s price refers to the price of the shrimp’s dietary supplements, which we will sell to aquaculture facilities. We’re only taking 40% of the supplement’s price, as the power industries’ revenue will cover the other half, while we handle the cleaning and installation of the product.

Without calculating our total cost, it would be impossible to set a suitable revenue that would enable us to earn positive profits. Therefore, the equations presented above will provide an appropriate model for calculating profits and revenues, taking into account our customers’ needs for the listed materials.

Recycling Byproducts

Rather than framing carbon capture as an additional cost, we created a business model that repurposed excess cyanobacteria biomass into secondary revenue streams. In addition to reducing carbon emissions, the used-up cyanobacteria that are no longer photosynthesizing, which are left in our product, can also be incorporated into dietary supplements for marine animals, such as shrimps, for immune and digestive benefits. By utilizing our product wastes in feeding shrimps and other aquatic animals, we can alleviate stress in aquacultured fish and shrimp (Abdel-Latif et al., 2022). To ensure that the cyanobacteria in our products are recognized as safe for animals and the ecosystems, the waste byproduct will undergo purification processes, including plasmid curing and enzymatic detoxification, which remove both the engineered plasmid and the toxic substances the cyanobacteria carried. Additionally, we planned to contact organizations and companies specializing in and acknowledged for biosafety evaluation criteria, such as the Organisation for Economic Co-operation and Development(OECD), to confirm our waste byproduct. Aligning waste byproducts with the OECD principles ensures that they are not only safe for animals but also for the environment. In 2016, the OECD raised concerns about the impact of transgenic organisms on the environment, humans, and other animals in Chapter 1 of its report. For instance, OECD pointed out the concern of whether the transgenic organism would increase the pathogenicity of DNA: “when the foreign DNA does carry a virulence factor, the possibility that this gene could contribute to the pathogenicity of the genetically engineered microorganism, or whether the virulence factor provides resistance to host defense mechanisms…”(OECD, 2016). By coordinating our product with the document’s metrics, we ensure that our cyanobacteria-based feed is harmless to both animals and the environment.

Legalization Strategy

1.1 Carbon Fixation Device GM Cyanobacteria Approval

1.1.1 Approval Status in Taiwan

The first phase of the entrepreneurial section involves the controlled use of a genetically modified cyanobacteria strain within a carbon fixation device. For the carbon fixation device as illustrated above, there is no environmental release and no entry into the feed/food chain until the second phase. Thus, we classify the activity of employing carbon fixation as industrial contained use of a genetically modified microorganism and require authorization from the Ministry of Environment (MOENV) for contained GMO operations at the installation site. Since the carbon fixation machinery requires constant maintenance and supervision to ensure maximum efficiency, we also need to comply with occupational safety and wastewater management regulations. These will be under the Ministry of Labor and the local Environmental Protection Bureau, allowing for the contained use of GM cyanobacteria under 24-hour surveillance.

A more detailed breakdown of the document will include several essential aspects of the maintenance of the carbon fixation device, such as the engineered strain (including construct map, gene insertion, and antibiotic resistance genes), as well as the complete design of the device’s architecture. Since the carbon fixation device will be regulated under an Institutional Biosafety Committee-approved plan, with inspection and compliance reports, our company will be able to trace incident notifications and possible malfunctions in the devices we send out, ensuring safety for both the environment and the laborers.

1.1.2 Approval Status in the U.S.

In the United States, the primary pathway for the carbon fixation device to enter the industrial sector, without environmental release and without food/feed use, is through the EPA’s TSCA Biotechnology Program (US EPA, 2015). As a GM Synechococcus elongatus PCC 7942 with anticipated commercial use, it must be TSCA-notified. Additionally, since the cyanobacteria strains are not on EPA’s Tier I and Tier II lists, our team needs to file a Microbial Commercial Activity Notice (MCAN) (Microbial Commercial Activity Notices (MCANs) Table | US EPA, 2025). The MCAN application should include details on the recipient organism and engineering, similar to the documentation process required in Taiwan. The MCAN also articulates that if devices are distributed at customer sites with live organisms inside, the MCAN must be applied to downstream sites and practices, as well as meet the requirements for confined structures.

Since the process requires no food/feed entry into other organisms, the FDA does not need to be involved. However, our company needs to maintain local wastewater and air quality standards. Another requirement the company also needs to consider is shipping live cultures to consumers. This process must comply with the relevant DOT/IATA packaging regulations (“IATA/DOT,” n.d.). In essence, we will seek EPA’s TSCA-contained use authorization via MCAN submission to demonstrate that our carbon fixation device complies with U.S. safety regulations.

1.2 GM Cyanobacteria in Shrimp Dietary Supplements

1.2.1 Approval Status in Taiwan

The successful implementation of our product’s second phase relies on meeting the strict requirements of Taiwan’s food safety administration. To ensure consumer safety and efficiency on a global scale, our team aims to establish a solid foundation in Taiwan, holding reputable licenses that conform to safety standards. Derived from the phase I aspect of our project, the GM-derived cyanobacterial biomass will act as an aquafeed ingredient for the shrimp species. Since the genetically engineered cyanobacteria are grown in closed reactors using purified CO₂ feedstock, we will register under the Feed Control Act with the Ministry of Agriculture (MOA) and Bureau of Animal and Plant Health Inspection and Quarantine (BAPHIQ), Taiwan’s agriculture regulator and its inspection arm. These highly regulated institutions will facilitate the contaminant-control program specific to industrial CO₂, which will encompass multi-stage gas purification and lot testing for metals, PAHs, and dioxins.

Moreover, the team hopes to invest more resources in shrimp studies under the influence of genetically modified cyanobacteria to demonstrate safety and improved SGR/FCR, alongside independent laboratory certificates proving the absence of recombinant DNA/protein in edible tissues, which complies with TFDA contaminant limits. Furthermore, once approved by the institutions above, our team also needs to prepare labeling limited to approved feed claims, while providing third-party certificates for non-viable GMO status, and maintaining inspection-ready QA. The implementation of multi-approval steps, including MOA/BAPHIQ for feed registration and TFDA-approved tissue analytics, will highlight the lawful use of GM cyanobacteria biomass in shrimp feed and the acceptance of shrimp for human consumption.

1.2.2 Approval Status in the U.S.

After establishing a foundational and credible approval in Taiwan, we aim to bring the success of our product to the global market. To ensure consumer safety and facilitate the international release of our product, we are pursuing Generally Recognized as Safe (GRAS) status for our genetically modified Synechococcus elongatus PCC 7942 cyanobacteria strain in the U.S through the FDA regulations. Genetically engineered Synechococcus elongatus PCC 7942, intended for shrimp/human consumption, does not appear in the FDA databases under the GRAS status. However, our team has developed a general streamlined approach to maximize the probability of getting GRAS approval. First, we will pursue a GRAS (Generally Recognized as Safe) conclusion for a defined article of commerce derived from engineered Synechococcus elongatus PCC 7942 under 21 CFR 170.570, which includes Title 21 of the Code of Federal Regulations. Part 170 deals with human food, and Part 570 deals with animal food/feed (21 CFR Part 570 -- Food Additives, n.d.; 21 CFR Part 170 -- Food Additives, n.d.). This article focuses on dried biomass produced in closed systems, such as our carbon fixation device, with a validated kill step and a specification stating that no viable cells were detected. The collection of documents will contain information about the engineered cyanobacteria, including specifications, a detailed breakdown of genetic modifications, and proof of the elimination of specific hazards.

Furthermore, the documents will also contain information on the intended usage and exposure of the shrimp and the human population. Second, we need to conduct experimental trials on the ingestion of engineered cyanobacteria by organisms to ensure their tolerance. Third, if the research presents justifiable evidence, our team will pitch our product to sponsors and professionals for review, aiming to reach a possible consensus that the substance is safe for both shrimp and human consumption. Finally, the sponsor and our team will submit a GRAS notice to the FDA center for approval.

The significance of conforming to FDA safety standards and regulations stems from the fact that multiple countries rely on FDA approvals as the cornerstone of their regulatory processes. Therefore, achieving GRAS (FDA) approval can facilitate a product's approval in the U.S., while also aligning with similar regulations on a global scale, allowing for a smoother path to integrating cyanobacteria biomass into shrimp products.

Go-to-Market Roadmap

Our commercialization strategy follows a four-phase approach, as illustrated in Figure 6, designed to mitigate risks during deployment while establishing credible market tracking in Taiwan’s emerging carbon trading landscape.

Fig 6. Roadmap of Go-to-Market Strategy

Risk Assessment and Mitigation

After discussing with a chemistry specialist Ms. Tori, we identified that although the photobioreactor leverages well-established biological mechanisms, industrial application introduces both technical and operational risks. Each risk has been mapped to a potential mitigation strategy to solidify its scalability in real-world conditions.

1. CO₂-induced acidification
   High concentrations of dissolved CO₂ can lower pH in the photobioreactor. Integrating Ms. Tori’s feedback that dissolved CO₂ in the photobioreactor would cause the medium to become more acidic, we conducted pH simulations using CO₂-enriched air (as described in the “Results” section), which showed a trend in pH changes indicating a stable, relatively consistent pH over extended time periods. The pH level remains within the tolerance range for our S. elongatus PCC 7942 strain, which is typically between pH 7 and 9.
2. Temperature conditions
   As the target customer has been defined as facilities operating purification or scrubbing systems, high temperatures from industrial outputs will not be a significant concern for the photobioreactor. Temperatures lower than 25℃ should also not be a primary concern, as reducing temperatures would require additional energy.
3. Biomass accumulation
   An increase in cyanobacteria biomass in the photobioreactor may reduce the efficiency of CO₂ fixation and its use as an energy source. Our photobioreactor provides a pipeline to drain the liquid cyanobacterial biomass, allowing companies to refill every month. Since the biomass is treated as a revenue-generating process, scheduled monthly extraction is encouraged.
4. Regulatory acceptance and biosafety concerns
   Use of genetically modified microorganisms may face market restrictions. However, the lab-grown Synechococcus elongatus PCC 7492 strain is widely studied (Adomako et al., 2022). The bioreactor's design as a closed-loop system also ensures contained use and prevents dispersal.

References