Entrepreneurship

As part of our entrepreneurship efforts, we have conducted extensive research. This includes analysis on competing technologies, market sizing, buyer personas, a marketing & sales strategy as well as key milestones. We have also discussed our product with two experts to validate our assumptions. Furthermore, have created a business plan during a meet-up in Münster and we have garnered insights from an incubator in Frankfurt.

The issue of antibiotic resistance is a pressing global health and environmental concern requiring comprehensive solutions. Effective mitigation is anchored in systematic measurement and monitoring of the phenomenon. However, there is a deficiency in data collection and analysis, which is needed to understand the scale of antibiotic contamination, thus hindering the fight against AMR.

We are introducing a measurement tool utilizing a whole-cell biosensor, freeze-dried on paper strips and encapsulated within alginate capsules. This novel technology is engineered to offer precision, efficacy, and affordability in evaluating antibiotic concentrations and the resultant resistance.

High-Performance Liquid Chromatography (HPLC) is an analytical chemistry technique used for separating, identifying, and quantifying the components in a mixture of compounds. It is highly efficient and capable of analyzing complex samples with precision and accuracy, making it a preferred choice in various fields, including pharmaceuticals, environmental science, and food testing. However, the technology is often encumbered by its high cost, substantial equipment, and the need for skilled technicians to operate and maintain HPLC.

Liquid Chromatography-Mass Spectrometry (LC-MS) is a powerful analytical chemistry technique that combines the separating power of liquid chromatography (LC) with the quantitative and qualitative capabilities of mass spectrometry (MS). It is widely used for detecting and identifying a vast range of organic and inorganic compounds in complex mixtures. LC-MS is renowned for its sensitivity and specificity. Yet, it is similarly constrained by high operational costs, complex machinery, and the necessity for specialized expertise for optimal functionality and data interpretation.

UV-Visible spectroscopy measures the absorption of ultraviolet and visible light by a sample to determine its chemical composition and concentration. Specific wavelengths of light are absorbed by molecules in the sample, and this absorption pattern is analyzed to identify and quantify the substances present. UV-Visible Spectroscopy is often beset by sensitivity issues and the potential for interference from other compounds, along with being generally expensive and requiring significant space and skilled operation.

Enzyme-Linked Immunosorbent Assays (ELISAs) detect and measure specific proteins in a sample by utilizing antibodies linked to an enzyme. The test involves binding the target protein to a specific antibody, adding an enzyme-linked detection antibody, and then a substrate that the enzyme converts into a readable signal, often a color change. The intensity of the signal correlates with the concentration of the target protein in the sample. ELISA’s prominence stems from its specificity and sensitivity in detecting and quantifying substances such as antibodies, hormones, and antigens. Nevertheless, the technique is often seen as complicated, necessitating technical proficiency, and the reagents often require storage at -20°C, adding to operational complexity.

Lateral flow tests are rapid diagnostic tools that detect the presence of a specific analyte in a sample by utilizing a strip infused with reactive molecules. When the sample is applied, it migrates along the strip, interacting with labeled antibodies that produce a visible signal if the analyte is present. Lateral Flow tests such as Charm’s ROSA tests are noteworthy due to their streamlined, efficient design. However, their operational effectiveness may be limited by the requirement of an incubator and reader. Additionally, they require cost-intensive and at times ethically questionable production of antibodies.

Utilizing whole-cell based biosensors, our paper strips can be stored in the fridge and are easy to use, requiring no further equipment. The test solution simply needs to be placed on the paper strip. The technology is easy to scale and cheap to manufacture as it does not rely on specific products like antibodies, making it accessible to a wide range of users. The technology can easily be adapted to detect other compounds, making it a versatile solution for a variety of applications.

According to Fact.MR, the global market for antibiotic residue test kits is currently valued at approximately 185M USD (projected 333M USD in 2023) with an estimated CAGR of 6.1%. Assuming this is the Total Addressable Market (TAM) for our project, the Serviceable Available Market (SAM) can be calculated by focusing on our specific use case: Beta-Lactam antibiotics. This market is estimated to make up 34% of the total market for antibiotic residue test kits, which is approximately 63M USD. Assuming 10% market share, transforming our iGEM project into a business would result in a Share of Market (SOM) of 6.3M USD.

The market is currently dominated by established players like IDEXX Labs, Thermo Fisher Scientific, Charm Sciences or Perkin Elmer, which focus primarly on the food & beverage industry. We believe that much of the industry growth is still ahead: Due to the increasingly pressuring nature of AMR, health and environmental concerns along with corresponding regulatory trends will become major market drivers. Capitalizing on this trend, we will offer products specifically tailed to environmental monitoring such as customized testing solutions and digital service, thus enabling more intelligent monitoring.

We will launch our first go-to-market push with our paper strip and alginate capsule prototype, targeting primarily milk farmers, pharmaceutical companies and wastewater treatment plants in countries of the Global South. This will enable us to generate early revenues and learn from our customers, thus enabling us to iterate on our product and equipping us with resources to gain regulatory approval in countries with tighter regulatory environments.

We will progress by offering testing solutions in adjacent markets, such as hormones/endocrine disruptors, common medicine residues such as for Diclophenac, pesticides, mycotoxins or allergens.

We will further progress by offering testing strips which unite multiple tests for different compounds on a single strip, thus offering an even simpler testing experience for customers. Furthermore, we plan to allow customers to customize their test strips for a combination of compounds of their choice — or even for compounds of choice.

Lastly, our goal is to refine our biosensor technology into a multifaceted “detection platform”, which goes beyond testing by also including digital technology to track and coordinate testing, thus fulfilling complex monitoring and governance requirements.l

Our initial go-to-market push will be in regions characterized by lenient regulatory landscapes, such as in countries of the Global South. Apart from their regulatory landscape, these regions also often exhibit the benefit of having a greater need for our product due to a lack of measures that prevent contamination. We will predominantly utilize e-commerce channels and subsequently grow into the B2B and B2G sectors while at the same time navigating the regulatory environments in more regulated markets.

In order to make our product known to a wider audience and raise awareness for antibiotic contamination, we plan to give paper strips away to activists for free. Given that our products is based on widely-available materials and thus very cheap to manufacture, this is a very inexpensive marketing measure, which enables viral growth for us.

The product and market development is segmented into distinct milestones, initiating with the prototype development, followed by commercial production and market entry. As we advance, securing regulatory endorsements, intensifying B2B engagements, and diversifying our product offerings will be paramount, culminating in a robust B2G engagement strategy:

1. Development of Paper Strip & Alginate Capsule Prototype: The first milestone is a working prototype comprising of biosensors based on paper strips and alginate capsules. This prototype marks the cornerstone of our endeavor to provide a scalable, cost-effective, and efficient solution for detecting and monitoring antibiotic resistance.
2. Phase - Establishment of Production Facilities & D2C Sales Channels: Transitioning from prototype development, the next milestone is the launch of the commercialization phase. This step includes the establishment of state-of-the-art production facilities to ensure the consistent quality and scalability of the product. In parallel, we will create direct-to-consumer (D2C) sales channels, ensuring that our innovation is accessible to users, thereby fostering a customer-centric approach.
3. U.S. Regulatory Approval: Securing regulatory approval from the U.S. authorities is integral to validating the safety, efficacy, and quality of our products. This milestone underscores our commitment to compliance with stringent regulatory standards, paving the way for expanded market access and instilling confidence among potential stakeholders and customers in the U.S. market and beyond.
4. Expansion to B2B Sales with Specialized Team: With regulatory approval secured, our focus shifts to establishing dedicated B2B sales initiatives. We will deploy a specialized team to engage and collaborate with business entities. This team's expertise will be instrumental in customizing solutions, fostering partnerships, and elevating the adoption of our products within various industries.
5. Introduction of combined and customized Paper Strips/Alginate Capsules: Follwing our commitment to innovation, we will introduce combined and customized paper strips/alginate capsules. This ensures our products are not just universal but are also aligned with the unique requirements of specialized sectors.
6. Engagement in B2G Sales with Expert Team: The final milestone is marked by our move into the business-to-government (B2G) sector, facilitated by a team with specialized skills in navigating the complex procurement and regulatory landscapes characteristic of government contracts. This expansion exemplifies our capacity to offer solutions that are not only commercially viable but are also aligned with the public sector's stringent requirements and objectives.

Sonja Puhl is a business development manager antikoerper-online, an online retail store for antibodies and other laboratory supplies with over 4 million products. She graduated from RWTH Aachen as a M.Sc in Biotechnology. Furthermore, she has several years of experience in the field of oncology, pathology and in particular proteomic biomarkers.

Sonja Puhl stated that she is very aware of the growing accumulation of antibiotics but also hormones in our wastewater. Regarding that, Sonja Puhl suggested, that our paperstrips and Alginate capsules could be adapted in a way that also hormones could be detected. In this way, our project is extremly versatile and adaptable.

Currently, most of the antibiotics are being produced in India. Therefore, the water in India is much more affected comapred to nations like Germany. Germany and many other western nations purchase antibiotics from India as they are cheaper. Still, she mentioned the ethical difficulties of leaving countries like India in this high risk situation as multi-resistant strains come from places with high concentrations of antibiotics.

Sonja Puhl feels like there is some progress in Germany, including discussions on how to prevent the accumulation of anitbiotics and multiresistant pathogens in our wastewater. However, according to her, the current efforts are not sufficient and she would like more scientific communication and government action.

In her opinion, one of our major customers would be wastewater treatment plants. With the help of our alginate capsules, all wastewater treatment plants could monitor their water without any specific lab equipment. Furthermore, our paperstrips can be implemented in the development of improved water purification strategies that are under development just now.

Our paperstrips are similar to a pregnancy test or the COVID-19 test a way of quickly testing the presence of antibiotics in the water. In terms of our paperstrips, there are a wide variety of customers that could be intrested in them. As no special lab equipment is required, the paperstrips could be used by anyone resulting to the paperstrips being a sucessful potential product that could be implemented in industry.

Dr. Ionna Karamichali is a Biotechnology Specialist in the Field of Research and Business Development. In terms of entrepeneurship she is highly motivated in the field of startup business development and the project mangement field with an experience of 2 years. On top of that Dr. Ionna Karamichali supports women in STEM where she and and her team offer young women the opportunity to improve soft skills and get mentoring programs in certain specialization of STEM.

Given the need to stop the progression of antibiotic resistant pathogens, the incorporation of novel interventions aiding us to detect antibiotics is absolutely crucial.

In our interview with Dr. Ionna Karamichali, we learned that our paper strip might be a good approach to start as it is amenable to anyone. Since everyone is famillar with operating a pregnancy test or a COVID-19 test, people would be willing to try out our paper strips. Once we have convinced the customers with our paperstrips we could take one step further to introduce our alginate capsules.

Moreover, it is important to determine who our primary customers are. Of course, wastewater treatment plants come to mind first, however it is the government who has the most significant influence on whether money in invested in such inventions. Therefore, it would be a good shot to have the government as our primary customers. Moreover, it is important that we train our customers as not everyone is famillar with the progression with antibiotic resistance. Therefore, it is important to first sensitize our potential customers about the problem in order to urge them to buy our product.

The Unibator is the “incubator for innovation” at Goethe University Frankfurt am Main. It supports students, staff and alumni of all departments in the implementation of scientific findings and resulting business ideas into marketable products and services. Founders go through an 18-month startup program with the goal of developing a validated and scalable business model.

Our discussion with Innovectis/Goethe Unibator was primarily focused around programmes offered by Unibator itself, as well as around scholarship opportunities for startup founders.

In our discussion, we learned about the Unibator Startup Program, which serves to systematically support the selected startups. It provides infrastructure such as offices, support for finding funding opportunities and network and startup consulting. We also learned about the German EXIST scholarship and the Hessen Ideen scholarship, which provide support to startup founders, as well as the push! scholarship provided by the state of hessia, which provides a one-time grant to startups.

During the Junior Jam Meet-Up in Münster, we had the pleasure to not only meet other teams, but also participate in helpful workshops. One of those was "From Science to Start-Up" hosted by REACH-EUREGIO Start-Up Center, an incubator from this region. Our student leads gained insight on what to think of when building a company. They have assessed the possibilities and the future for B.L.I.S.S. After the Grand Jamboree is good time to reiterate to tranlate all our effort from the last year into a stable business model.

Special thanks to Chrisitina Weß, our coach for this day.

Figure 1: BLISS business Plan create during the Junior Jam Meet-Up in Münster.

Our innovative solution to combating antibiotic resistance centers around a unique paper strip embedded with a whole-cell biosensor and encapsulated in alginate capsules. This product is poised to fill the significant market gap caused by the lack of easy, affordable, and precise tools for measuring antibiotic concentrations and resistance. We’ve outlined diverse buyer personas, from dairy farmers to environmental activists, each with distinct needs that our product adeptly addresses. The market’s potential is underscored by the projected value of the antibiotic residue test kits sector, expected to reach $333M by 2023.

We're strategizing an initial focus on countries with more lenient regulatory landscapes, with plans to expand into B2B and B2G sectors, addressing the growing need for effective antibiotic monitoring tools. Expert consultations have corroborated the adaptability and market readiness of our product, and insights from an incubator in Frankfurt have equipped us with valuable knowledge on navigating the startup landscape. Our journey from prototype development to a global footprint is meticulously mapped, ensuring a systematic and impactful market entry and expansion.Con