Potential Customers & Unmet Needs

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Viraless analysis kit is designed for the detection of pathogens in different fluids, therefore it can be used in mitigation approaches and biosecurity and biodefense infrastructure. Target customers of our analysis kit include research institutions, Ministry of Defense, epidemiologists and sanitary specialists, biosecurity-focused companies. The main benefit of Viraless analysis kit is that in comparison to other existing detection methods it can also target synthetic biology-enabled engineered pathogens. Additionally, the possibility of using our analysis kit as either a stationary or portable device and results-interpreting software supplement going with it makes the kit a more user-friendly detection method on the market.

We have met with the experienced epidemiologist Dr. Dinara Alimkhanovna, Head of Biosecurity and Biodefense at NSCEDI (National Scientific Center of Especially Dangerous Infections after M.Aikimbayev) and have learned that there are problems in the field of outbreak detections in terms of the detection timeliness. Slow processing and delivery of pathogen detection assay results hinders early detection of an infectious disease. PCR is the most commonly used method for detecting pathogens in environmental samples and is also time consuming and requires additional preparation and training. Slow processing and obtaining of results is also associated with the equipment of detection methods. Namely, many of them are non-mobile and inconvenient for the untrained user. Additional preparation and training before testing and collection and transfer of samples to the place of analysis also consumes time.

Feasibility and novelty of the product

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In Kazakhstan the emerging concern of accidental release is especially relevant to the local population due to the High Containment Biosafety Laboratory (HCBL) located in Almaty, the most populous city in the country. The accidental release of pathogens and exposure to them due to the use of pathogenic organisms as bioweapons by terrorist organizations causes the conserns among the local population [1]. Adding to this overall consternation of biological warfare issue, the history of epidemics and recent outbreak of monkeypox virus makes more relevant the need for the defense and protection against these biological threats.

In 2020 the global market size of environmental monitoring was valued at $19.89 billion, and in 2030 it is estimated to reach $43.48 billion, increasing from 2021 to 2030 at a compound annual growth rate of 8.2% [4]. Following the COVID-19 crisis, the Biological Detection market along with the Wastewater/Effluent Pollution segment is forecasted to grow at a 8% compound annual growth rate [5]. To comply with the set safety standards, various industries are enforced by food, pharmaceutical, and environmental sectors to apply monitoring instruments for environmental water analysis.

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The safety of our end product was evaluated through the framework for assessing concerns proposed by the National Academy of Sciences, Committee on Strategies for Identifying and Addressing Potential Biodefense Vulnerabilities Posed by Synthetic Biology:

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More information of safety can be found in Proposed Implementation .

To upscale the bioprocessing of our recombinant protein system to an industrial level we need to go through upstream and downstream processing steps. For upstream bioprocessing, we will determine the expression rate of recombinant protein using algorithms developed to determine the expression of T7 polymerase. Received data will allow us to calculate the optimal quantity of IPTG in production. However, as we discovered in our project, these proteins will be best expressed in different expression plasmids like pET22b since it contains signal peptide sequences for periplasmic import and could contain a better promoter. It is important to note that recombinant proteins are required in very small quantities only to test the binding capacity of our antibodies on optic fiber (e.g. we can verify that kilometers of optic fiber work as expected using a few microliters of recombinant protein).

Lastly, utilizing full-size equipment like LUNA not only limits our system's applications but is also not affordable and requires advanced training for end-users. Therefore, we scaled down and adapted necessary equipment pieces into a backpack-sized hardware system that can be set up in its stationary form for wastewater systems or used as a portable tool by field epidemiologists.

As a result, we can produce aptamers depending on customers' request pathogen of detection on a large scale, supplying kilometers of optic fiber, mass manufacturing our portable hardware, and providing all end-users with easy-to-use software.

Development Plan

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Business Canvas Model

Skills and Capabilities

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To ensure that Viraless would develop into a successful business project, we must acquire specific bioentrepreneurial skills and capabilities. Those include strategic thinking, time management, communication, resilience, efficiency, sales, and networking. Strategic thinking means finding and developing creative solutions to problems and ways of sustaining business through thinking. Efficiency and time management are connected because efficiency implies successful problem-solving, while time management is responsible for delivering this solution on time. Strong networking and communication skills will help establish strong relationships within and without a business environment. Resilience is also an essential capability because it stands for recovering from difficult situations and being able to optimize solutions based on those constraints. In addition, skills in sales will assist in increasing earning capacity by building loyalty between end-users and businesses.

Stakeholders

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We decided to focus on external stakeholders because they affect the success of our project as a business model. External stakeholders of Viraless include government regulators, epidemiologists, biosecurity-focused companies, and local communities.

Since we will stick to the B2G model in our commercialization process, the primary stakeholder of Viraless would be the government. Our project would assist governmental regulators in several ways. First, Viraless, in its stationary phase, would help detect deliberate attacks in military zones. In other words, our device would protect deployed military members in high-risk areas. In its portable form, Viraless can test the environment of temporary occupation. Therefore, the government can install a strategic defense system based on our device. Moreover, the protection of the population from bioweapons usage is the primary priority for our government in the biosecurity sphere. Hence, our team has already scheduled meetings with the Ministry of Defense.

Epidemiologists, researchers, and biosecurity-focused companies also constitute our potential stakeholders. For epidemiologists, it is vital to have a transportable device that will rapidly detect pathogens' presence. As Dr. Dinara Alimkhanovna noted, these fundamental characteristics will allow epidemiology specialists to work in the field. Therefore, to consider those epidemiologists' unmet needs, we downsized the optical frequency domain reflectometer (OFDR) to make the device compact and easy to carry. Biosecurity-focused companies and researchers can determine the causes and sources of illness outbreaks from accidental releases or deliberate attacks.

Local communities also constitute our external stakeholders because they are the primary sufferers of bioterrorism acts and are the main target of informational attacks. As vaccinology specialists suggested, our team would try to prevent the influence of informational attacks and discard people's doubts by explaining our device's importance in detecting biological threats.

Long-Term Impacts

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We acknowledge that producing monoclonal/polyclonal antibodies for functionalization on an industrial scale would be expensive. Therefore from a long-term perspective, we plan to functionalize aptamers on optic fibers instead of antibodies because they can be easily made specific for any pathogens, adjustable, and have low cost in production. To accomplish this, we built upon existing software and wrote additional tools to obtain optimal aptamer sequences for our system.

We understand that it is necessary to focus on more markers for better coverage of the target pathogens. Currently, the Viraless analysis kit is focused on 4 biomarkers; for the future expansion of the project, we are planning to extend the use of the kit to more targets for more accurate detection of the orthopoxviruses and more specific differentiation between their strains.

We have yet to determine how long our system can maintain high sensitivity rates because, as time passes, antibodies or aptamers will denature and detach from the surface of the optic fiber. This process could be sped up by different toxins and chemicals in environmental samples, limiting the efficiency of our tool in its stationary phase. However, we need only small quantities of liquid for detection (500 microliters), which keeps its stationary form usable.

Regarding the commercialization process, we will stick to the B2G (business-to-government) model, which could be our advantage yet limitation. Many countries’ defense infrastructure legislative processes could deny them from utilizing our equipment and/or software. To limit such obstacles, we decided not to use cloud-based storage for our software so that it only runs locally, ensuring our end-users that we will not have access to their data.