Our preliminary research sought to answer the question, "What major environmental and health problems affect people today?" An important aspect of a biological engineering project is to first start with a problem that people want to have solved. Upon discussing this, we came up with more poignant and open-ended questions: "What problem are we trying to solve? What current methods exist in addressing the problem, and what new approaches might be tried? How does engineering biology provide a tool, or act as a component in a larger plan of action to solve the problem? Is engineering biology a necessary or desirable approach in this solution?"

Before attempting any wet-lab work, or making any major design considerations, we considered these questions carefully. Our process of asking these questions, reaching out to doctors, and looking at current synthetic biology solutions were crucial in helping us determine the direction of our project.

On this page, we’ll discuss the questions we asked to determine if our project would be safe, useful, and an overall benefit to the world.

Why a GMO?

Bioengineering an organism introduces the risks associated with a genetically modified organism, but relieves the risk of simply not having the medicine at all and reduces dependency on shipments. The biosynthetic process eliminates the risk of adding toxic ingredients, a situation that has happened in poorly regulated conventional production factories^[2]. Chemically synthesizing these products requires harsh chemicals and requires removing those chemicals before human consumption, which is not a perfect process. The genetic changes to these organisms won’t be transferred to humans upon consumption, and fewer purification steps are required to prepare our products for human consumption than chemically synthesized alternatives.

To learn more about our organism of interest, check out our page on our target organism!

Why Acetaminophen?

The choice of host is intimately tied to the medicines that we could produce. We aim to biosynthetically produce acetaminophen, a common mild anesthetic and antipyretic recognized by the WHO as an essential medicine^[1] due to the feasibility of recreating the metabolic pathway in a cyanobacteria. However, in many countries with lower regulations and faulty policies regarding drug manufacturing, acetaminophen can be synthesized with lethal toxins that result in hundreds of deaths worldwide^[2]. Acetaminophen is often used in conjunction with opioid pain medications postoperatively to enhance pain relief, thus reducing reliance upon opioid pharmaceuticals^[6].

To learn more, take a look at our page on acetaminophen metabolics.

Why Vitamin B₁₂?

We aim to produce human usable vitamin B₁₂ because it is one of the few vitamins that Arthrospira platensis does not adequately produce. Vitamin B₁₂ proves to be a leading global vitamin deficiency and one of the most difficult vitamins to naturally consume, especially for vegetarians^[7]. Vitamin B₁₂ deficiency can lead to megaloblastic anemia and demyelinating nervous system disease^[8]. Additionally, both vitamins B₁₂ and B₉ are considered important prenatal vitamins for nervous system development^[9].

To learn more, take a look at our page on vitamin B₁₂ metabolics.

Is all of this safe?

It is important to consider that we are creating a proof-of-concept rather than an immediately implementable product. The safety concerns involved at the proof-of-concept stage are less complex than those of the implementation stage, and the safety concerns must be addressed at both stages to have a clear direction moving forward.

For example, one concern is that the project currently uses antibiotic resistance as the selectable marker for transformants. However, a future application of this in a clinical medical setting outside the laboratory would need to use a different selectable marker strategy in order to avoid the possible release of antibiotic resistance genes to the environment. This consideration brings us back to the research, outreach, design, and implementation questions that are a critical part of our human practices approach.

Another safety consideration is the dosage of the product, and the reliable determination of dosage. How will those using our product be able to know the dosage? What in our preliminary proof-of-concept and modeling provides insight on finding correct dosages? To determine product yield, we dove deeply into modeling the metabolics of our organism. Click here to learn more about how we modeled yield!

The edibility of the future host organism was a key safety consideration. We considered the implications of using a non-toxic, non-pathogenic organism as a model for a GRAS organism, which could be taken as a supplement rather than a prescribed medicine.