Team:SDU-Denmark/Implementation

Implementation

Implementation

On this page you will find information about how we would like to implement our product into the world. We have completed the different models discussed from the page about “entrepreneurship” to get better understanding of the potential of our company. For a more detailed description of the models and our thoughts have we created a business plan.

Introduction

Current medical treatment for depression has proven inadequate for a third of the patients suffering from moderate to severe depression. This phenomenon has been named treatment-resistant depression. Furthermore, depression has steadily increased over the last few years, with more significant spikes following periods of prolonged isolation during the COVID-19 pandemic. This has increased the international demand for better psychiatric treatments.

Newer treatment modalities using psychedelic drugs have been suggested as a potential way to treat all types of depression and multiple other mental health disorders such as post-traumatic stress disorder, generalized anxiety, and stress-induced symptoms. One such psychedelic drug is psilocybin, an active compound found in multiple fungi with fragile addictive properties but highly effective and prolonged therapeutic effect.

Current manufacturing of psilocybin is expensive and is performed either through a purification protocol or through production in yeast. With the production of psilocybin through E. coli using tryptophane, we aim to make it considerably cheaper to produce and manufacture psilocybin and related psilocybin-based medicine to treat depression

Organizational Structure

Our company will start with seven people in total because we will start as a small business and will only need a small staff. The organizational structure of the team will look like the following illustration, later expansion of the company will result in more staff.

Business Models

Here is a walkthrough of different models used to create our business plan.

Business Model Canvas (BMC)

BMC, short for business model canvas, is a helpful model to visualize the building blocks needed to start a company. This has been a useful model that gives a good overall idea of our company’s values, purpose in the market, and what the company needs to get started.

The model indicates a promising start for our business and that the company should be able to expand in the near future if the demand for our product is high enough.

PEST-Analysis

The PEST analysis is a model meant for identifying factors that might be subject to change in our business's Political, Economic, Socio-cultural, and Technological spheres.

We have identified the potential opportunity and threat factors that could influence the four domains in areas that would affect our business model in the future. This has provided us with an overview of what changes we need to be aware of during the manufacturing of psilocybin in the years to come.

Porters Five Forces Model

The aim of Porter's Five Forces is to determine the branch-specific threats companies face from competitors, suppliers, customers, and substituting product lines. We use this to create an overall picture of the market surrounding psilocybin production, and the current competition.

From the analysis of our market using Porter's five forces, we determined that our company would be one of the few big competitors in this branch-specific market. Likewise, our product would be a strong competitor in the market, with our comparatively low price and clean product.

Value Chain Model (VCM)

The aim of using the value chain analysis is to find the overall competitiveness of this company. This model also includes different values for the company, like further education of the staff members and constant development of the technology in use.

Our values are to educate our staff members and make it attractive to stay in the company to further develop the technology used in the bioreactor. This will ensure optimization of the synthesis of psilocybin.

SWOT Analysis

The SWOT model aims to sum up our company’s internal and external strengths/ weaknesses and the possibilities and threats concerning the market that the company is entering.

The model shows promising results since the company has already overcome the problem with the key enzymes needed to produce psilocybin cheaper. This is done by modifying the key enzymes so that the E. coli bacteria can produce psilocybin with a more inexpensive substrate, which is tryptophan.

Detailed Business Plan

Provided below is the detailed and extensive version of our business plan.

From Lab to Industry

A part of our future aspects is to plan how to improve, optimize and upscale our psilocybin production from a laboratory scale to an industrial (bioreactor) scale. To improve our understanding of this element of our project, we contacted José Luis Martinez Ruiz, a lecturer in fermentation technology at DTU, who helped guide us through the thought process. Note: Parts of the following processes (step: 1-2) were accomplished throughout our project.

Stepwise establishment of an industrial-scale production

HPLC for extraction and purification

We will use industrial reversed phase HPLC for extraction and purification of psilocybin from our E. coli. The same method which we use are done when working with mushroom that produces psilocybin[1].

Firstly, we will lyse the E. coli bacteria to gain access to the molecules inside the bacteria, which is where the psilocybin molecules are located. We can then use Reversed-phase HPLC because it is a helpful tool to separate the molecules that the organism contains and so that we can obtain a clean batch of psilocybin which is an important step in the purification of our product. The separation is determined by the hydrophobicity of the molecules, which makes psilocybin one of the first molecules to be separated due to the molecule being overall hydrophile[2].

Safety measures in regards to bioreactors

It is important to take precautions when working with GMOs and especially in large-scale production such as a bioreactor. This means that it is important to avoid that our organism is not released when operating or maintaining the bioreactor. The most likely situation is spilling drops or aerosols when handling the culture inside the bioreactor. A less likely situation is leakage or breakage of the bioreactor where the culture spills out in bigger quantities. It is therefore important to train our staff to avoid or handle these situations in the most correct way. Handling GMOs are discussed further in our section about “safety forms”. In addition, future work could involve introducing a kill switch to our cell culture, so when exposed to certain conditions outside our production facility, the bacteria would be killed. Inspiration is from an earlier iGEM team, iGEM Pasteur Paris 2018, who has worked with such a kill switch initiated by temperature shift from 37°C to <22°C, which is ideal for our bioreactor grown bacteria, as they would only reach such low temperatures if they were to leak from our bioreactor.

References

1. Thomson BM. Analysis of psilocybin and psilocin in mushroom extracts by reversed-phase high performance liquid chromatography. J Forensic Sci. 1980;25(4):779-85.
2. Skidmore MA, Turnbull JE. Chapter 6 - Separation and Sequencing of Heparin and Heparan Sulphate Saccharides. In: Garg HG, Linhardt RJ, Hales CA, editors. Chemistry and Biology of Heparin and Heparan Sulfate. Amsterdam: Elsevier Science; 2005. p. 179-201.

Communication