Difference between revisions of "Team:Manchester/HP/Gold Integrated"

Beyond the bench, the world educates us on ethics, sustainability, social justice, safety, security, environmental impact and intellectual property rights - information which further shapes the direction of our research. We have engaged with experts from different fields to make sure that our project and its execution can be responsible, safe and sustainable. In this page, we highlight specific interactions from stakeholders that have directly impacted and shaped different parts of the project. Click here to our silver Human Practice page to see the full list of different experts we engaged with!

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Water Industry

Exploring the water industry taught us a lot on how great scientific ideas may not be feasible in the real world. From the start of our journey, we thought about the water industry as a potential market for the implementation of our project in real life. However, we simply did not know the current state of the UK water industry and whether or not synthetic biology that incorporates genetically modified organisms would be accepted as an innovative solution, given how controversial it can be.

We talked to six different experts - five of which were from water companies - to learn and understand the current state of the water industry. The full list of our interactions can be found in our silver Human Practice page. The most important information that we gained from our interactions is that there are no barriers to innovation using synthetic biology and that regulations in the water industry are now more flexible in accommodating new innovation. As long as we can prove that our project is cheaper, reliable and safe to use, water companies will be interested. We have summarized our findings in an infographic that can be found here.

Now that we know the current state of the industry, we need to know how our project works in real life and how it can fulfill the necessary criteria to make it appealing to water companies. So we had a site visit to Davyhulme Treatment Works where we were shown the basic process of water treatment, from separation of sludge to water treatment through biological means through a tour around the site. Since Davyhulme does not treat phosphate, we asked for data about the wastewater they treated to provide us some realistic parameters on the expected concentration levels of phosphate.

Figure 1. Concentration of phosphate in incoming wastewater to Davyhulme Treatment Works in the past 12 months

After permission was granted, we were grateful to be given access to a small part of the data that is specifically about phosphate. We used this data in our continuous culture model to estimate the production cost of our bacteria and used Davyhulme as a real life scenario to estimate the cost of treating wastewater for a year. This allowed us to determine the economical feasibility of our project and also led to a discussion on alternative synthetic biology strategies that could be employed as a cost-reduction strategy.

Furthermore, we had a discussion with Sara Lyons, one of the technical managers of the site, in regards to the execution of our project in treating phosphate. Sara encouraged us to be more creative and to think about other ways our project can be used outside of the treatment plant. She explained to us how most of the phosphate usually originates from detergents and perhaps it might be more feasible if we can reduce the phosphate levels of the wastewater before it reaches the treatment plant and before it gets mixed up by other wastes. We discussed this idea with the rest of the team and thought about incorporating our project within dishwashers and washing machines. In this case, Phosphostore must work in an environment in high pH and temperature and therefore, we determined the viability of this idea by testing the thermo-stability of our PPK enzyme to see whether it can withstand high temperatures. Check out our experimental page to learn more!

Intellectual Property

As the paper that we based our project on cited a granted patent, we wanted to explore intellectual property in more detail to determine how this may influence our project. As none of our team members have any experience in intellectual property rights, we consulted experts in the field to seek guidance and answers. We contacted Dr. Rick Watson from the University of Manchester Intellectual Property office and Dr. Linda Kahl from the BioBrick Foundation. Through e-mail exchanges and a phone call discussion, the case of intellectual property became much clearer which directly impacted the development of our business plan and consequently shaped our experimental ideas. Click here to read our full report on intellectual property!

E-mail Exchange with Dr. Rick Watson - University of Manchester Intellectual Property (UMIP)

We wanted to know whether our project would be viable for a patent. To understand this, we reached out to Dr. Watson from the University of Manchester Intellectual Property (UMIP). Through e-mail, Dr. Watson gave a very thorough explanation that helped us to understand the patent situation of our project.

We were told that a granted patent is different than a patent application because if the patent has not yet been examined, we do not know for certain which of the claims are approved as written by the applicant, or which of them may be modified or refused as part of the examination process. In addition, we learned that holding a patent in a certain territory will give a monopoly not only over that territory but it also stops products created outside from being imported into those territories.

If we were to commercialize and patent our project, we learned that we will have to consider all previous patents and all previous scientific literature known as the ‘prior art’. This is because to be patentable, our invention would have to pass four basic tests:

1. Is it novel? Has our idea been thought of before, and put into the public domain by either us, or someone before us? - if our idea is not novel then it fails this test and we cannot patent it

2. Our project will have to have an ‘inventive step’ that is different from other previous patents - and not just an obvious thing to do for someone who has the average level of understanding of our subject area

3. Is it industrially relevant? Will our idea be commercially useful?

4. Is it excluded? Some types of invention are not patentable due to the ethics involved, including many biotechnology related ‘inventions. Also, one cannot simply patent a pure scientific discovery

In addition to checking whether our invention can be patented, we will also have to balance out the commerciality of our project. If we were to patent this project, would it only cover a very narrow scope of protection? If so, could competitors easily ‘get around’ our patent without infringing us by producing a similar system with slightly altered components? Would the invention ultimately have a good chance of making us or our company more income to cover the cost of developing the idea and protecting it? If not, there would be no point in spending time and money on the patent in the first place.

Phone Call with Dr. Linda Kahl - BioBricks Foundation 29/07/2017

We wanted to confirm our understanding on the Intellectual Property side of our project in the context of the iGEM competition and the use of BioBricks. We then reached out to Dr. Linda Kahl, Senior Counsel & Director of Ownership, Sharing and Innovation for the BioBrick Foundation.

From our call, we gained some confirmation regarding the BioBrick Public Agreement and what it means for Users and Contributors. We learned that the User and Contributor agreement only protects users against the claims by the person who signs the Contributor agreement and it would not protect users from any third party claims. This means that if a User submitted a patented part into the iGEM Registry and the patent owner does not sign the Contributor agreement, the User would be liable for a patent infringement lawsuit.

We realize that this may possibly have had happened in the past with previous iGEM teams that are unaware of IP issues. However, Dr. Kahl explains that it costs at least 3 million dollars to pursue a patent infringement lawsuit. Therefore, it is highly unlikely for anyone to file a lawsuit against iGEM or the BioBricks Foundation unless there is 3 million dollars or more worth of damages.

We then briefly discussed the Intellectual Property rights in the context of our business plan. Dr. Kahl advised us to consider the patent landscape to see who else is working in our field of interest. We were also advised to carefully examine the claims of the issued patents and see whether parts of our project are covered by the patent.

Lastly, we talked about iGEM and learned that the reason why anything we disclose in the Jamboree (wiki/presentation) cannot be patented is because patent laws generally say anything disclosed in public is already in the public domain and cannot be patented. There is, however, a one-year grace period after public disclosure where the inventor can still file a patent application, but this grace period is available only in the US and a few other countries.

*Phone call was conducted by Owen, Adam, and Theodore*

Industrial Scale

We wanted to explore how to implement our project in real life. This includes figuring out how to produce our bacterial product in a large industrial scale. Upon our initial research, we thought about producing our bacteria in a continuous culture system but in reality, we do not know whether this would be financially viable or not. We had a lot of questions regarding production cost in an industrial scale. Therefore, we sought out to contact John Liddell from the Centre Process of Innovation to answer some of our questions. Through a phone call, we were able to obtain information and resources that enabled us to estimate the production cost of our system through a mathematical model.

Phone call with John Liddell from the Centre for Process Innovation (CPI) 24/07/2017

To get a better understanding of expanding our project in an industrial scale, we contacted John Liddell from the Centre for Process Innovation, a UK based technology innovation centre that helps companies to develop, prove, prototype and commercialize products and processes.

One of the main things we learned is that it’s hard to accurately estimate the cost of production as there are a lot of different factors that will have to be considered: the type of bioreactor used, the size of the bioreactor, the type and amount of medium used, growth rate of organism and various utility cost (cost to sterilize and maintain). We initially thought that growth medium would be one of the biggest factor for cost. However, John explained to us that for E. coli, the medium may be about £1000 in a batch system using a 1000L tank. But again, he told us that this will depend on the type of medium and said that molasses and glycerol are among the cheapest sources of glucose.

We briefly discussed about our idea of culturing our E. coli bacteria in a continuous culture system. John suggest that if we were to consider starting up a business, the idea of using a batch culture is probably best during the initial stages. As the business expands and the demand of our product has increased, only then it is advisable to proceed to move and invest on a continuous culture system. He reasons that the bioreactor might be quite expensive for an initial investment and recommends us to rent an existing bioreactor from a manufacturer which would be cheaper in the short period of time.

Nonetheless, he challenges us to try our best to estimate the cost of our production in a continuous culture system to see whether our project can be financially feasible. He gave us some books and resources that would help in cost estimation. Through those resources, we were able to find a rough estimation cost which we used in our modelling and business plan.

*Interview was conducted by Owen, Amber, Adam, Theodore*

Legislation

In envisioning our project in real life, safety and GMO legislation is inevitably one of the most important factor we have to consider. After some initial research on the UK GMO legislation, we contacted the Department of Environment, Food and Rural Affairs (DEFRA) to answer some of our questions about the legislation in the context of our project. Through a conference call, DEFRA explained to us the procedures that one will have to go through for any commercial use of GMOs.

Conference Call with Department of Environment, Food and Rural Affairs (DEFRA) 25/07/2017

*To respect privacy, the names of those in the call are kept anonymous*

In envisioning the implementation of our project in real life, we wanted to understand the regulation and legislation process that we would have to address. We had a conference call with DEFRA to discuss this issue. We explained to DEFRA how we envision our project to work in real life. We would grow large cultures of bacteria and then place them in panels covered by a membrane that allows water to pass through but keeps the bacteria inside.

One of the things we discussed was regarding the different legislation between ‘contained use’ and deliberate release of GMOs. We were not sure whether our project would fall under ‘contained use’ since our engineered bacteria is still exposed to the environment so we briefly talked about the application process for deliberate release of GMOs. DEFRA advised that it could not provide specific guidance in this case because it would require further details of the nature of the activity (species of bacterium, exact genetic modification, containment measures etc). However, theoretically it could be argued that similar activities might be regulated under ‘contained use’ if the environmental risk assessment demonstrates that the GM bacteria are effectively contained.

Key points from our talk can be seen below:

1. Applicants will have to determine whether they apply on deliberate release or the contained use of GMOs. For our project, we will have to prove that our device (panel and membrane) is robust enough to keep our bacteria in when placed in the environment to argue for applying to ‘contained use’.

2. Guidance and regulation of non-plant releases of GMO is currently geared towards clinical trials. In clinical trials, they look at the level of attenuation of any pathogens that is used and the level of biological containment. When it comes to experimental releases, they will consider biological containment as well as physical containment measures. A kill switch could come into the category of biological containment but even a kill switch would be quite a new application. Regulators would expect a lot of detail in the environmental risk assessment.

3. In a deliberate release of GMOs, DEFRA will publish the application online on gov.uk (previous applications are recorded there as well). The applicant is also required to state an advertisement of their intended use in a national newspaper (such as the Times, Telegraph, or Metro). DEFRA will also invite representation for public consultation where the public can make comments on the safety or any environmental/human health risk that may occur due to the release of GMO. Only scientific concerns/comments are accepted and considered by the Advisory Committee on Releases to the Environment (ACRE) as part of their deliberation.

4. Although decision about the legislation of research into GMOs can be taken in a national level, decisions on the commercialization of GMOs have to be taken at a European level at the moment (while the UK is still in the EU). Anything beyond the EU will depend on the GMO legislation in whichever country the applicant would like to commercialize in. However, some third world countries may not have any GM regulatory system at all. In this case, then it is possible that these countries may require the applicant to gain approval in the EU first which has a well-respected GM regulation.

*Conference call was conducted by Owen, Amber, Alice, Theodore*

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 <p>Furthermore, we had a discussion with Sara Lyons, one of the technical managers of the site, in regards to the execution of our project in treating phosphate. Sara encouraged us to be more creative and to think about other ways our project can be used outside of the treatment plant. She explained to us how most of the phosphate usually originates from detergents and perhaps it might be more feasible if we can reduce the phosphate levels of the wastewater before it reaches the treatment plant and before it gets mixed up by other wastes. We discussed this idea with the rest of the team and thought about incorporating our project within dishwashers and washing machines. In this case, Phosphostore must work in an environment in high pH and temperature and therefore, we determined the viability of this idea by testing the thermo-stability of our PPK enzyme to see whether it can withstand high temperatures. Check out our experimental page to learn more!</p>