Team:TU Delft/Practices

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• Achievements
• Project
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• Notebook
• Hardware
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• Practices
• Collaboration
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• InterLab

• Work Space
• Safety
• Day Notes
• Protocols

• Prizes and Nominations
• Giant Jamboree
• Medal Requirements

• Team Members
• Advisors
• Team Work Attributions
• Media
• Sponsors
• Acknowledgements

• Description
• Strains
• Linking Cells
• Affinity Tags
• Printing Biofilm Layers
• References

• Overview
• Parts
• Part Collection

• Overview
• Making 3D Biofilms
• The Biolinker
• Design and Integration
• DIY Manuals
• Protocols

• Overview
• Testing Biolinker
• Dutch iGEM Teams Meeting
• Cooperations

• Overview
• Regulations
• Ethics
• Experts' Opinions
• iGEM Community
• Biolink P&P Tool
• Business Plan
• Outreach

• Results
• Protocols

• Overview
• Kinetic Modeling
• Curli Formation
• Biofilm Strength
• Time for Printing

Policy and Practice

External environment influences the design of new technologies. Human practices, public engagement and education.

Overview

Subtitle or summary goes here. Should be short - two or three sentences.

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Regulations

Remember to include safety also. Subtitle or summary goes here. Should be short - two or three sentences.

This section first discusses synthetic biology regulations, and then details possible regulations of our project. Synthetic biology is a multi-disciplinary science that has seen much advance in past years. However, there still is some confusion about what regulations apply to the field, because Synthetic biology is a broad term. When one or more synthetic biology aspects are specified, discussions about regulation and safety are clearer.

Different regulations apply for different regions. In the European Union, the European Commission considers to apply the existing regulatory framework of GMOs (European Commission, 2010). In the USA, the regulatory framework of Biotechnology applies and adaptations are made to address SynBio novelty (Carter, 2014).

Worldwide, the United Nations Convention on Biological Diversity (CBD, 2011) targets three objectives that focus on:

Conserving biodiversity.

Sustainable use of biodiversity

Fair and equitable sharing of benefits arising from the utilization of genetic resources.

The objectives concentrate on implications of releasing synthetic organisms, cells or genomes into the environment. However, despite the best intentions of this convention, their findings seem orientative, not leading to major changes in policy worldwide - countries and regions maintain their own way of regulating synthetic biology. For example, the USA is not bound by the CBD decisions, and other wealthy countries with strong biotech industries oppose them (UK, Australia, Brazil, etc.)

With respect to biofilms, specific regulations are almost non-existent. One of the causes for this regulatory gap is political and industrial lack of understanding of biofilms.

Regulations (of biofilms) are non-existent in North America, and still in their infancy in most of Europe.

Jonathan Tyler, CEO Tyler Advanced Corrosion Technologies, Questionnaire on Biofilms and 3D biofilm printing.

The biofilm industry is generally regulated with respect to bacteria present in the biofilm. Thus, diverse regulations may apply. A special case appears when conducting clinical studies; regulations are very strict. Clinical studies are investigations on humans intended to discover or test the effects of medicinal products (European Commission, 2001). We found out from both interviews and regulatory documents that this type of studies are cumbersome because of regulations, research being possible on in strictly controlled and licensed environments.

Showing something in vitro only very rarely translates to clinical use, as the worlds are very far apart.

Steffen Eickhardt, Head of Biofilm Test Facility, The University of Copenhagen.

This is a gap that Biolink could fill - if bioprinted biofilm testing reliability could get closer to that of clinical testing, we would have an easier and safer way to test products. Instead of having to pass through strict regulations of clinical testing in order to ensure the highest quality of a test, artificial test conditions could created with 3D-printed biofilms. In this sense, it is easier and cheaper for industry to work with biofilms. Another dimension is safety. Clinical testing is strongly regulated because it poses significant health and environmental risks. When testing a printed biofilm, there is no live test subject, and therefore minimal safety risks.

Another regulatory field we consider is bioprinting. Bioprinting is a highly debated topic, because it is new and unexplored, with various moral, financial and political interests at stake (Mearian, 2014). Conflicts mostly exist in the area of tissue printing with human cells (or other living cells). Bacterial bioprinting is not yet regulated - we propse that bacterial bioprinting adopt regulations of different fields. By merging regulations of bioprinting and biofilms, we assume that environmental and human safety, biodiversity, and legal ownership issues are taken in account. One field offers control over printed items while the other control over bacteria used to print items. Moreover, the open-source character of our project allows for transparency - science, regulatory and societal stakeholders can contribute to shaping 3D biofilm printing in a responsible and safe way for the future.

In conclusion, our 3D biofilm printing may be a future alternative to clinical testing, a safer and less controversial option for testing biofilms and anti-biofilm products. The Biolink project is driven by regulations that help control harmful bacteria and ensure that no ownership issues arise with printed items. Depending on what types of bacteria are used to print the biofilms, if the Generally Recognized as Safe (GRAS) status is granted, 3D biofilm printing is allowed.

Ethics

Subtitle or summary goes here. Should be short - two or three sentences.

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Praesent ultrices tincidunt ipsum, vitae tempor nibh porta ac. Fusce consectetur neque et dolor vestibulum iaculis. Nunc pretium turpis at arcu tempus vehicula. Nam nec accumsan metus, ac tempus tortor. Aenean euismod elit vitae ex ultrices pulvinar. Etiam rhoncus non urna vel volutpat. Donec ut erat ornare, faucibus quam a, posuere urna. Phasellus at nisl sed erat ultricies commodo vel ut mauris. Morbi ac mauris dui. Cras sit amet ornare nisl. Suspendisse lectus mi, ullamcorper et dolor a, vulputate condimentum velit. Morbi dolor eros, cursus euismod magna sit amet, tempus volutpat quam. Morbi at est sed erat efficitur lobortis nec non elit. Integer urna nisi, dapibus nec magna non, pharetra sodales felis. Fusce dignissim elit sit amet purus aliquet, quis luctus tortor commodo. Donec viverra enim vel ultrices iaculis.

Social and Industrial Impact

Subtitle or summary goes here. Should be short - two or three sentences.

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Praesent ultrices tincidunt ipsum, vitae tempor nibh porta ac. Fusce consectetur neque et dolor vestibulum iaculis. Nunc pretium turpis at arcu tempus vehicula. Nam nec accumsan metus, ac tempus tortor. Aenean euismod elit vitae ex ultrices pulvinar. Etiam rhoncus non urna vel volutpat. Donec ut erat ornare, faucibus quam a, posuere urna. Phasellus at nisl sed erat ultricies commodo vel ut mauris. Morbi ac mauris dui. Cras sit amet ornare nisl. Suspendisse lectus mi, ullamcorper et dolor a, vulputate condimentum velit. Morbi dolor eros, cursus euismod magna sit amet, tempus volutpat quam. Morbi at est sed erat efficitur lobortis nec non elit. Integer urna nisi, dapibus nec magna non, pharetra sodales felis. Fusce dignissim elit sit amet purus aliquet, quis luctus tortor commodo. Donec viverra enim vel ultrices iaculis.

The iGEM Community

For a complete policy and practice assessment, we thought it would be nice to not only include companies and research groups, but also the iGEM community.

Since a lot of iGEM teams are dealing or working with biofilms or co-cultures, our technology could be fruitful for a lot of these projects. In this section we will show you how our project could be used in combination with other iGEM projects. With these examples we show that our DIY printer and the biolink system form an useful addition to the iGEM community. The application scenarios described below are discussed and written together with the iGEM Berlin and iGEM KU Leuven team. Their validation that our project could be a nice addition to their projects was satisfactory.

iGEM Berlin

The iGEM team of Berlin uses synthetic biology to develop a molecular filtering machine. This project has great opportunities in solving the problems with microplastics finding their ways into the wastewater treatment plant. During the wastewater treatment, the microplastics are not removed sufficiently. The ‘escaped’ microplastics are taken up by organisms living in rivers, lakes and the oceans, but also by human beings through the food chain. To date, no scalable approaches has been found to solve this problem.

Luckily, the iGEM team of Berlin has the solution for the problem with microplastics; a molecular filtering machine. Their proposed filters consisting of a surface made up of cellulose to which bacterial flagella will be immobilized. The attachment required for this will be achieved via a cellulose binding domain. The single flagella-subunits, also known as flagellin, will be interlinked with plastic-degrading enzymes. Thus, this system enables an increased specific surface with highly catalytic activity.

We believe that combining our projects would open up even more opportunities. With our nanowires, we provide a stable structure with the bacteria used for the filtering machine. With our 3D printer, layers of bacteria can be formed in a predesigned way. Another advantage of this technique is that the enzymes produced by the bacteria can covalently bind to the nanowires (Botyanszki, Tay et al. 2015). In this case, the scaffold of cellulose is not required anymore. Moreover, the printer and nanowires generate a highly flexible machine, since every cell type and every enzyme could potentially be produced. One of the requirements posed by Berlin’s team is that the filter is highly flexible in use, so that it can be used for different types of water. So, by combining these technologies, the filtering machine, proposed by Berlin’s iGEM team, becomes even more attractive.

KU Leuven

KU Leuven team developed a ‘proof-of-principle’ which can form the basis for unravelling the secrets behind pattern formation. Patterns are formed by engineering bacteria themselves in a controllable way, by using different types of chemicals.

The similarity of our projects is the formation of certain structures with bacteria. Our printer could facilitate the process of making patterns in a more reproducible and automated way. This could be useful for the formation of artificial bones, by using bacteria that can produce porous structures similar to bones. With our printer we can design a unique bone structure exclusively made for the patient.

Another application for a collaboration would be to use the nanowires in combination with the cell-cell communication approach of KU Leuven. Their engineered bacteria could form an addition to the formation of specific biofilms with our nanowires. The moment bacteria find a suitable location, with the method of KU Leuven, the production of nanowires will be induced. Then, the bacteria will be fixed to this location.

By using these two example we have proved that combining our projects would proceed in future applications. To achieve this further fundamental research is required in combination with practical engineering.

Outreach

Day of wonder, RIVM, Studium Generale. Subtitle or summary goes here. Should be short - two or three sentences.

Synthetic biology has a lot of opportunities, for example in the improvement of healthcare and the production of sustainable energy. However, the idea that we could create "new" life with synthetic biology, is for a lot of people kind of frightening. Within our outreach part, we taught the public the basic concepts of synthetic biology. Moreover, we showed that the improvement of living creatures, by human kind, has been performed for ages. Finally, we discussed our project and its possible applications. Due to the multidisciplinary team, we already practiced the science communication by discussing everything in such a way that the whole team could understand it.

A Day of Wonder

During the first week of June, the international Festival of Technology (iFOT) was organized for and by students of the Technical University of Delft. During the week, a rowing event was organized, a Heineken bridge was built by civil engineer students and many more activities took place. In order to officially close the festival, A Day of Wonder was organized on the fifth of June.

Description of the event

A day of Wonder was the spectacular final of an entire week of celebrating technology. The event gave intellectuals and curious minds a chance to see innovations on the edge, with a mix of technology, music, art and great food. The Health Area was located in the Aula where all projects related to health topics were presented, ranging from end projects of master students, such as the Exoskeleton and the Buddy, to the fall course in which cameras were used to register the exact movement during the process of falling. We had the opportunity to be part of the health area and present our own project to the visitors of the festival. Our aim was to teach the public more about synthetic biology and to make them excited about our project.

Our stand

Since the festival was for everyone interested, ranging from young to old and higher to lower levels of education, we organized our stand in such a way that we could explain the basic concepts of synthetic biology and the iGEM competition. In order to teach, in a visual way, what synthetic biology is, we designed two puzzles, representing two types of bacteria. With these puzzles, we could explain how genes can be transferred from one bacteria to the other. Moreover, we brought some microscopes and lenses (built with Lego) to show the people how to enlarge pictures.

Activities

To have an interactive activity, we gave the public the task to write down their first thought when they hear about bacteria. The replies ranged from ‘dirty’, ‘zombie apocalypse’ to E. coli. In our opinion it was really funny but useful to see what the general knowledge (and opinion) is about bacteria. Our main attraction was the functional 3D printer that we had lent from Frank & Frens. With the printer we were able to show the public how the process of 3D printing works, what we want to do with the bacteria and why 3D printing could lead to more precision and accuracy.

With our project we aim to print a well-defined biofilm in 3 dimensions. Since the biofilm can be created at a certain rate and pattern, it is possible to create a well-defined structure. In order to show the existing problems, we have used pictures of dental plaque and biofilm formation within pipes to show them.

Winner of the contest

Bio³Dimensions Business Case

Educating people is not only about giving lectures, it is also about offering the opportunity to feel and think the subject. We wanted to give this opportunity to students of the TU Delft in the form of a business case.

Bio³Dimensions – Business Case

Educating people is not only about giving lectures, it is also about offering the opportunity to feel and think the subject. We wanted to give this opportunity to students of the TU Delft in the form of a business case. The assignment made students think about how they would use a 3D biofilm printer for a practical, marketable use, and present their idea. Since the participants had different expertise, we started with a general introduction to iGEM, synthetic biology and our project. After that, groups of three persons were formed,each group having one of the iGEM team members as a tutor.

Based on the information about our project, the different groups could use one of our applications or come up with one on their own. They also had to choose their market of interest, think about the drawbacks of their technology and sketch a market plan. In the end, every group presented their idea with a poster pitch. We closed the meeting with a free barbeque to thank the participants, and continued discussions in a more informal setting.

Group Ideas

Smell Eaters

The first group presented a shoe sole on which a biofilm with the smell eaters (good bacteria) was printed and attached. The group knew about some “good bacteria” as being used for treating bodily odour. The “good” bacteria would produce substances that inhibit the odour compounds made by “bad bacteria”. Based on this, the group wanted to apply the idea to the shoe industry. Since the feet shape and size differ from person to person, the printer is useful because it can be adapted to every type of feet. The project’s poster is shown in Figure 1.

According to this group, the technology could be useful for everyone with smelly feet. Since you want to make it suitable for every type of feet and shoes, they propose coupling to stores specialized in making individual shoe soles. In the future, they want to implement a system that could protect the user for ‘escaping’ organisms.

Figure 1.

Purity straw

The second group provided a solution for the contamination of drinking water, the Purity Straw. The straw has a membrane inside, which can clean contaminated water. The straw is suitable to use it in most situations where access to clean water is limited.

The printer gives the opportunity to print different kind of membranes, which makes it useful for every type of contamination.

Figure 2.

The team surprised us with a short but to the point market strategy on their poster (Figure 2). According to them, the product could be useful for humanitarian organisations in helping developing countries to get clean water. Moreover, the army can get access to clean water everywhere. With this technology they target especially remote areas, over populated regions and areas struck by disaster. Finally, why did they think the technology was useful and beneficial? Well, it is easy to use, the material is light and therefore easy to take with you. Finally, it could be small.

The discussion after the presentation contained some nice questions:

“What about the fact that people could swallow the bacteria during drinking? The team answered with: “People should just adapt to this situation, since the bacteria in the straw are less harmful than the bacteria present in water”. Actually, by using this device, the bacteria should have a GRAS status;

According to a student of industrial design, such a technology already exist. So, this team did a really nice job here!

Lumy

Another team came up with a totally different application of our construct; ‘The Lumy”. Lumy provides a sustainable version of lights for bicycles. The Lumy can be ordered at a special website in every shape you like. The product you will receive at home consists of a sticky layer, a layer of nutrients (medium), the biofilm which has the property to emit light. So, the only thing you need at home is medium for the bacteria! Since batteries are not necessary anymore, the product could be highly sustainable.

The Lumy is especially useful in a country like the Netherlands (students for sure), since everyone uses a bikes often. Moreover, since the equipment is closed, the bacteria cannot escape.

Figure 3.

Bactoplast

The final concept presented was similar with the idea Groningen’s iGEM team had two years ago. The printer will be used to print the biofilm required at that moment for healing processes. The so-called bactoplast is placed on the wound and will increase the healing process. Afterwards the signal molecules of the wound will disappear. This signal activates bacteria’s kill switch. Therefore, there is no danger of bacteria that will escape.

Figure 4.

Since it is difficult to keep the Bactoplast fresh, this group aimed for hospitals and doctors. However, it would be even nicer if people could use the device at home. In that case, the bactoplast can be used in every kind of wound.

Wrap-up

After the hard work of the teams, it was time to relax. We organized a free barbecue with drinks in the company of the Netherlands’ very occasional, sun. We all enjoyed the evening and received constructive feedback from the participants. Students who at first knew little about the field, found out many interesting things. They left with a good impression about synthetic biology and its future.

Business Plan

How to write a Business Plan and Biolink's Business Plan

With this section we aim help other iGEM teams by providing a guideline for writing a successful business plan. Further more we present Biolink, a revolutionary way of 3D printing biofilms into a desired form, adding control, replicability and automation over classical biofilm formation methods.

How to Write a Business Plan

A business plan is useful for more than just attracting investors. It helps both the project team and the audience gain a business perspective, which complements scientific and social views. We want to help future iGEM teams to write a business plan specific to their project, so that the business perspective is more thoroughly addressed in future iGEM projects. Therefore, we propose a few guidelines, and direct iGEM teams to literature for further details of business plan writing.

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Start with target audience

Before starting to write a business plan, you should identify the target audience of your project. In general, a business plan is a basic document required by any financial investment source. It is an opportunity of an entrepreneur (who wishes to create a new venture) to impress investors and attract funding. (Mason, 2004).

However, even if you are not planning to start a business from your iGEM project, writing a business plan can be useful to communicate the key business elements to a different target audience: the iGEM community and the general public.

Structure the Business Plan

A classical model of a Business Plan can be found in literature as described in (Abrams, 2010). There are many books and websites with various advice about writing such a document. The structure can be variable, depending on what information you want to give and to whom. Regardless of what the theme of the project is, its business plan should include at least the following core chapters:

Executive Summary. The definitory part of any business plan, the executive summary provides a concise and attractive overview of the entire project. It is meant to both inform and catch the audience’s attention. Keep in mind that it has to be attractive for an audience with various backgrounds - both scientific and nonscientific.

Company / Project overview. High level description of the elements of the business/project and how they integrate with each other. Motivation and core arguments supporting why the project will be a success are included here.

Market / Industry Analysis. The project is enveloped within the context of an industry/market. Market research is done on current and future market trends, competition, complementary products, suppliers, clients, etc. Based on this information, a competitive analysis is made to establish how the project (future company) could succeed in the respective environment (for example, by a SWOT analysis - will be explained later).

Product / Service. Describes the final product / service meant to be sold. Advantages or disadvantages of the product should be compared to existing similar solutions. Included is a description of R&D activities, evolution of product (life cycle), and legal issues or patenting if the case.

Marketing & Sales strategy. What customers can you sell to, how to communicate with them, how to sell the product/service. Moreover, this section must describe a long-term strategy on how to maintain and increase client base, while fending off competition.

Management and Organizational Structure. Essential to any project or company are its people and their interactions. This section should detail what kind of people the company will employ (both personal and professional typologies) and how they will be managed within a chosen organizational structure.

Social / Environmental impact. Although this section is not a must-have for regular business plans, it is highly recommended for iGEM. A core iGEM goal is to make Synthetic Biology known and understandable to the world. Therefore, it is important to predict how the project will be perceived by society, and how society can influence the evolution of business. NOTE: One should be aware not to repeat information that is already treated in Policy and Practice modules. Rather, impacts found in the Policy and Practice section should be analysed here from a business perspective.

(Optional) Investment and Financial forecast. This section is traditionally necessary for a business plan, but an exception can be made in the context of iGEM. As the target audience are not necessary investors, but the iGEM community and public, this section may be skipped. Moreover, financial forecasts and investment plans require considerable effort and expertise in order to be convincing. It is better to skip this part than write an unrealistic plan.

Use business theory and concepts

When writing a business plan, content information needs to be supported by existing business theory. Here are some points to consider:

Critical factors for new businesses. One can start developing a business plan by considering four essential factors that make or break a new business as proposed by (Sahlman, 2008). Here is an example of analysis that focuses on four interrelated factors critical to new businesses:

1. People: Initiators of business and external parties with key services and resources (suppliers, experts, lawyers, accountants, etc.). Execution skills and quality of people count more to realizing a business than the business idea.

Key points:

a. How familiar are team members with industry players and dynamics.

b. How well known is the team and it’s people within the network, what reputation does it have?

c. Quality, knowledge and experience of team members.

2. Opportunity: Product/Service sold, customers, growth/diffusion curves, barriers towards success.

Key points:

a. Is the market that the project targets large and fast growing enough?

b. Can market share be easily obtained (new, emerging market) or is a fight needed with entrenched competitors (mature/stagnant market)?

c. How is the product sold (pricing scheme), to whom, why is it compelling for the customer to buy it? How expensive is it to acquire and retain a customer - access to customers is easy?

d. How much capital equipment and assets are needed to support setting up business and sales.

e. What’s the competition in the market? What are their strengths, weaknesses, resources? How would they respond to our technology? Can alliances be formed?

3. Context: regulatory environment, demographic trends, other uncontrollable and variable factors.

Key points:

a. Is there a favorable regulatory and macroeconomic landscape?

b. Are there growing trends that encourage products and services in the industry?

4. Risk and Reward: Assessing what can go right and wrong and how the entrepreneurial team respond.

Key points:

a. What risks are there and what measures can be proposed to diminish them?

b. Can a deal with investors be simple, fair and emphasize trust rather than legal ties?

c. Can the business be seen as an adaptable series of experiments that are open to change? Can experiments be made to test feasibility?

Enabling or hindering elements of a business. To consider both internal and external factors that can block or help an emerging business, a SWOT (Humphrey, 2005) analysis can be made. A Strength-Weakness-Opportunity-Threat (SWOT) is only one method of many, to evaluate these factors.

Marketing/Sales Business models. To gain clarity and structure how a product is marketed and sold, sales models can be used. In addition, comparison with sales models of successful companies can be helpful. After deciding on the model, a graphical scheme can be used to illustrate the entire supply chain. This shows where the new business comes into play in the chain.

Industrial trends and market niches. Choosing where to sell is a prerequisite for production, as each industry has different trends and market segments to sell into. Trends can help forecast what to sell, and identifying untapped market niches suggest where to sell.

Inter and intra-organizational structure. Depending on the company goals, products, industry and market, there are several organizational structures that can be chosen to better support the business model. Structures range from mechanistic to organic with various combinations between them (Burns & Stalker, 1961).

Science communication. Often there is a communication gap between scientists and managers or public. Science communication involves relaying specialized knowledge to non-specialists and is key to mutual understanding between different background people.

Innovation management. As iGEM promotes creativity and innovation, considering how they can be included in the business plan is essential. Innovation patterns and concepts applied on a project help understand how innovation pushes an idea to a marketable application. For example, Henderson and Clark identify four types of innovation depending on its impact on existing competencies and their linkages - Incremental, Radical, Modular or Architectural Innovation (Henderson & Clark, 1990).

Identify and fulfill audience expectations

The business plan should align with, and support the entire project. Readers will be confused if too much new information is added, or if the information is not consistent with other sections of the project. We propose taking in account the following key points:

Direction The business plan helps delineate a strategic direction, clarifying project goals and progress to both iGEM team members and audience. On the long run, a strategic direction aids in keeping the project on track and observing if adjustments are needed.

Integration When doing research for the business plan, new knowledge and arguments come into play. Sometimes it is easy to deviate and include concepts irrelevant for your project. Make sure that new insights stay on subject by always relating them to your project. If they don’t relate, focus on only a few concepts that can be strongly tied to the project.

Validity Prove that assumptions and analysis are valid. Validity can be enhanced by supporting assumptions with interviews, questionnaires (or other data collection methods) and literature reviews.

Combine theory and practice within structure

After deciding on what theoretical concepts can explain project aspects, they can be included within a chosen structure. The executive summary should be left for last, as it is an overview of all the essential aspects identified through analysis. A business plan does not have to be rigid. It should be perfected as the iGEM project progresses.

Final thoughts

Finally, we stress the point that a business plan should be useful. It should help guide the project with respect to what is feasible or not from a business perspective. Moreover, it should be interesting to read for your audience, reflecting ideas of how the project could develop into a business.

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Biolink Business Plan

Executive Summary

Introduction. For testing biofilm removal products, it is essential to produce an artificial biofilm yielding reliable results. Biolink proposes a revolutionary way of 3D printing biofilms into a desired form, adding control, replicability and automation over classical biofilm formation methods. The many fields of application (biofilm research, industrial and healthcare product testing), growing trends of 3D printing industry and Synthetic Biology, and positive feedback received so far offer promise towards our success.

Biolink was born from TU Delft’s team participating in iGEM 2015. Our aim is to develop a creative, yet simple solution solving a complex problem in the biofilm-related industries. Certain biofilms, forming in or on our body, pose serious threats to our health. Products, such as toothpaste or antibiotics, aim to remove these detrimental biofilms. To measure removal efficiency, products are tested on biofilms formed in laboratories. Because biofilm growth is difficult to control, these artificial biofilms are unlike naturally occurring ones. This translates into unreliable product testing - a disadvantage to both companies and their clients.

Our solution can mitigate the disadvantage. On the one hand, safety and efficiency of biofilm removal products can be increased, if biofilms formed are closer to real conditions. On the other hand, increased automation and control over biofilm formation yields a cost advantage for production processes. Biolink brings together more than just biofilms; it combines the novel fields of synthetic biology and 3D printing into forming a new competency. By partnering with 3D printing manufacturers, we want to offer a highly-customized and specialized 3D biofilm printing service.

To gain a competitive edge, Biolink will form and preserve close relationships with clients, concentrating on high quality and specialization, rather than mass production. Clients targeted are from both healthcare production and industrial manufacturing industries (companies selling biofilm removal products). Co-development of our service with our clients is crucial for achieving an optimal solution, tailored to their needs. We can find clients and 3D printer manufacturers leveraging our professional network gained through iGEM. Discussions already held with various actors from the industrial and academic setting seem encouraging. Moreover, reports of growth in both 3D printing and Synthetic biology industries reflect a favorable business environment.

The future business will build upon the iGEM team structure. The Biolink team structure will be versatile, so that it can easily adapt to special requirements of clients and speculate emerging technology. We are proud of being a strong team, with cohesion compensating for lack of experience. By adding team members that fill our expertise gaps, we will be able to competently run a company providing the service we are proposing.

With Biolink, we want to form an image that encourages creativity and sheds light over synthetic biology. Our current 3D printer is made out of a DIY kit that is easy to build. Moreover, we organized social events with students to see what they think about Synthetic Biology in general and our project in particular.

Company and Project Description

Our mission is to contribute to better and cheaper pharmaceutical and health products. By ambitioning to provide an innovative method of biofilm formation, we want to help increase the efficiency of manufacturing and testing processes. We deliver a partly automated, replicable and efficient solution by 3D printing biofilms. The method will partially replace some manual steps of current biofilm formation processes.

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Healthcare systems are developing all over the world, increasing the demand for pharmaceutical and healthcare products yearly. In order to increase supply, while maintaining or even lowering prices, the production process needs to be more efficient. Our vision is to partly automate biofilm processes for producing medicine and health care products, and removing detrimental biofilms that affect industrial equipment.

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In realising our mission, we are guided by our core values:

Integrity:

to be self-critical, to respect regulations and never knowingly act in the detriment of any group or individual.

Ingenuity:

to continuously seek for improvements of our project.

Openness:

to provide full access to our project results and methods, openly aiding anyone who requests help and accepting external ideas for improvement.

Harmony:

to synchronize with the needs of industry, the demands of our supporters and the expectations of society.

Collaboration:

to achieve more purposeful results by collaborating with other iGEM teams, researchers and industry.

Growth:

to gain expertise, communication skills and build a professional network, while enjoying the work we do.

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Project description - Why biofilm printing?

Beneficial and detrimental biofilms form naturally in nature. Research on biofilms is twofold: One - preventing and removing detrimental biofilms, and two - exploiting beneficial biofilms.

- Beneficial biofilms are grown for water and wastewater treatment, bioremediation of contaminated soil (from gasoline, chemicals, oil, etc.), microbial extraction of natural resources, and for producing useful compounds or substances.

- Detrimental biofilm research aims to efficiently prevent and remove biofilms appearing in a multitude of contexts. They can affect installations and equipment in the industrial landscape, form in/on the human body (plaque, skin affections, bacterial layer on skin, lung bacterial biofilms, medical implants), form on medical devices and cause infections (catheters, medical equipment, wound dressings).

Industries affected by detrimental biofilms (4Inno.com)

Biofilms cause well over a billion dollars' worth of damage every year in industrial settings, affecting human health and companies' abilities to manufacture their products efficiently

CBE, Montana State University

How does printing biofilms help the industry and end-user clients?

With respect to the detrimental biofilms, Biolink binds together biofilms, forming 3D shapes on which removal products are tested. Printed biofilms are very reproducible, thus more similar to each other than grown biofilms, making biofilm removal results more reliable. Moreover, automation makes the biofilm formation process more controllable, thereby increasing efficiency of testing. In short, production costs decrease and product effectiveness increases.

On the client side, thorough testing of biofilm removal products increases their safety and reliability. People are interested in efficiently removing detrimental biofilms, but are equally (if not more) concerned of negative side effects that may appear. Moreover, cost advantage for production companies can translate in either lower prices for customers, or higher quality of products through re-investment and innovation.

Concerning beneficial biofilms, we plan to expand in this field in the future. With cell-immobilization, the bioprinter could form several layers of different cells that through interaction, produce useful compounds. Biofilms can also be formed out of beneficial bacteria on 3D structures or on surfaces (filters, pipes, etc) for creating protective layers.

Industry Analysis (Abrams, 2003)

This section sets the industrial network in which our project operates as a business. An overview of potential customers, supply chain, competition, and industrial trends is shown.

Industry network description

Our Business Sector: Service & Manufacturing of Biofilms

Our Market Segment (by Technology): Biological Components and Integrated Systems (Transparency, 2015).

1. Potential Customers:

a. Health & Personal care companies (Colgate-Palmolive) - dental surface biofilm removal

b. Pharmaceutical companies

c. Biofilm removal and treatment companies (TACT Engineering)

- Removal of biofilm from air ventilation systems

- Removal from water/wastewater systems

- Removal from industrial pipes, containers, reactors, etc.

d. Biofilm research facilities (University of Copenhagen Biofilm Test Facility)

e. Antibacterial product testing companies (Innovotech)

2. Suppliers, Distributors, Sales

- 3D printer companies (UltiMaker)

- TU Delft research network (Industrial Design for 3D printing expertise and Life Sciences for Synthetic Biology purposes).

- Biofilm material providers (Bacteria providers)

- Biofilm research groups (Copenhagen University Biofilm Test Facility)

3. Competitors

There are some scientific publications where bacteria are 3D printed, with the purpose of studying bacterial colony behaviour and antibiotic resistance. (Connell, 2013). However, to our knowledge, this idea has not been commercialised. In addition, our ideas on applications are novel.

Nevertheless, there are multiple potential threatening companies or groups that could compete with us:

- Biofilm research institutes.

- Biofilm testing facilities.

- Industrial Biofilm removal companies.

- Healthcare/Pharmaceutical producers preventing or treating biofilms (such as plaque).

- 3D Bioprinter companies (printing human tissue or organs).

4. Similar products.

- 3D organ and tissue bioprinters.

5. Potential investors

- TU Delft Incubator: YES! Delft is a TU Delft supported organization that offers advice and space for starting a company. They also help with a starting loan and establish contact between startups and possible investor network.

- TU Delft research grants are also a viable option, as the project is currently held and supported by the TU Delft Bionanoscience Research Department.

- A corporation or established company interested in our project can invest in co-development. Such a partner/investor that can more easily support costs for perceived future gains.

Trends in industry & Strategic opportunities

Past and future growth of business sector:

- Biotechnology industries are slowly growing again after the downfall of the financial recession.

- Increased number and decreased strictness of FDA approvals in previous years. (Song, 2014)

- Synthetic biology markets are estimated to grow by an average of 33.8% yearly until 2018. (DALLAS, 2014)

Industries of operation: Synthetic biology, Pharmaceutics, Industrial biofilm removal, 3D printing. Each of these industries are either growing or stable, with no apparent threat of disappearing or drastically decreasing in size.

Barriers and Disadvantages of the industrial ecosystem.

Investors have high bargaining power; Because our project combines two relatively new technologies, it can be labeled as a high risk investment. This means that investors will be more reluctant to fund us, or demand high returns to compensate for the high risks.

Client high bargaining power; The nature of our customer intimate strategy implies that we have only a few customers for whom we provide a tailored service. Losing one client poses a high threat to the us, therefore placing our clients in an advantageous negotiating position. However, if we can become indispensable to our clients and difficult to imitate by other companies, the advantage can turn to our side.

Strong potential competition; A significant number of established companies with financial and technological strength can threaten our small business if they replicate our services.

Biotechnology industries historically have long development periods with low returns and tricky product approval cycles. Moreover, research requires high capital investment needs.

Technological Innovation and Adoption Strategy

In this section, we describe how Biolink can grow from idea to service. We describe the innovation process and utilize a strategic analysis tool: Strengths-Weaknesses-Opportunities-Threats (SWOT) Analysis to underline key elements that can help or hinder our technology and its emergence.

Type of Innovation. Biolink aims to improve a technological process by partly changing technology used, thus realizing a Technological Process Innovation. As the improvement builds upon the existing biofilm formation process, without any radical changes, we label it as incremental. The innovation aims to increase productivity and reduce costs of the entire production/research process. We argue that effects are not directly noticeable by biofilm removal products’ end-users.

Innovation Process. Because it involves advanced technologies, innovation will continue in an industrial and/or academic setting. We perceive three main actor groups enabling innovation:

Academia: the foundation of our project. The academic network can provide knowledge and finance to help kick-start and incubate innovation in the beginning. Within a business incubator, our project can reach a mature enough phase to begin industrial development.

Industry: By industry we refer to any industrial sector that utilizes (or is affected by) biofilms in some way relevant to our project. Collaboration with industry provides an application-oriented direction and financial support. Moreover, co-development with a company offers Biolink access to a larger pool of shared resources, and helps distribute risk.

3D printer producers provide us with a necessary enabling technology. We collaborate with them regarding 3D printer technology, integration with biofilm formation and analysing if market requirements can be fulfilled. An alternative to contracting 3D printer producers directly would be including students from Industrial Engineering in our project. Through this faculty within TU Delft, Biolink can gain future employees that could form a 3D printing department within our business, removing the need for external collaboration.

Adoption at organizational level. Following the innovation phase, we plan to market our product to companies with whom co-development was done. Pioneer companies who invested in co-development are best prepared to adopt our solution and continue to support it until it becomes profitable. Successful adoption of the new technology will encourage other companies to consider our services. This offers an incentive for business growth, expanding service breadth (different companies will want customized solutions) and specialization.

The SWOT Analysis highlights what internal and external factors can influence the evolution of Biolink. These factors mostly affect Biolink at strategic level (how the company performs on long term). Strengths and Weaknesses refer to internal characteristics of Biolink as a company and our capabilities of performing operations. Opportunities and Threats are external factors that might influence our progress.

Sales and Marketing Strategy

Sales business model.Biolink provides a full service: 3D-printing tools, set-up of equipment on-premises, training, maintenance and customization based on needs.

Customer intimate competitive strategy. To gain a competitive edge, we cultivate unique relationships with our clients. By providing an end-to-end service to just a few clients (instead of limited services for a large number) we achieve a double effect. First, we retain our clients on long term by gaining their trust and ensuring satisfaction. Second, the customer intimate strategy and high customizability offered will be difficult to imitate by competitors. (Treacy, 1997)

To achieve positive market results with this strategy we plan the following:

- openly communicate with clients to increase service efficiency and quality.

- offer consultancy on how clients can best fit our solution to their processes.

- invest in R&D improvements of our core services and for potentially radical changes.

- invest in providing high customizability of services based on customer requirements.

- provide on-premises installation, testing, maintenance and upgrades.

This strategy requires a strong understanding of clients and their processes. It also demands a decentralized company structure that can quickly react to changes in clients’ needs. (Treacy, 1997).

Management and Organizational Structure

We propose an organizational structure based on the iGEM team structure.To provide high quality, specialized and customised services for a small number of clients, we organize as a Holacracy (Robertson, 2007). Similar to the iGEM team structure, a holacratic organization removes hierarchy by distributing responsibility and power across distinct roles.

Just like in iGEM, people are responsible for certain roles (such as R&D, Sales, Customer support, etc.) while also being free to help out in other areas. In this way, employees are involved and responsible, feeling that they drive the company forward by doing what they are best at. People can have several distinct roles and work on several different tasks/projects.

For example, in a 3D printer project specifically designed for a toothpaste manufacturing company, a team of several members with various roles can be assembled to fulfil requirements. Some members are fully dedicated to this project, while others work on it in parallel with different projects. This structure supports high flexibility, reaction and development time, while encouraging innovation and creativity. While teams self-organize, an overview and general direction of projects is given by a broader circle containing the team - instead of exerting authority, it guides teams on the right track.

The holacratic organizational structure is graphically presented below (Robertson, 2007):

Because the holacratic structure involves high employee autonomy, it requires several traits from people working in this system (TheWorkologist, 2015). These traits are similar to the ones identified in freelancers and entrepreneurs:

Self-leadership and motivation

Personal productivity; drive towards efficiency without supervision.

Ambiguity tolerance; Ambiguity is beneficial for fast adaptation to change and creativity but may create confusion and lack of direction.

Psychological capital; the extent to which employees are efficient, optimist, hopeful and enthusiastic about their work.

Regarding our inter-organizational network, we believe that loose connections with industry and academia are appropriate for our type of business. In a loosely coupled network, actors have higher self-determination and are more observant of the environment. Therefore, we can be more adaptable. Because we will be a small, specialized company, we need to keep track of emerging technologies to quickly adopt them. Both size and organizational structure enables us to speculate opportunities and avoid threats faster than large companies. When an opportunity or threat arises, we can seek for help in our network and change certain relationships from loose to strong, until solving the issue.

For example, collaboration with a 3D printer manufacturer would need to be strong in the beginning, until a viable solution is finalized. Afterwards, loose connections with the 3D printing industry would be more beneficial, so we can scan for incremental advancements improving our existing solution.

People are the foundation for growing an idea for any business or project. Our team members’ backgrounds are diverse and can fulfil most of the functions needed to start a business. Strong cohesion of the group is also paramount for success.

Science and technology are most well represented by knowledge of Life Sciences, Chemistry, Biotechnology, Nanobiology, Physics, Biomedical lab-work, Computer Science and Systems Engineering. Each part would contribute to designing and constructing a 3D biofilm printer, programming and testing it, and growing the bio-gel needed for printing various biofilm structures.

Management of Technology expertise broadly covers the areas of entrepreneurship, leadership, management, marketing and business strategy, by working in collaboration with science-oriented team members. Basic Economy and Finance operations can be also covered temporarily until an accountant is hired.

Positive team dynamics is key to a successful project. After more than half a year of working and spending time together, we made an idea of how to combine our strengths and minimize our weaknesses. Because we have team members with both strong and no biotechnology backgrounds, we exercised science communication - an essential part in developing our project such that its usefulness is understood to non-scientific stakeholders. After practicing this type of communication in the team, we are better prepared to achieve impacting outreach efforts.

Building consensus. Successful science communication helps in building consensus between members with different backgrounds. In our case, while some team members support the usefulness and marketability of the solution, others ensure scientific soundness and validity. Productive conflicts that occur shape our project into something meaningful from several different perspectives.

Project limitations and acknowledgements

We acknowledge the limitations of our current team and project structure. First of all, for both cases of future failure or success, the structure and strategy of the company would need to be revised and adapted. Because prediction is nearly impossible, we acknowledge that the proposals in the business plan fit the present, but are fully subject to change depending on the evolution of events.

We identify some of the limitations that may hinder future business development.

For constructing the printer, we lack electronic, mechanical and industrial designers. This problem can be mitigated by co-developing the 3D printer with an external company or collaborating with Industrial Design within TU Delft.

We have limited work experience in business and industrial setting.

As students, our knowledge and professional network is still in development. Despite our large academic network (TU Delft, other iGEM teams, supporting organizations, etc.), our ties with industry are still thin. However, with networking efforts, this downside can be reduced during, and after starting the business.

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