Biotechnology Commercialization: Business Model Report

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Updated: Oct 26th, 2023

While the development of novelties in science is crucial, it is necessary to understand the application of this innovation within the biotech industry as well. Biotechnology allows scientists to use their knowledge about organisms and apply it to developing new models and processes of manufacturing. The question of commercialization is vital because this component is what allows the general public to benefit from the discoveries made by researchers.

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This paper aims to discuss the article “Enzymatic Assembly of Carbon-Carbon Bonds via Iron-Catalysed sp3 C–H Functionalization” and its prospective customers, markets, and approaches to using this concept in the biotechnology industry.

Prospects of Commercialisation

This section of the paper will focus on developing the model of business that will utilize new C-H bonds. The aim is to test the hypothesis regarding the applicability of this new method in biotechnology and manufacturing. The carbon-hydrogen bonds are considered to be challenging in regards to replication within the context of a laboratory, even though they can be observed in organic molecules (Zhang et al. 2018). Iron-based catalysts can help overcome the issues and limitations of the current technology. This model is more advanced than those that are currently used because, firstly, it involves iron and inexpensive metals and provides prospects for abiological alterations that are possible with this technology.

This presents implications for further research and the development of new technologies based on this model. According to Zhang et al. (2018, p. 67), “the use of the native iron-haem cofactor of these enzymes to mediate sp3 C–H alkylation suggests that diverse haem proteins could serve as potential catalysts for this abiological transformation.” Both chemistry and synthetic biology, which are the primary industries that will be discussed in this paper, can benefit from this development. For instance, the research demonstrates the synthesis of lyngbic acid as part of its practical application.

C–H functionalization has been researched by many scientists and can be described as a reaction in which the bond is split and replaced using a transition metal. For instance, articles by Daugulis, Roane, and Tran (2015) and He et al. (2015) describe varied approaches to catalysis with the application of different metals. Therefore, the competitor can use models similar to the one described in this paper.

The problem concept is that the current methodology of functionalizing carbon-hydrogen bonds is complicated and requires an application of costly materials, which impacts the efficiency of the process and the final price of the product. The study in question offers a novel approach that implies using iron as a cost-effective alternative. According to Davies and Morton (2017), C–H functionalization is a popular field of research and it can bring many benefits for chemistry due to the possible implication of changing the way chemicals are created.

This provides an understanding of the potential commercial use for the model described in the paper because it can be applied in a variety of fields. A product concept is a new approach to functionalizing carbon-hydrogen bonds with the application of iron. To facilitate customer discovery for this technology, one must understand the implications that this innovation has on the market.

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The customer creation process for this technology is the first step in identifying the prospective market and clients that will be able to license the functionalization process. Zhang et al. (2018) argue that contemporary biologists have a limited number of methods for creating carbon-carbon bonds. A new enzymatic strategy can help overcome this issue, facilitated by the limits of the modern technology that can work either with enzymes of the methyl group or by conjugating radical acceptor substrate (Zhang et al. 2018). Both the pharmaceutical industry and companies that manufacture plastic can benefit from this discovery because it offers a new way of synthesizing a C-C bond, which will improve the manufacturing process.

The innovative elements described in this paper are the new model of synthesizing carbon-hydrogen bonds through functionalization, which earlier could not be facilitated without novel metals. This model uses iron catalysis as part of the process. The use of protein and iron as catalysis for this technology can replace the current model that uses noble metal. Therefore, this strategy offers a more cost-effective approach to the functionalization of C-H bonds.

The high turnover and selectivity that arise as a result of this technology allow scientists to develop more novel methods of functionalization based on the model presented in this paper. According to Clarke and Kitney (2016, p. 243) “significant global challenges necessitate the development of even more effective manufacturing solutions.” The ability to manufacture C-H structures more efficiently will help companies improve their development process.

Moreover, this new methodology can make many biotechnology products more affordable in manufacturing. For instance, the industry can benefit from developing petroleum-derivatives both inexpensive and ecologically friendly (Green chemistry: Au naturel catalyst mimics 2017). Based on the proposed model, different complex chemicals can be manufactured, for instance, medications or various plastics.

Intellectual Property Potential

The intellectual property (IP) potential is the ability to patent the unique process of functionalization of C-H bonds using the iron. Dehns (2017) states that scientists can patent an idea to further license it, which will help define the specifics of the offer to companies that want to purchase the license. The best approach is to begin locally and file a claim within the UK, partially because the initial costs are estimated at a minimum of ÂŁ3,000 per application. Therefore, this technology can first be patented in the UK and offered to biotechnology enterprises and pharmaceutical companies in this country, and then operations can expand to the global level.

A PTC application can help researchers protect their functionalization strategy globally. According to Sherkow (2016), firstly, it is crucial to identify the type of technology that will be patented, which will help determine the specific procedures necessary. It should be noted that patents are essential for biotechnology enterprises because they enable the proper use of innovations developed by particular individuals.

According to Sherkow (2016), difficulties exist because many companies in the industry develop using a platform model, meaning that they create solutions to specific issues that can be further applied in a variety of industries. The author recommends focusing on patents that are designated to protect laboratory-developed tests, which is a concept that helps obtain a patent for a process similar to that discussed in this paper.

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It should be noted that although the approach offered in this article is novel, similar methods can be developed by competitors. Sherkow (2016) states that over 80% of the product’s value is lost if more than five rival companies are present in the market. Therefore, a danger exists with patenting IP for this functionalizing technology because in case scientists can use other non-noble metals for the process, the value of this strategy will be mitigated.

Firstly, it should be noted that there are several types of IP that have different implications for usage. According to Paul, Thangaraj, and Ma (2015), the best approach to biotechnology commercialization is patenting a discovery and proceeding to license the technology to companies that will work on the commercial product that will be sold to customers. It is evident that the proposed functionalization process has the potential of being applied globally; however, due to intellectual property implications, the implementation should begin at the local level.

Technology Platform

The size of the current market can be estimated using the information about the application of C-H bonds in manufacturing. The technology platform for this project is connected to molecular biology. This science enables a more efficient strategy for C-H bond functionalization that will allow creating chemicals more efficiently. It is facilitated through the improved process of catalysis and the application of iron.

According to Zhang et al. (2018, p. 70), “cytochrome P450 can acquire the ability to construct C–C bonds from sp3 C–H bonds.” Moreover, the list of selectivities for this experiment can be improved using different materials that can be found in nature. Therefore, the scientist will be able to adjust the process further and discover alternatives and the technology will benefit enterprises working in medical and synthetic biology industries.

Implementation can be easily facilitated in any laboratory because the method does not imply the use of sophisticated technology or rare materials. Therefore, it will be easy to replicate this functionalization strategy using the information provided by Zhang et al. (2018). Bottlenecks for implementation may include difficulties with obtaining a patent and possible replications of the technology by competitors.

Summary of the Customer Discovery Process

In summary, the process of customer discovery involves examining the technology and identifying prospective applications of it. This paper offers a new approach to C-H functionalization that can significantly improve the efficiency within synthetic biology and biotechnology industries, which is the main advantage of this innovation. Zhang et al. (2018) clearly defined the superiority of their model. The bottlenecks that exist and additional research that is necessary include a need to discover other models of functionalization based on the one that applies iron, which will help mitigate prospective IP disadvantages. Iron-based functionalization is more cost- and time-effective when compared to the competition.

Customer Validation

This section of the paper aims to develop an appropriate sales process for the new technology of enzyme synthesis for C-H bonds that can be repeated and scaled in the context of the real-life industry. The market base for this project involves biotechnology companies, organizations that produce medications, and companies that manufacture plastics. Because the technology offers a more advanced version of functionalization using iron, it can be argued that these businesses will be willing to license the process in question, which will help them save time and costs.

Value for the Market

The primary aspect of commercialization is the ability to replicate the process of C-H bond functionalization within other companies for the production of new materials. First, it should be noted that big pharmaceutical companies can benefit from this discovery because their research and development cannot deliver the same results. The author argues that despite the industry being advanced and producing thousands of drugs that target various diseases in the human body, many new models of treatments can be introduced. However, the strategy of functionalization described by Zhang et al. (2018) can be applied in other industries as well. For instance, synthetic biology that connects technology and biology can benefit from this as well.

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The Market, Benefit, and Its Value

It is anticipated that the market for this new technology is comprised of manufacturers in the biotechnology industry, for instance, pharmacological companies. According to the Allied Market Research, the market size of synthetic biology was estimated at $5.2 billion (Synthetic biology market to grow 2019). Moreover, it is anticipated that it will continue to grow each year by 23% until 2020.

Another market that this discovery applies to is pharmaceuticals and according to ABPI, the number of enterprises that work in this industry is approximately 573 in the UK (Number of biopharma enterprises 2017). Besides, the pharmaceutical industry in the UK has to be considered in the context of this report because the technology offered in this paper can be used by these businesses as well. According to Anekwe (2015), the overall value of this industry was estimated at ÂŁ56.2 billion in 2015, out of which ÂŁ32.4 billion were generated by large medical companies. It should be noted that C-H bond functionalization cannot be utilized in all the processes within the mentioned industries. However, there is significant potential for this technology.

The market distribution consists of pharmaceutical companies and enterprises that develop plastics. Besides, Clarke and Kitney (2016) state that biotechnology can be used to manufacture medicine, food, or fine chemicals. The authors mentioned that due to a variety of applications, this scientific field has an essential meaning for humanity and will continue to develop. In this case, the primary competitors are Prokarium and Oxford Genetics whose main aim is to establish biotechnology solutions for companies (Kirk 2018). Therefore, the new model of C-H synthesis has the potential for being applied in several industries.

In general, the process of customer validation should consist of identifying whether the discussed industries can benefit from the proposed solution. Therefore, it is crucial to determine if the existing fields where the proposed concept can be applied have a potential for growth and development. According to Clarke and Kitney (2016), in the UK, the industry is supported by the government through its Synthetic Biology Roadmap developed in 2011.

Therefore, several science centers are engaged in developing new technologies and models in this field. The authors state that more than fifty start-up companies were created and are currently working on new products for this industry. Kirk (2018) argues that a lot of start-up companies that work on biotechnology projects, and more specifically on synthetic biology, were established in the UK. This implies that there are a lot of prospective customers that can benefit from licensing this C-C functionalization model.

A potential exists considering the number of new companies that were established in the industry that can use this technology. Besides, Kirk (2018) emphasizes that startup companies in the manufacturing of synthetic biology managed to acquire over ÂŁ620 million from investors. This indicates that the solution discussed in this paper may have a significant value to the industry. It should be noted that the field of synthetic biology is varied and does not always imply the usage of C-H; however, the company can benefit from offering its technology to this industry.

The usage of cytochrome P450 discussed by the authors provides implications for working in the industry of pharmaceuticals and more specifically discovering new ways of approaching human protein issues. These proteins are especially important because they facilitate the formation and metabolism of elements within human cells. This includes hormones and fats, which can have a significant meaning for developing medications.

As was discussed previously, rival companies already have an established approach used for C-H functionalization. State-of-the-art functionalization is described by Davies and Morton (2017, p. 936) as “metal-catalyzed intermolecular C–H insertion reactions of carbenes and nitrenes.” However, the authors argue that, in most cases, the optimization of the process is required to achieve the anticipated result of functionalization.

One aspect of this is the application of noble metals, which results in high costs for the process. Su, Cao, and Shi (2015) argue that this aspect of molecular chemistry is especially significant, and therefore advances in it are essential to many industries. It is because the process described in the paper can be used to manufacture valuable chemical elements. The most important factor is that the proposed concept uses supplementary materials that are abundant in nature, which makes the manufacturing process more convenient.

Therefore, the advantage of this company is that, currently, the synthesis of C-H bonds is limited due to the existing technology, which affects the ability of organizations to work with these bonds. Therefore, based on the fact that this technology can be patented, in the next five years, the company will be able to obtain at least 25% of the global market for the functionalization of C-H in the industries described above.

It is because the proposed technology offers many advantages and is easy to implement due to the use of materials that can be obtained. The benefit that this technology will bring to the market involves both the efficiencies of C-H functionalization and implications for further research and development. Therefore, the proposed concept will ensure that the strategies applied by biotechnology companies in a variety of industries are more cost-effective and less time-consuming.

Prospective Hurdles

Several hurdles can be identified within the process of enabling this C-C synthesis technology’s work. Firstly, filing a patent for intellectual property in the UK is both expensive and time-consuming. Moreover, in subsequent years, the company will have to invest in a PTC that allows an enterprise to claim the technology described above internationally. Secondly, funding for biotech can be limited due to the high risks associated with this industry.

Finally, commercial companies that already operate in this industry may be challenged by this discovery. As was discussed previously in the paper, currently, many companies within the UK have sufficient funding from investors or support from the government that may lose profit due to the application of this technology. This is especially evident because the proposed approach utilizes iron instead of widely applied noble metals in C-H functionalization.

The industries in which the proposed technology will be introduced should be examined as well to determine the validity of application and prospective obstacles. Besides, Van Reenen (2002) argues that the biotech industry is under much pressure due to economic struggles. It is connected to the past scandals and the inability of some companies to deliver proper results, which leads to additional attention from the public. Moreover, in cases of application in the pharmaceutical industry, the subsequent clinical trials can pose a risk for the company because the process of testing and delivering a new medication to the market is lengthy and complex.

Summary of the Customer Validation Process

Overall, the process of customer validation consists of identifying where the prospective clients for C-H bond functionalization can benefit from this technology. Paul, Thangaraj, and Ma (2015, p. 1209) state that “biotechnology has been a focus for scientific innovation and advance for over 30 years and a major driver for commercial interest in science.” Therefore, the concept proposed in this paper has significant market potential in different industries. Pharmaceutical companies consist of both well-established and start-up organizations that can use this cost-efficient model while the manufacturing of synthetic biology continues to grow and develop.

Conclusion

Overall, this report considers the market prospects of the strategy introduced in the article “Enzymatic Assembly of Carbon-Carbon Bonds via Iron-Catalysed sp3 C–H Functionalization.” In general, pharmaceutical, synthetic biology, and plastics industries can benefit from this approach, which is more cost-effective and time-efficient when compared to standard methods. The estimated value of the markets that can benefit from the discovery is ÂŁ61,4 billion and these industries will continue to grow.

Reference List

Anekwe, L 2015, . Web.

Clarke, L & Kitney, R 2016, ‘Synthetic biology in the UK – an outline of plans and progress’, Synthetic and Systems Biotechnology, vol. 1, no. 4, pp.243-257.

Daugulis, O, Roane, J & Tran, L 2015, ‘Bidentate, monoanionic auxiliary-directed functionalization of carbon–hydrogen bonds’, Accounts of Chemical Research, vol. 48, no. 4, pp.1053-1064.

Davies, H & Morton, D 2017, ‘Collective approach to advancing C–H functionalization’, ACS Central Science, vol. 3, no. 9, pp.936-943.

Dehns 2017, The financial realities of patent protection. Web.

2017, SMU. Web.

He, J, Hamann, L, Davies, H & Beckwith, R 2015, ‘Late-stage C–H functionalization of complex alkaloids and drug molecules via intermolecular rhodium-carbenoid insertion’, Nature Communications, vol. 6, no. 1, pp. 5943.

Kirk, D 2018, Investment fuels cutting-edge synthetic biology in the UK. Web.

Number of biopharma enterprises operating in the UK 2017. Web.

Paul, M, Thangaraj, H & Ma, J 2015, ‘Commercialization of new biotechnology: a systematic review of 16 commercial case studies in a novel manufacturing sector’, Plant Biotechnology Journal, vol. 13, no. 8, pp.1209-1220.

Sherkow, JS 2016, Choosing an IP protection regime depends on the type of company you are building. Web.

Su, B, Cao, Z & Shi, Z 2015, ‘Exploration of earth-abundant transition metals (Fe, Co, and Ni) as catalysts in unreactive chemical bond activations’, Accounts of Chemical Research, vol. 48, no. 3, pp.886-896.

2019. Web.

van Reenen, J 2002 ‘Economic issues for the UK biotechnology sector’, New Genetics and Society, vol. 21, no. 2, pp. 109-130.

Zhang, R, Chen, K, Huang, X, Wohlschlager, L, Renata, H & Arnold, F 2018, ‘Enzymatic assembly of carbon–carbon bonds via iron-catalysed sp3 C–H functionalization’, Nature, vol. 565, no. 7737, pp.67-72.

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