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Becoming a Creator: How to Harness the Divine Power of Synthetic Biology

Chen Minlei | author

Li Tuo | edit

Hull hard technology | mastermind

Humans once used to describe the nature that shaped life as "creator," but now, with the development of a new technology, we have acquired at least some of the abilities of this role.

This superpower is the result of the further extension of the "Central Law.". It includes a combination of prestigious Nobel Prize-level biotechnologies that have undergone decades of advancement, such as gene sequencing and gene editing techniques. To this day, people use the term "synthetic biology" to generalize it.

In fact, if 2000 is used as the first year of synthetic biology, this "not too fresh" concept has gone through more than two decades. In the past, synthetic biology was not very well known, and people did not pay attention to it until the new crown epidemic.

With the blessing of a new generation of revolutionary biotechnology, we have been able to accelerate the development of mRNA vaccines during the epidemic, and under relatively relaxed regulation, many cutting-edge therapies in the medical and health field, such as the recent high-profile swine heart transplant, have also been put into practice.

In this article, Fruit Shell Hard Technology will focus on this big picture of the industry that cannot be missed in five chapters:

What synthetic biology is

Synthetic Biology Industry Chain

Areas of synthetic biology applications

How to analyze a synthetic biotechnology company

Future risk management

What we currently call synthetic biology has the characteristics of multidisciplinary intersection, covers a wide variety of methodologies, and does not have a strict definition. But in general, synthetic biology aims to study life in the sense of "engineering science", enabling humans to design, modify, and even directly create biological systems with specific functions through engineering methods [8].

The "essence of engineering" is the most important feature of synthetic biology - under the guidance of artificial design, using the "bottom-up" principle of forward engineering, from the systematic characterization of biological macromolecules with catalytic regulation and other functions in nature, making them standardized "elements", to the creation of new biological components such as "modules" and "circuits" and cell "chassis", the construction of artificial life systems with various uses [1]. At the same time, this "construction" is extremely purposeful, requiring "what humans want, synthetic organisms must produce." Zhao Guoping, an academician of the Chinese Academy of Sciences, explained: "The most important task of synthetic biology is to design corresponding 'products' according to people's needs. ”[2]

We need to make it clear that synthetic biology is widely used in healthcare, agriculture, chemical industry, and other industries — but it is an emerging field of research in itself, not strictly speaking. This article will focus on the application of synthetic biotechnology in the industry, will not be too involved in the field of scientific research, and will not introduce too many technical details.

Becoming a Creator: How to Harness the Divine Power of Synthetic Biology

Some examples of synthetic biology applications Image source丨 Head Leopard Research Institute[3]

The basic manufacturing steps of synthetic biology products can be abstractly summarized as three links at the input end and the front end and the back end. The front end of the chassis cells (strains) transformation, which is also the most core part of the chain; the back end is through the fermentation process to achieve biological production, including fermentation, isolation and purification, modified synthesis and product development applications and other steps; the input end is the various raw materials required for artificial bacterial activities, such as glucose and other substances.

Becoming a Creator: How to Harness the Divine Power of Synthetic Biology

Manufacturing steps of synthetic biology products, source丨Tianfeng Securities[4]

Becoming a Creator: How to Harness the Divine Power of Synthetic Biology

Synthetic biology involves a huge variety of industries, technology and industry landing are highly diversified, and the development chain is long, but in general, it can be roughly divided into upstream and downstream two parts. Upstream is enabling technologies, including DNA/RNA synthesis, sequencing, and omics, while downstream is companies that develop and provide services or products using synthetic biotechnology, which are true industry players.

upstream

Emerging disruptive enabling technologies, particularly the core of next-generation gene sequencing, gene editing, and DNA synthesis, have brought the industry extremely powerful research and production tools, as well as significant improvements in the cost side, which are key factors in the rapid development of synthetic biology in recent years.

Enabling technology: Enabling technology is not strictly defined, and its connotation is determined by the goals of technological innovation. From the perspective of the technological innovation chain, enabling technology is between basic research and product development, which belongs to the category of applied research, and its mission is to promote the realization of product development and industrialization in the downstream of the innovation chain through the innovation of enabling technology.

The first is gene sequencing technology. Today's second-generation gene sequencing methods have been continuously optimized, and the efficiency has risen significantly and the cost has been rapidly reduced (the third generation of technology is not mature and cannot be applied on a large scale). McKinsey shows that the cost of DNA sequencing is falling faster than Moore's Law: in 2003, it cost nearly $3 billion to map human genes; by 2019, that number was less than $1,000, and it is expected to fall further into the $100 range in the next decade or even less.[5]

Becoming a Creator: How to Harness the Divine Power of Synthetic Biology

Genome editing technology refers to an important tool that can modify the genome in a targeted manner by editing or modifying the target gene. Since synthetic biology has critical requirements for the synthesis, assembly and editing of genetic material such as DNA, powerful gene editing technology is also an important prerequisite for the overall development of the synthetic biology industry.

Gene editing technology is divided into three generations, namely ZFN, TALEN and CRISPR/Cas 9. The first two generations of technology use protein-DNA recognition mode, resulting in high specificity of the cutting site, the inability to choose the cutting site at will, and the defects of difficult construction and easy off-target, or cumbersome operation, respectively.

CRISPR/Cas9: Clustered Regularly Interspaced Short Palindromic Repeats is a repetitive sequence within the genome of prokaryotes, an acquired immune mode in most bacteria and archaea. Cas 9 refers to a CRISPR-associated protein ( cas ) that acts as a "molecular scissors" to cut DNA at a location specified by the guide RNA. The 2020 Nobel Prize in Chemistry was awarded to the scientists who contributed to this discovery.

Becoming a Creator: How to Harness the Divine Power of Synthetic Biology

Compared with its predecessors, CRISPR/Cas9 adopts the recognition mode of RNA-DNA, and the selection of cutting sites is more extensive, and the operation is simple, the cycle is short, the cost is low, and the regulation methods are diverse. With these advantages, CRISPR/Cas9 has become the most widely used genome editing tool.

Becoming a Creator: How to Harness the Divine Power of Synthetic Biology

Technologies for large-scale genomic DNA design and synthesis are fundamental to transforming cells or creating artificial life. The early column synthesis is not only costly, but also relatively low in throughput, which cannot support the rapid development of the synthetic biological industry. However, the subsequent chip synthesis technology and ultra-high-throughput chip synthesis technology have been able to achieve large-scale high-throughput synthesis while saving reagents, significantly improving the efficiency of gene synthesis, and the cost is only one-thousandth to one-hundredth of the old column synthesis technology, but there are still strict requirements for the synthesis process, which will produce defects such as polluting organic chemical waste [6]. The latest generation of enzymatic synthesis technology has the advantages of mild conditions of action, high synthesis accuracy, and few by-products, which have great potential but are still in the early stages and not mature enough in comparison.

Becoming a Creator: How to Harness the Divine Power of Synthetic Biology

High throughput: Refers to techniques that can detect multiple samples at once or perform multiple tests on the same sample.

Primer: Refers to a large molecule with a specific nucleotide sequence and can stimulate synthesis at the beginning of nucleotide polymerization, and is connected with the reactant in the form of hydrogen bonds, such a molecule is called a primer. Artificially designed primers in vitro are widely used for polymerase chain reaction, sequencing, and probe synthesis.

downstream

Due to the wide coverage of synthetic biology in the industry, industrial chain companies have also shown highly diversified characteristics, which can be divided into two categories: platform type and product type. Platform companies pay more attention to the transformation of strains, committed to modularization and generalization; product companies mainly focus on fermentation and follow-up links, aiming to achieve large-scale production, as well as solve follow-up sales channels, establish business models and other more specific landing problems.

Becoming a Creator: How to Harness the Divine Power of Synthetic Biology

Examples of different types of synthetic biology companies Image source丨 Fruit Shell Hard Technology[7]

There is no distinction between these two types of companies. From the perspective of industry, platform companies mainly provide major technical support, while product companies launch products and solve key commercialization problems; from the perspective of investment, product-oriented enterprises with large-scale production capacity have stronger commercialization capabilities and higher certainty in the short and medium term; and platform companies are related to the long-term development capabilities of the entire industry, and need to have strong enough research and development capabilities to continuously meet the continuous iteration of product demand.

It is worth mentioning that there is no absolute boundary between these two types of companies and can be converted into each other. Platform-based companies can also develop corresponding products with their own technology; product-based companies can also go back and develop technology platforms. For example, the well-known synthetic biologists Amyris and Zymergen are both platform companies, but also launch products (stories about these two companies will be told below).

The reason why synthetic biology has become so popular in recent years is because people think it has the potential to comprehensively transform and upgrade many contemporary industries, and some more optimistic views even call it a "revolutionary" upgrade. Useful biotechnology is once again engaged in the industrial revolution.

Becoming a Creator: How to Harness the Divine Power of Synthetic Biology

Some synthetic biology landing products; Source: Head Leopard Institute[3]

In the field of medical and health

Medical health is the most intensive field of synthetic biology, and there are two main paths: one is to design and modify microorganisms, so that microorganisms can produce a certain drug molecule, or as an active drug itself, to achieve the function of treating diseases; the other is based on the engineering thinking and design concept of synthetic biology, the mammalian cells are modified to have corresponding functions, such as organ transplantation, cell therapy and vaccine production [8].

Relying on the new cellular metabolic pathway designed by synthetic biotechnology, pharmaceutical products can be synthesized through microbial cells, using raw materials such as cheap sugars, thereby reducing the production cost of pharmaceutical products, or mass-producing some complex small organic molecules that are difficult to produce under traditional chemical preparation processes. In terms of therapeutic measures, synthetic biology can artificially design and construct appropriate therapeutic gene circuits according to different diseases and pathogenic mechanisms, implant them into the human body with the assistance of the carrier, and realize the cure of the disease by correcting the circuits with functional defects of the body.

The modification of mammalian cells has just recently had a sensational practical application, that is, transplanting pig hearts for patients. Organ provider, Revivicor, is using CRISPR technology to develop pigs as a viable source of human organ transplantation. Although the patient has passed away two months after the operation, the surgery itself has shown the world the great possibilities of synthetic biotechnology in the field of organ transplantation.

Industrial chemicals

This area is also promising, using synthetic biotechnology to develop biological systems as new tools to produce upstream chemicals needed by industry and to replace traditional chemical industry products.

For example, optimize or create new and efficient production strains to produce degradable plastic polyhydroxy fatty acids (PHA) to replace traditional non-degradable polyvinyl chloride (PVC), polyethylene terephthalate (PET) and polypropylene (PP) and other materials.

Bioenergy

As the name suggests, synthetic biotechnology is also considered to have the potential to replace traditional fossil fuels. Biohydrogen is a research direction that has attracted much attention, and scholars at Virginia Tech in the United States have formed a new unnatural catalytic system of 13 known enzymes, so that starch and water can produce hydrogen under mild conditions, and then generate electricity through fuel cells [9]. There are also researchers who have used technology to increase ethanol production, or designed and constructed E. coli capable of producing biodiesel. [10]

Food & Agriculture

Similar to GMOs, which have been applied so far, synthetic biology can also increase yields by improving crops, such as using microbial or metabolic engineering to reduce fertilizer use and reshape metabolic pathways, or improving crops' resistance to insect pests and diseases, and even improving the nutritional value of agricultural products, thereby increasing the added value of products.

In the case of Joyn Bio, a joint venture between Bayer and Ginkgo Bioworks, synthetic biotechnology is used to enhance the ability of microbes to provide nitrogen nutrients to food crops to reduce the use of fertilizers. [8]

The application of synthetic biotechnology in the food field is easier to understand, that is, the replacement of traditional planting/animal husbandry/fishery with new synthetic foods, under ideal circumstances, whether it is cost, environmental pollution, production efficiency or nutritional value, taste will be greatly improved, and it is considered to have a very positive significance in solving the global shortage caused by population growth.

At present, artificial meat, which also has a certain degree of heat in the capital market, is a direct product of this concept - decomposing the components of animal meat and producing it from other sources such as plants and microorganisms, followed by protein meat in proportion to the composition, or cultivated meat that produces meat products in large quantities in vitro by culturing animal cells, both of which belong to this category.

In addition to the above specific areas, synthetic biology as a whole is also very much in line with the concept of "green economy", which is highly related to sustainable economic concepts such as carbon neutrality and ESG, which have been very hot in recent years, and is also a driving factor driving industry attention. This is mainly because:

Most of the raw materials for bio-based production are starch, glucose, etc., all of which are renewable resources, which are obviously superior to non-renewable traditional fossil raw materials in the concept of sustainable development;

Most of the reaction steps of the biological method are carried out under the action of microorganisms or enzymes, and the reaction conditions are gentler and the process is simpler. For substances involved in the metabolism of chassis cells, cells can be modified by synthetic biology techniques to meet the requirements of industrialization;

Synthetic biology can allow microorganisms to participate in more waste treatment through modification, and bio-based plastics are thermoplastic materials, easy to recycle, partially easy to degrade, and generally look less environmental burden;

Synthetic biology can complement existing chemical industries, especially for certain products that are no longer approved due to carbon neutral orientation and whose capacity can no longer be expanded (e.g., petrochemical production of succinic acid[11])

From the perspective of market size, according to CB Insights data, the global synthetic biology market size was $5.319 billion in 2019, and it is expected to achieve $18.885 billion in 2024, and the five-year compound annual growth rate (CAGR) is expected to reach a high level of 28.8%. Healthcare is the largest segment and is expected to grow from $1.7 billion in 2017 to $5 billion in 2024, with a market share of 26.6%. [4]

Among other segments, food and beverage and agriculture are the two fastest growing markets expected, with market sizes expected to reach $2.575 billion and $2.233 billion, respectively. [3]

Becoming a Creator: How to Harness the Divine Power of Synthetic Biology

Source丨Tianfeng Securities[4]

How to analyze a synthetic biology company

Synthetic biology technology Chunjiang Plumbing, the most prophet of the capital market.

According to the data, the scale of synthetic biology financing reached $7.8 billion in 2020, an increase of 150% year-on-year, but this data directly doubled to $15 billion in the first three quarters of 2021. In the third quarter of 2021 alone, global synthetic biology-related corporate funding amounted to $6.1 billion. [4]

Becoming a Creator: How to Harness the Divine Power of Synthetic Biology

By sector, the healthcare sector is the hottest in the primary market, with a financing scale much larger than other industries, with financing reaching $6.7 billion as of the first three quarters of 2021; in the Q3 quarter alone, there were 28 transactions totaling $2.7 billion in financing for related synthetic biology companies in the medical field. Food and nutrition, bioengineering and agriculture also have good attention. [4]

Becoming a Creator: How to Harness the Divine Power of Synthetic Biology

The mushrooming startups have posed a question for investors: How to analyze a synthetic biology company?

It is always difficult to understand cutting-edge technology, and the characteristics of biotechnology and organic chemistry make the threshold of understanding higher. But we also have a relatively reliable methodology: starting with the most basic laws of business.

No matter which technical route a synthetic biology company chooses, how complex and advanced it is, it will eventually achieve commercialization. Then it has to answer at least four basic questions: Will the product sell? Can it scale? Is it the optimal solution? And the most basic, the company's business science?

Whether the product selection is reasonable

Any synthetic biology company, whether product-based or platform-based, needs to answer one of the most basic questions: Can the product/service find a market?

Synthetic biology product development can not be achieved overnight, from project establishment to verification to final mass production, it takes time and money, and wrong decisions are likely to lead to upfront investment. Therefore, "what products to take into the market" is a matter that must be considered, if you want to have a relatively stable business prospects and long-term development potential, in general, the products provided by the company are either in high demand or hard enough.

The demand is large enough, that is, the downstream consumption of the raw material is huge, such as n-butanol, polyamide (n-nylon) and other products. For such products, as long as the company can prepare on a large scale through synthetic biotechnology within a reasonable cost range, it is unlikely that there will be insufficient demand and cannot be sold, and it is relatively simple to open up the market.

The demand is hard enough, that is, the product demand can not be too large, but it is at least a rigid demand. Such as Januvia (also known as sigliglitin or jia sugar vitamin), which is a very large amount of hypoglycemic prescription drugs, although the demand is not as good as bulk industrial raw materials, but it is very fixed, and the traditional chemical preparation method is not easy to synthesize, which provides a natural market space for synthetic biotechnology. Other areas with high added value, such as indispensable complex organic compounds, or CAR-T and broader immunotherapy, are also suitable for synthetic biologics companies.

Domestic Cathay Bio is a relatively successful selection of enterprises. Its main bio-based long-chain dibasic acids (mainly used in high-performance long-chain polyamides, fragrances, hot melt adhesives, lubricants, cold-resistant plasticizers, powder coatings) have successfully supported the overall business, and past data show that the company has achieved profitability of more than 100 million yuan at least in 2016 and continues to this day. Although the production process of Cathay Biotech may not be very advanced, and there is a problem of product simplification, at least the commercial landing is quite successful.

In turn, Zymergen, which was listed through SPAC (a means similar to backdoor listing), was quite popular in the capital market at the beginning, but then the negative news intensified, and it was a typical company with problems with the selection.

Zymergen's core product, Hyaline, a polyimide film that mainly targets the flexible screen market, has encountered major problems in the commercialization process. Facts have proved that no matter how hot the discussion was a few years ago, the current commercial value of the flexible screen is still very unclear, the heat of the folding screen mobile phone in the 3C market is not high, and it is difficult for the company to compete with DuPont, which also produces polyimides, and the product promotion is hugely difficult to open the downstream market.

However, the company has invested a large amount of money in the early stage, burning nearly $480 million in 2019 and 2020 alone, and as a result, it took a lot of effort to launch a product that is not in strong demand, may monopolize the global market and cannot support the company's performance, and also leads to its own financial situation is extremely bad, high debt and limited repayment ability, which is undoubtedly a huge failure in business.

In response to the failure, Zymergen's stock price slashed 76.31% on the day of the "thunderstorm" on August 4, 2021, and has since collapsed, after a slight rebound, it has fallen to this day - incidentally, Cathie Wood, a well-known fund manager who has bottomed out the day after the thunderstorm.

Becoming a Creator: How to Harness the Divine Power of Synthetic Biology

Zymergen pinned the opportunity to open the market on a product whose market prospects were not clear enough, the demand was not fixed enough, and the decision to commercialize it was made, and there were decision-making errors in post-analysis. The company pays too much attention to the innovation of the technology itself, but does not fully consider the actual needs of the market, as well as the practical problems that may be in the process of specific commercialization, and the preference of the capital market for the field of biotechnology in 2021 can boost the company's listing, but it cannot replace the product to participate in the market competition, Zymergen will fall into the current predicament is not unexpected.

Of course, it is also too harsh to require startups to accurately meet the key needs of the market at an early stage. It is difficult to avoid the failure of product selection, but the company still needs to pay close attention to market trends and make timely adjustments in combination with its own research and development progress to avoid risks on the development route. This is also a key capability for investors that should be paid more attention to.

Whether the process can be scaled up

This standard is cliché, but crucial. Many examples show that synthetic biology techniques are not particularly easy to go from laboratory to large-scale production, at least much more complex than traditional industrial production.

Therefore, to measure the development of a synthetic biology company, it is necessary to pay close attention to the scale results of its products after leaving the laboratory stage.

This brings us to Amyris. Amyris is an industry pioneer founded in 2003 and listed in 2010 to get involved in synthetic biotechnology. Its best-known achievement was the development of a yeast strain capable of producing artemisinic acid in 2005, which was successfully mass-produced a few years later (but the technology was transferred to the French pharmaceutical giant Sanofi before it was launched).

It seems that we should see a new biotech giant rise, but more than a decade later, Amyris has not even achieved profitability, but has lost huge losses year after year, revenue is also ups and downs, and the stock price can make investors look bloody.

Becoming a Creator: How to Harness the Divine Power of Synthetic Biology

This was mainly due to the fact that the companies at that time underestimated the difficulty of industrial production of products (mainly bioenergy), and the management released commitments to the market that did not meet the actual level, resulting in a huge expectation gap, and the heavy blow in the capital market further increased the difficulty of corporate financing, which in turn made development worse. However, now that the company has adjusted its product selection thinking (mainly aiming at the upstream of the consumer goods market), and the capacity problem seems to have been resolved in the fourth quarter of 2021, it can be further observed (but still in a huge loss).

Becoming a Creator: How to Harness the Divine Power of Synthetic Biology

Amelias' unrested share price since its listing

Artificial meat is a track that does not do well in the above two points.

Compared with a consumer product, the current artificial meat attaches too much added value to the slogans of "environmental protection", "carbon reduction" and "animal care", but ignores the real needs of consumers and the general law of the consumer goods market. The price is too expensive, the taste is not brilliant enough, it is difficult to please consumers, and the concept of a new generation of artificial meat and the biotechnology behind it, mainstream consumers do not care, the industry itself has not experienced sufficient market verification.

At the technical level, plant meat is relatively better, and cell meat (that is, artificial real meat) is another laboratory easy to do, mass production troublesome products. The price of cell meat at this stage can not be put into the market at all, although some companies say that they are about to achieve low-cost mass production, but the specific competitiveness, but also to really start the production line and fully verify in the bloody consumer goods market.

Artificial meat leader, Beyond Meat's recent poor performance and poor stock price trend, it is a very real reflection of the attitude of both the consumer goods market and the capital market: the company's Q4 single-quarter revenue has declined month-on-month, the annual growth data of 14% is very general, the expectation is not prominent, and the stock price naturally plummets all the way [12]. If Zymergen and Amyris's difficulties are excusable, after all, the trend research of the technology industry is relatively complex and there are many successful commercialized companies in the industry, then the artificial meat industry does not have too many excuses - overconfident in its ability to educate consumers, the judgment of the trend of the consumer goods market is too blind, the technology itself is not mature enough, and the commercialization is not successful is the normal result.

Becoming a Creator: How to Harness the Divine Power of Synthetic Biology

Is it the best process?

A production process based on advanced technology is not necessarily related to whether it can replace or upgrade existing industrial production technologies. Industrial production is not engaged in scientific research, it is necessary to take into account a series of factors such as cost, efficiency, upstream and downstream, etc. Even under the increasingly heavy pressure of "carbon neutrality", values cannot replace economic benefits as the core indicators of industrial production.

Therefore, even if large-scale production is achieved, whether to use synthetic biological methods to improve the existing production process needs to be combined with the actual situation.

This brings us back to Amyris. The merits of synthetic artemisinin do make it unique in the capital market, but the problem is that synthetic synthesis is not the optimal process for the preparation of artemisinin (although this is not directly related to the company's subsequent dilemma).

Today, the traditional plantation model is still the best way to produce artemisinin, and the process of extracting the required substances from natural plants can completely control the price at a very low level. The technological advancement of synthetic organisms has not been converted into price advantages, which makes its product competitiveness extremely limited and difficult to obtain orders from downstream customers.

This is equivalent to staging a plantation "millet plus rifle" that knocks down the "aircraft cannon" of modern biotechnology.

In general, even if a synthetic biology company selects the right products and can achieve large-scale production, it must still have a large enough advantage over the traditional manufacturing industry in the actual landing process, otherwise it will be difficult to truly convert potential customers - the transformation of the existing supply chain is the cost of downstream enterprises, and the influence of traditional suppliers should not be underestimated. Commercialization is, after all, much more complicated than conducting research in the laboratory.

Whether it conforms to objective laws

Finally, and most importantly, a synthetic biology company, no matter how beautiful the story it tells, must conform to the most basic objective laws.

When a concept is extremely hot in the capital market, it is not uncommon to steal the concept, hang up the sheep's head to sell dog meat, open the mouth, and even directly start to kill pigs, and as the scope of its own coverage is relatively broad, the lack of rigorous definition of synthetic biotechnology, this risk will be more obvious.

I believe that no investor will be willing to get involved in the next hoax such as Hanxin, Hydrogen Car or Theranos. If the scientific nature of a company's technical route is in doubt, then its reliability obviously requires more detailed investigation. I believe that there is no need to repeat this point in this article, in short, adhering to a rigorous scientific attitude in a highly specialized field, not interfering with judgment by fiery concepts, and not blindly shooting because of FOMO (Fear of missing out), is the best protection from decision-making errors.

risk management

No matter how hot the synthetic biology industry is, there is still one issue that we need to be extra careful about: how to regulate the industry. Few business areas involve "creating entirely new lives," which complicates the ethical issues and regulatory frameworks that come with the commercialization of synthetic biology.

The first is basic market access criteria. What kind of products can be listed? What kind of no? Is there a need for a new evaluation system for synthetic biotechnology products? Is a new filing and approval model needed? These are directly related to the commercialization of products and services, and a reasonable regulatory mechanism can greatly promote the development of the industry, which in turn will become a shackle to access society.

Second, if released into the natural environment, living organisms or products manufactured by synthetic biotechnology will inevitably have some kind of impact, and the consequences may be large or small, including but not limited to [9]:

The communication of modified genes or DNA components of synthetic living organisms with natural organisms and their survival in nature and their ecological consequences;

The effects of other organisms in nature upon contact with the active living organism or its products;

Synthetic LMos, substitution of or inhibition or promotion of other organisms in nature through competition, interspecific relationships;

Possible impacts on geochemistry, nutrient cycling, and carbon emissions and fixed and global climate change;

Uncertain effects on other organisms caused by other unintended effects.

How to more securely protect these products from unexpected contact with the natural world, resulting in unforeseen consequences, is a topic that must be paid special attention to at both the regulatory and industrial ends, and needs to be extra careful, otherwise the impact on the industry may be immeasurable.

In the process of creating living things, it is bound to lead to certain ethical controversies, so at least from the beginning of academic research, a relatively complete ethical framework needs to be established, and the project should be submitted to the Theory Committee for detailed consideration. From the perspective of industrial development, another gene-edited baby incident in 2018 is completely unacceptable, and it is likely to cause irreversible damage from basic academic research to the final industrial landing. Therefore, proper regulation is also necessary.

Finally, there is the issue of public acceptance. "Technophobia" is not uncommon, and the public tends to have a negative attitude towards new technologies. Today, people's complex attitudes towards transgenic technology are enough to show that a new technology, especially biotechnology involving basic needs of life, will encounter very complex situations in the process of access to society, which is the situation that needs to be faced after the large-scale application of synthetic biotechnology products.

How to help the public accept new technologies, build basic trust in new technologies, and how to use regulatory frameworks and industry standards to maintain trust requires practitioners and regulators to think carefully and give feasible solutions. Only in this way can we truly establish a healthy environment that is conducive to the rapid development of the industry and serves the public with technological achievements, and promote the overall development of society.

References:

[1] Zhao Guoping: Synthetic Biology: A "Weapon" in Life Sciences(Open Book). People's Daily News. 2020.11.17 http://scitech.people.com.cn/n1/2020/1117/c1007-31933956.html

[2] Huang Haihua: After artificial bovine insulin and artificial monochrome eukaryotic cells, what will be the next "blockbuster" in Shanghai. Shangguan News. 2022.01.11 https://www.jfdaily.com/staticsg/res/html/web/newsDetail.html?id=440434&sid=11

[3] Head Leopard Research Institute: Prospects and Applications of Synthetic Biology in 2022.2022.01

[4] Tianfeng Securities: Synthetic Biology, the Future Has Come, Opening the Era of "Creation". 2021.01.09

[5] McKinsey Global Institute: The Bio Revolution. 2020.05

[6] Orient Securities: Synthetic Biology Series Report I: Future-Oriented Industries. 2021.07.30

[7] Yang Jingyi: How many steps to turn microorganisms into tools?. Fruit Shell Hard Technology. 2022.02.09 https://mp.weixin.qq.com/s/jr06jkt9aH8ikES4HbQoDw

Zeng Zhengyang, Liu Xinyu, Ma Mingju, et al. Research on development and investment and financing strategy of synthetic biology industry[J]. Integration Technology, 2021, 10(5): 104-116.

Guan Zhengjun, Wei Wei, Xu Jing: Research progress and risks of synthetic biology. China National Biodiversity Conservation Commission. 2015.06 https://cncbc.mee.gov.cn/kpzs/rsswdyx/201506/P020150616593837746632.pdf

Zhao Guoping. Synthetic Biology: Opening a New Era of Life Sciences","Convergence"[J]. Journal of Chinese Academy of Sciences, 2018, 033(011):1135-1149.

[11] China Merchants Securities: Synthetic Biology Industry Depth: Subverting Tradition, Making Use. 2021.12.07

[12] Beyond Meat:REPORTS FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS. 2022.02.24 https://investors.beyondmeat.com/news-releases/news-release-details/beyond-meatr-reports-fourth-quarter-and-full-year-2021-financial

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