INTEGRATED
HUMAN PRACTICES
Overview

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Figure 1 : IHP mindmap

We did a lot of experiments to develop a kit that could produce antibodies in large quantities, However, when faced with the challenges of addressing consumers' pain points and bringing the product to market, we realized the limitations of working in isolation. So we embarked on our IHP journey.

First, we identified the problems through questionnaires and expert interviews. Second, we proposed our solutions in response to current market demands and consumer pain points, and in the process of communicating with experts, we continuously discovered the problem and iterated the product. Finally, commercialize the product.

Problem identification
Questionnaire one

1. The survey shows that most people believe that tumors are not easily detectable in their early stages, either based on their own life experiences or through other sources such as social media, etc. In any case, this fully reflects that tumors are difficult to detect in the early stage of the disease.

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Figure 2 : whether to detect in early stage

2. At the same time, what we found in the survey was that nearly half of the people had never encountered an example of a tumor being cured in their lives, indicating that in reality, once a tumor is contracted, many patients cannot be completely cured.

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Figure 3 whether to cure

Questionnaire two
  1. We invited several tumor patients, including those with benign and malignant tumors, and collected five responses from tumor patients. We concluded that current treatments actually have significant side effects and are too expensive.

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Figure 4 current treatment

To sum up, we can conclude that, at present, tumors are difficult to detect in the early stage,and it will rapidly turn into cancer over a long period of time. Moreover, the drugs used during treatment have significant side effects and are expensive. Once a tumor turns into cancer, the probability of complete cure is relatively low.

Stakeholder Interviews-A Pitch Meeting With Han Xin

1. Expert background

Han Xin is a professor and doctoral supervisor at the School of Medicine, Nanjing University of Chinese Medicine, and the head of the Department of Biochemistry and Molecular Biology. His core research focuses on the field of traditional Chinese medicine anti-tumor driven by cutting-edge technologies.

2. Reasons for the interview

This interview aims to explore the current deficiencies of anti-tumor antibodies.

3. Core Objectives

This interview, centering on "Construction and Application of Red Light-Induced Nanobody Production System", involves in-depth exchanges with biomedical experts.It aims to understand the current status and frontiers of anti-tumor antibody drug therapy, grasp the mainstream antibody drugs for current cancer treatment, their mechanisms of action and drug defects from the experts’ perspectives, thereby providing practical basis for the project design.

4. Interview Plan

We are committed to constructing a red-light-induced nanobody expression system and exploring its potential for application in tumor treatment. Through this interview, we hope to gain a deeper understanding of the current issues with common tumor antibodies and the frequently used targets.

5. insights

High cost and not easy to degrade. Compared with small molecule drugs, antibody drugs are more expensive and less degradable.

The effect is limited. Its target is usually limited to the cell surface so they have limited efficacy on intracellular targets.

Currently, the common targets in tumor therapy are PD-1, PD-L1, and CDL-4.

6. Reflection

Through communication, we learned about some of the current drug's Defects, so in the process of producing antibody drugs, we also took into account issues such as price and common targets.

Regarding the price, we asked existing biopharmaceutical companies on the market to know the market average price,and took into full account the cost of raw materials to set our price reasonably by communicating with technical personnel.

In terms of targets, we finally use PD-1and PDL-1.

7. Conclusion

In conclusion, the expert feedback has provided a multi-dimensional reference basis for the project. After reflection and verification, some viewpoints have been clearly incorporated into the project's optimization direction. Meanwhile, we have realized that the project still needs to solve many problems at present, such as how to reduce costs and improve the expression efficiency of Escherichia coli, as well as how to ensure the quality of each batch of products. This technology can also be combined with new technologies like gene editing and nano-drug delivery, and it may play a significant role in the treatment of more diseases in the future.

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Figure 5 Interview with Han Xin

Based on this, we asked an online representative from a biotech company who gave us some useful insights

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Figure 6

How to reduce costs

The production costs can be reduced through the following four aspects:

  1. Lowering material costs: including raw materials, auxiliary materials, packaging materials, etc. By comparing with multiple suppliers of raw and auxiliary materials, choose those with high quality and low prices to reduce production costs;
  2. Reducing labor costs;
  3. Reducing manufacturing expenses, including indirect costs incurred during the drug production process, such as equipment depreciation, maintenance, etc.;
  4. Increasing production volume to reduce costs.

How to ensure the quality of each batch of products

Complying with GMP requirements, from raw material procurement and quality control; to standardized production processes; through full-scale quality monitoring (rigorous quality inspections); as well as storage and transportation management, multiple aspects are strictly managed to ensure the quality of each batch of products.

Enhancing the expression efficiency of Escherichia coli

The composition of the culture medium, the regulation of temperature, and the concentration of inducers all have an impact on the expression efficiency of Escherichia coli.

Appropriate temperature settings can increase the growth rate of cells. Excessive temperature will cause protein aggregation and precipitation, which will affect the stability of the protein and even lead to cell death. Optimizing the expression temperature is a simple and effective method to increase the price of individual products and the quality of the protein. The composition of carbon sources, nitrogen sources and other trace elements in the culture medium directly affects the production status of Escherichia coli, and thereby influences protein expression. By adjusting the water density of the carbon source in the culture medium and controlling the growth rate of cells, the excessive growth of cells due to rapid growth can be avoided, thereby improving the expression efficiency of the target protein.

Conclusion

In conclusion, at present, most people have very little knowledge about tumors. However, tumors will not stop transforming into cancer just because of people's lack of understanding. Therefore, in addition to popularizing a large amount of knowledge related to tumors, we also need to recognize that the market urgently needs the emergence of a new technology. So, we have conceived a research project that can treat most tumor condition. But how does this project address the current market pain points, and what are its advantages? Based on these questions, we have proceeded to do the following things.

Solution
A Pitch Meeting With Wang Tao

1. Expert background

Dr. Wang Tao is a research scientist at Shanghai Pharmaceuticals (SPH), and his main research focuses on the development of antibody drugs for tumor diseases and drugs for autoimmune diseases.

2. Reasons for the interview

The interview with Dr. Wang Tao was based on a high degree of alignment between his research direction and the core issues of the project. Based on his extensive experience in the practical research and development of antibody drugs. He can provide targeted answers about the current direction of anti-tumor drug research and the technical advantages of the red light induction system compared with traditional chemical induction.

3. Core objective

The core objective of this interview is closely centered on the project phase requirements, aiming to achieve a concrete outcome through professional dialogue with Dr. Wang Tao. That is, while understanding the current research direction, to verify the technical feasibility of our approach—the red-light-induced nanobody production system.

4 Interview plan

We consulted Dr. Wang Tao about the current research and development trends of anti-tumor drugs, the research progress of red-light-induced nanobodies, the potential impacts of the technology on the environment and human body, and analyzed the core advantages and design difficulties of the red-light-induced technology, so as to clarify the scientific value of the project.

5. Insights

Current status and direction of anti-tumor drug research

Anti-tumor drug research mainly focuses on three directions: improving efficacy, reducing toxic side effects, and overcoming drug resistance.

Technical advantages and directions for optimization

Precise spatiotemporal controllability of red light. Red light is visible and controllable, and we can precisely control when red light is emitted, when it is not emitted, and the duration of red light emission.

Strong penetrability. The advantage of red light-induced nanobodies lies in their strong penetrability, which can increase the survival rate of Escherichia coli. Meanwhile, light control technology can enhance the safety and controllability of drugs.

6. Reflection

The professor pointed out that there is already a certain research foundation in China. For example, the progress made by Fudan University and the Chinese Academy of Sciences in light-controlled therapy has provided theoretical support for our technology. However, in the process of promoting clinical translation, we still need to address key issues such as efficacy, toxic side effects, drug resistance, and pay attention to potential risks. In response to these challenges, we have initially formulated solutions:

First, to improve therapeutic efficiency and sustainability through AI-assisted design and combination therapy strategies;

Second, leveraging the characteristics of red light, we will design a kit in our subsequent work that can control the start time, end time, and duration of light emission.

This conference helped us clarify the path of technological development and provided a clear direction for subsequent research, development, and transformation.

7. Conclusion

Expert feedback provides us with multidimensional references. For this technology, red light has relative advantages, but we must also be aware of its negative effects. At the same time, in response to the issues raised by experts regarding clinical, drug safety and sustainability, we interviewed another doctor, allowing him, from a doctor's perspective, to point out the right direction.

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Figure 7 Interview with Wang Tao

A Pitch Meeting With Mo Zhengbo

1. Expert background

Dr. Mo, Doctor of Traditional Chinese Medicine, Associate Chief Physician, comes from a family of Traditional Chinese Medicine practitioners.He is a young and middle-aged backbone talent and an academic inheritor registered with the National Administration of Traditional Chinese Medicine.

2. Reasons for the interview

The reason for interviewing the expert is to explore the path of clinical application of red light-induced nanobody drugs.

3. Core objective

Dr. Mo, the interviewee, provided knowledge and insights related to clinical application that are relevant to the project. Through the interview, we aimed to obtain feasibility suggestions regarding this technology in the field of synthetic biology, so as to provide professional guidance and practical direction for our project. Specifically, we needed Dr. Mo to offer new ideas and suggestions in the area of clinical application. How far is red light induction from clinical application? what directions should be considered, and what concerns are there? He was also expected to share more personal perspectives on the implementation of this technology.

4. Interview plan

We focused on the research topic "Construction and Application of Red Light-Induced Nanobody Production System" and had an in-depth conversation with Dr. Mo. In particular, we had a deeper discussion on the clinical part:

How far is red light-induced nanobody technology from the research stage to clinical application? In which aspects is it deficient? What do we need to consider from the patient's perspective?

The discussion mainly centered on the drug, examining feasibility from the perspective of drug development.

5. insights

Research on nanobody production kits

Doctors consider this a promising direction, but further clinical validation is needed. There are no similar kits available for clinical application at present, and most are still in the laboratory research stage.

The clinical application prospects of red light-induced nanobody technology

Doctor believes that the technology needs to address two core issues: safety and efficacy, especially the inhibitory effect on tumor cells and the impact on other systems of patients.What patients are most concerned about is whether the technology can significantly improve their quality of life, such as relieving pain and increasing appetite.

Drug resistance and personalized treatment

Tumor cells are prone to developing drug resistance, which can be addressed by changing drugs, reusing drugs after discontinuation, or combining drugs. Personalized treatment is particularly important in the field of oncology, where treatment plans need to be adjusted based on factors such as the patient's constitution and environment.

6. reflection

Regarding safety and efficacy. This academic consultation meeting on red-light-induced nanobody technology gave us a deeper understanding of the current situation and challenges in anti-tumor drug research and development. Although there are various ways to treat tumors at present, many drugs have significant side effects and limited effects, especially traditional chemotherapy, which is particularly harmful to the body. Although our technology is still in the research stage and has not yet been applied to the clinical stage, Dr. Mo Zhengbo believes it has potential in terms of expression efficiency and safety, and can provide a greener and more precise solution for the production of nanobodies in the future.

Regarding patients' needs. In this interview, what impressed us most was that Dr. Mo said what patients were most concerned about was not how new the technology itself was, but whether the treatment could truly relieve pain and improve the quality of life. This reminds us that medical research must be based on patients' needs and not just stay in the laboratory for biological clinical practice, blindly improving treatment effects while ignoring the real demands of patients. At the same time, Dr. Mo also pointed out that if the technology is to be promoted, it will take at least 8 to 10 years to determine the therapeutic efficacy, controllability, and safety of the drug, as well as whether the cost of purchasing the drug can support the treatment of patients. This makes us realize that from technology development to clinical application, it is a long and complex process, and therefore we need to raise sufficient funds for research and development.

Regarding personalized treatment. Through our communication with Dr. Mo, we realized that personalized treatment is particularly important. Therefore, we have decided to add a high-end product line to our offerings — a customized nanobody kit — so that we can design kits for specific tumors in specific users.

7. conclusion

Regarding safety and efficacy,this meeting gave us a deeper understanding of the original intention of our project - to enable more patients to have access to tumor treatment technologies with good efficacy, high safety, and low costs.  It has also made us aware of the practical challenges in truly implementing it. This made me feel that it was not just a technical discussion, but also a collision of sensibility and rationality, and more of an inspiration about human philosophy - why we should focus on research.

Regarding patients' needs,in general, our exploration of the red-light-induced nanobody technology not only reflects our interest in science, but also reflects our original intention to solve real medical problems. Although the technology still faces many challenges in terms of safety, clinical efficacy and widespread acceptance, we believe it has real application potential in tumor treatment.

Regarding personalized therapy, the experts' words inspired us to create a kit for patients to treat only one particular disease.

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Figure 8 Interview with Mo Zhengbo

Conclusion

After interviews with two experts, we demonstrated that our project has sufficient advantages. Although there are no similar kits available for clinical use on the market and most are still in the laboratory research stage, the experts pointed out that the feasibility and advantages of our project are quite obvious.

But at the same time, after conducting two questionnaires and interviews with three experts, we found that the questionnaire results showed that tumors are not easily detectable in the early stage and are highly likely to transform into cancer. The experts’ comments indicated that tumors were large in scope and diverse in type. Moreover, most anti-tumor drugs target malignant tumors, that is, cancer. Therefore, in terms of experimental design, our original plan was that one antibody kit could produce antibodies for the treatment of most types of tumors, but since tumors represent a broad field, it is difficult to produce drugs adapted to various tumors in this process, so we ultimately decided to take lung cancer as the entry point and focus on antibody drugs against lung cancer and other types of cancer . Eventually, the antibody drugs produced by our product will be able to treat several kinds of cancers. However, as our technology matures, we will implement a dual-product-line strategy, namely a high-end customized product line and a universal product line.

We hope to translate this reflection in the laboratory into practical impact. However, we still have some questions about achieving this translation and expanding the impact. For this reason, we are urgently need to understand matters related to translation and the issues that need attention in commercialization. Therefore, we conducted online interviews with a patient and a commercialization expert.

Commercialization
Questionnaire one

The results of the first questionnaire showed that the majority of people had never heard of our red-light-induced nanotechnology method (68.54%), but despite not having heard of it, the majority supported our new technology, indicating that there is a lot of room for development in our project.

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Figure 9 the first questionnaire

A online interview With user

At the same time, we found cancer patients on Rednote for interviews and learned that patients' demands for drugs were mainly in terms of efficacy.

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Figure 10 Interview with patient

So based on this, we will do our best to enhance the efficacy, reduce side effects and set reasonable prices in the subsequent drug production process. But regarding the specific pricing strategy, we have consulted a commercialization expert to give us some advice.

A Pitch Meeting With George Ye

1. Expert background

George Ye is a senior researcher at a private equity fund and holds financial professional certificates such as FRM and CQF. He is primarily engaged in research on macroeconomic data and industry development trends.

2. Reasons for the interview

To comprehensively evaluate the commercial prospects and implementation feasibility of the red light-induced nanobody production technology. The following analyses are conducted: The economic feasibility can be objectively evaluated by analyzing the cost structure (including equipment investment, R&D amortization and operation and maintenance expenses); by comparing traditional production methods, the technical advantages and potential bottlenecks can be identified; and by Exploring the market growth rate and investment payback period, which can help formulate a reasonable commercialization path. These analyses will provide key basis for investment decisions,selection of cooperation models, and long-term development strategies, ensuring that technological innovation can truly translate into commercial value.

3 Core Objectives

This interview focuses on the topic of "Construction and Application of the Red Light-Induced Nanobody Production System", aiming to clarify the cost structure and return on investment of the system and explore the advantages and disadvantages of cost control and the resistance to market promotion.

4. Interview Plan

The interview revolved around three aspects:

The first is insight into costs and predicaments. Understand the cost structure of the system from an enterprise perspective, including initial equipment procurement, R&D investment allocation, and later operation and maintenance.

The second is the discussion of benefits and support. Discuss in the business plan whether existing company data can be used to estimate the system's cost and sales growth rate.

The third is the development plan exchange. Explore the development path of the project in the next five years and how it fits the requirements of sustainable development.

5. insights

Cost structure of red light-induced systems

Initial equipment investment includes LED light sources, culture apparatus, chemical agents, sterile laboratory space and equipment, etc. The cost estimation methods include the comparison method and the cost method. Equipment depreciation and amortization expenses need to be taken into account, such as the depreciation of computer equipment over five years and the replacement of LED light sources every two months.

Market analysis of nanobodies

Nanobodies are mainly used in the production of anti-cancer drugs, and the market size can be estimated from the sales volume data in the annual reports of pharmaceutical companies. Market competition requires SWOT analysis to assess strengths and weaknesses, such as comparisons of technical costs and production efficiency.

Cost control and mass production

Large-scale production can reduce costs, such as expanding the area of the culture medium can lower the unit cost. It is necessary to balance the initial investment and risks,and high investment may increase the probability of loss and affect financing difficulty.

Challenges in technology commercialization

Regulatory approval is the main threshold. Environmental protection issues need to comply with national policies such as wastewater discharge standards and handling requirements for high-risk products.

Commercial cooperation models

Technology research and development as well as experimentation can increase asset investment. For example, a third-party company is responsible for the research and development of outer packaging and its sales.

Startup advice

Earn income early to reduce the risk of loss.

6. reflection

This business consulting meeting made us deeply realize that moving a technology project from idea to market is not a simple process where "success is achieved once the product is made", but involves multiple dimensions such as complex cost control, market analysis, policy risk management, and resource allocation. In the past, we focused more on the technology itself, such as whether red light induction could improve the expression efficiency of nano-antibodies, but through this exchange, for the first time, we thought from the perspective of "enterprise operations" : How do we produce? How much to produce? How much will it cost? How long will it take to recover the cost? These are the key issues that really determine whether the project can sustain itself.

According to experts’ opinions, we use the cost approach to calculate cost and price, at the same time, we use the SWOT model to assess our strengths and weaknesses. In addition, expert mentioned policy risks, environmental protection standards, and clinical approval processes during the meeting, which reminded us to pay more attention to policy information in our upcoming plans.

7. conclusion

This is a business consulting meeting on the red light-induced nanobody production system, covering a complete cost structure analysis from initial equipment investment to later operation and maintenance, as well as the market prospects and commercialization path of the project. Under the guidance of experts, we sorted out the initial investment for the kit production and conducted a preliminary estimate of the cost per box and the total budget by combining the cost approach and the comparison approach. In addition, the experts reminded us to pay attention to long-term operating expenses such as equipment depreciation, labor costs and site rent, and suggested that the cost model be gradually revised at different stages to enhance the accuracy of financial planning.

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Figure 11 Interview with George Ye

Conclusion

We formed a closed loop in project design through questionnaires, expert visits, and engagement with different stakeholders.