Fast technology iteration, high degree of innovation, and personalized customization of products
The cell therapy industry has great potential for development (innovation drives new fields ②)
Our reporter Wu Yuehui
As usual, Zhang Yingchi, a researcher at Tianjin Haihe Laboratory of Cell Ecology, came to the laboratory at 8 o'clock in the morning, changed into clean clothes, turned on the ultraviolet lamp of the biological safety cabinet, and put the culture medium in the water bath.
Half an hour later, he starts working on the cells.
Under the microscope, the cells were evenly distributed and the growth status was good.
The digested and passaged cells will be used to provide T cells with weapons to accurately kill tumor cells, and then go to the clinic, and eventually become the third generation of drugs - cell therapy drugs.
As an emerging treatment method, cell therapy has shown good results in the treatment of many diseases, especially cancer, genetic diseases, and infectious diseases.
In recent years, driven by technology, policy, and market, my country's cell therapy industry has shown a trend of vigorous development, and is expected to become a new track with great potential in the field of biomedicine.
Cell therapy, providing new options for disease treatment
Cell therapy refers to the use of bioengineering methods to obtain cells with specific functions, and through in vitro expansion, special culture, etc., to make these cells have the functions of enhancing immunity, killing pathogens and tumor cells, so as to treat certain diseases the goal of.
At present, the main cell therapy methods are immune cell therapy and stem cell therapy.
"Immune cell therapy generally refers to the targeted treatment of certain types of immune cells such as T cells and NK cells in vitro and then reinfusion into the human body to make them exhibit functions such as killing tumor cells and clearing viruses." Zhang Yingchi Said that stem cell therapy is to transplant healthy stem cells into the patient's body to repair diseased cells or rebuild normal cell tissue.
The types of stem cells commonly used in clinical practice are mainly mesenchymal stem cells, hematopoietic stem cells, and neural stem cells.
Stem cells have become one of the core areas of cell therapy research due to their multi-directional differentiation, immune regulation, and cytokine secretion functions.
In recent years, the development of genetic engineering technology has improved the targeting of cell therapy, and also promoted the development of the combination of cell therapy and gene therapy. In vitro gene therapy and vector gene therapy have emerged.
Zhang Yingchi gave an example: "Some diseases related to the hematopoietic system are generally mainly due to abnormalities in hematopoietic stem cells, and some genes in them have mutated. At this time, we can take out the patient's hematopoietic stem cells and use gene editing technology to remove the mutations." Repair the gene to a normal state, and then transplant it back. This is ex vivo gene therapy."
The emergence of cell therapy has provided a new option for the treatment of some intractable diseases that traditional therapies are ineffective.
For example, due to individual differences, it is difficult to control the optimal dosage of traditional medicines for each patient.
But in cell therapy, synthetic biology can be used to design genetic switches that control the synthesis or release of drugs.
At the same time, dynamic adjustment and prognosis monitoring can also be performed according to the patient's disease development status to obtain long-term efficacy.
Competing layout, industrial development is entering the fast lane
In the production workshop of Heyuan Biotechnology (Tianjin) Co., Ltd., a CAR-T cell therapy product is being produced.
"Cell therapy products are very different from traditional chemical drugs. After immune cells are isolated from the blood, their activity is affected by factors such as the patient's age and medication history, from cell collection, culture, genetic modification to reinfusion into the patient's body , A series of measures for clinical treatment are individualized. Therefore, one patient corresponds to one batch of products, that is, it needs to be customized." Yang Sen, a technician from Heyuan Biotechnology, said that the safety requirements are very high throughout the process. Consumables are disposable.
Compared with traditional chemical drugs, cell therapy products have the characteristics of rapid technological iteration, great innovation potential, high clinical dependence, and personalized customization of products, and many countries are competing to deploy them.
At present, the development of the global cell therapy industry is entering the fast lane.
According to statistics, by the beginning of 2022, there will be a total of 33 cell therapy products approved globally, including 12 immune cell products and 21 stem cell products.
The development time of cell therapy in my country is relatively short, but it is full of vigor.
In recent years, Beijing, Shanghai, Tianjin, Shenzhen and other places are vigorously developing the cell therapy industry.
Shanghai launched the "Shanghai Action Plan for Promoting Cell Therapy Technology Innovation and Industrial Development (2022-2024)", proposing to strive for the scale of Shanghai's cell therapy industry to reach 10 billion yuan by 2024.
Last year, Shenzhen successively issued documents to support the development of the biomedical industry, focusing on supporting the high-quality development of industrial clusters including cell therapy drugs.
In Tianjin, Binhai High-tech Zone takes the cell industry as a breakthrough to promote the high-quality construction of Beijing-Tianjin-Hebei characteristic cell valley, and forms a "one core, one belt, one circle" industrial development spatial layout system around the cell ecology Haihe Laboratory as the core of innovation power. More than 40 related companies in the cell field.
"We vigorously promote the in-depth cooperation between large institutes and high-growth enterprises." Zheng Chunlin, deputy director of the Biomedical Bureau of Tianjin Binhai High-tech Zone, said, "For example, Heyuan Biotech mainly focuses on immune cell therapy. If it starts from scratch, it will take a long time for research and development. Cycle. By cooperating with the Institute of Hematology, Chinese Academy of Medical Sciences, it can not only help enterprises quickly break through the threshold of key technologies, but also help the institute's cutting-edge technology to realize the transformation of scientific and technological achievements."
According to experts, in the field of immune cell therapy, the main field of cell therapy technology, my country has become the country with the largest number of CAR-T cell therapy clinical research in the world.
According to relevant statistics, China's cell therapy market will grow from 1.3 billion yuan in 2021 to 58.4 billion yuan in 2030, with an average annual growth rate of 53%.
It is expected that the next 10 years will be a period of rapid growth for the domestic cell therapy industry.
Standardize, support, and promote the healthy and rapid development of the industry
After more than 10 years of development, the field of cell therapy in my country has entered a stage of standardized development.
Cell therapy is considered to be a segmented track in the research and development of innovative drugs.
In the past two years, relevant competent authorities have issued a number of application guidelines related to cell therapy products to promote the review and approval of related products.
Domestic cell therapy products have obtained relatively clear guidelines from application to production.
Local governments have also continuously introduced policies to support and encourage the development and marketing of cell therapy products.
At present, research in the field of cell therapy in China has become an important force in global research and development.
At the same time, experts believe that, as an emerging industry, the cell therapy industry still faces many challenges.
Despite continuous breakthroughs in technology, it is not easy to realize the popularization of cell therapy products.
On the one hand, the industry chain for the transformation and application of cell therapy technology is not mature enough, and on the other hand, its cost is still relatively high.
Zheng Chunlin introduced: "If the relevant equipment and consumables can be localized, the cost of cell therapy products will be greatly reduced." It is understood that some equipment involved in the research and development and production of domestic cell therapy products, as well as supporting cell culture consumables, etc., are still available. Many need to be imported.
The shortage of clinical resources also restricts the clinical application of cell therapy technology.
Yan Fengying, deputy director of Tianjin Institute of Pharmaceutical Research, said: "Compared with traditional chemical drugs, cell therapy products have the characteristics of multiple sources and types of cells, and strict requirements for production and preparation processes. Therefore, it is necessary to establish research and development, production, clinical The whole chain of pre-evaluation and clinical research, standardized and standardized quality control and guarantee system. At the same time, it is necessary to set up some professional clinical research-oriented medical institutions or wards to carry out systematic and standardized clinical trials. In the basic biological characteristics of cell therapy products and On the basis of in-depth research on the mechanism of action, clinical safety and effectiveness research will be carried out."
Hui Lijian, a researcher at the Center for Excellence in Molecular Cell Science, Chinese Academy of Sciences, suggested that in the process of innovation and transformation of cell therapy, new technologies for cell therapy should be established through original innovation, and cell quality and safety evaluation, clinical research specifications and product standards should be improved to promote cell therapy. The clinical transformation application of cell therapy will promote the healthy and rapid development of the cell therapy industry.
(People's Daily)