With the detection platform established under the leadership of the government, the safety and quality of cell therapy products can be better guaranteed.
Recently, the first third-party detection platform for cell preparations in China was built in Zhangjiang pharmaceutical Valley, and the first user has also been born – Shanghai ucardi Biomedical Technology Co., Ltd. signed a contract with Shanghai biomedical technology development center, which built the platform. This enterprise has 28 R & D pipelines of car-t and other immune cell products for tumor treatment, and the quality testing business of some pipelines and the third-party testing business in clinical trials will be handed over to the platform.
“Cell therapy technologies such as car-t cells and stem cells have developed rapidly in China, but there is a problem of ‘death as soon as you catch them, and chaos as soon as you put them away’.” Dr. Yu Lei, CEO of ucardi, said,”with the third-party testing platform established under the leadership of the government, the safety and quality of cell products developed by enterprises can be better guaranteed. It also allows hospitals to cooperate with enterprises to carry out clinical trials with one more guarantee, and ultimately benefit patients.”
Shanghai biomedical science and technology development center has also jointly formulated the group standard”technical requirements for the validation of rapid sterility test method for cell and gene therapy products” with Shanghai Pharmaceutical Industry Association, Shanghai Drug Inspection Institute and Shanghai drug examination center. Five enterprises including Keji, ucadi and Yao mingjuno have become the first batch of standard implementation units. A series of other testing standards are also being developed.
Build a platform to standardize the cell therapy industry
The cell preparation detection platform is a module of the technology functional platform of Shanghai biomedical industry. The functional platform is a new type of R & D institution, fully known as”R & D and transformation functional platform”, which has two functions:technology research and development and transformation of scientific and technological achievements. Since the 13th five year plan, the Municipal Science and Technology Commission, together with the municipal development and Reform Commission, the Municipal Commission of economy and information technology and the Municipal Bureau of finance, has promoted the construction of 15 functional platforms with the goal of improving the industrial chain and innovation chain and strengthening the function of innovation strategy sources. Located in GuoShouJing Road, Zhangjiang, the biomedical functional platform aims to meet the R & D needs of innovative drugs, benchmark international top technical teams, strategically arrange and gradually improve the”one-stop” R & D services of the whole biomedical industry chain.
The recently built cell preparation detection platform is to meet the research and development needs of innovative drugs.”In recent years, cell therapy technology represented by car-t cells and stem cells has developed rapidly in the world. In Shanghai, a large number of innovative enterprises have emerged to develop cell preparations.” Li Jizong, director of Shanghai biomedical science and technology development center, said that while this kind of technology brings hope to patients with tumors, immune system diseases, infectious diseases and other diseases, it also produces some potential safety hazards. Unlike traditional drugs, cell preparations are”live drugs”, which are mostly customized for patients, so the quality of each drug may be different, which requires corresponding standards to regulate.
The staff of the cell preparation detection platform are operating the purification instrument of the chromatography system.
How to further standardize the cell therapy industry in Shanghai? With the support of the Municipal Science and Technology Commission, the municipal development and Reform Commission, Pudong New Area and Zhangjiang Science City, Shanghai biomedical science and technology development center has incorporated the detection of cell preparations into the biomedical functional platform. This sub platform includes five clean standard cell rooms and perfect microbial testing room, flow cytometry testing room, endotoxin testing room and other units, which can meet the full set of testing requirements for the quality evaluation of cell preparations.
State owned enterprises join hands with private enterprises to form professional teams
To build a functional platform, in addition to first-class hardware equipment, there should also be a first-class technical team of the operation platform. To this end, the biomedical functional platform adopts the mode of”state-owned enterprises and private enterprises”, with the state-owned enterprise Shanghai biomedical Public Technology Service Co., Ltd., which operates the whole platform, as the main investor, and the private enterprise Shiao (Shanghai) Biomedical Technology Co., Ltd., to establish Shanghai Precision Inspection and Testing Co., Ltd., which will operate the cell preparation detection platform.
“Our technical team now has more than ten people, mainly from worldao.” Guliping, general manager of fine inspection and testing, said that since 2014, Shiao has carried out the testing of high-end biological samples and biomaterials, and is one of the earliest teams engaged in the testing of stem cells and car-t cell preparations in China. The Chinese name of car-t is”chimeric antigen receptor modified T lymphocyte”. T lymphocytes have immune activity, like the army in the human body, which is specialized in killing foreign invaders. Car is a molecular modifier that contains antibody sequences that recognize tumor antigens. Like a satellite navigation system, it enables T lymphocytes to accurately identify and destroy tumor cells.
The staff of the cell preparation testing platform are testing the killing function of car-t cells in vitro.
The T cells in car-t cell preparation are taken from the patient’s body, modified and expanded in vitro, and then reinjected into the patient’s body. In this”pharmaceutical” process, it is very important to ensure the quality and safety of cell preparations. Worldao has established advanced testing technology and specification system, so it has been selected as a partner by the functional platform.”We should be the gatekeeper of Shanghai cell therapy, and carry out quality inspection of cell therapy products developed by Shanghai enterprises or entered Shanghai hospitals for clinical research, especially the detection and evaluation of product safety, so as to ensure the safety of patients.” Guliping said.
Leave biopharmaceutical companies in Shanghai
“More than 20 years ago, Zhangjiang provided an early entrepreneurial environment for biopharmaceutical companies to settle in. Now, Zhangjiang has begun to provide platform services for mid and late product development, which can not only improve the quality and efficiency of new drug development, but also keep more biopharmaceutical companies in Shanghai.” As the founder of the first user enterprise of the cell preparation detection platform, Yu Lei sighed.
In 2015, Yu Lei founded ucardi in Zhangjiang pharmaceutical valley. In 2020, the”sscart-19 injection” developed by ucardi was approved to enter the clinical trial and is currently in the phase II clinical trial stage. Different from similar imported drugs that have been approved for marketing, this new drug for the treatment of recurrent and refractory B-lymphocyte leukemia is the fourth generation car-t product, which can be used for the car-t contraindication – central nervous system leukemia.
After signing the contract with the cell preparation testing platform, ucardi will hand over the testing business of some product pipelines to the platform for completion. In this way, a more credible third-party test report can be obtained, which is conducive to passing the drug review of the drug administration department, and can also reduce the risks faced by patients in clinical trials.
Shanghai Taijin Biotechnology Co., Ltd. is also an important partner of the functional platform. It is located in the same building as the cell preparation detection platform, which can be described as”the nearest tower wins the month first”. According to Dr. lijianliang, CEO of Taijin, the company focuses on the development of new human monoclonal antibody drugs by using its self built fully humanized transgenic mouse platform.”Antibody drugs are a mainstream type of biological drugs, and their indications include tumors, immune system diseases and infectious diseases.” Li Jianliang explained,”before the antibodies produced in mice and rabbits are used for treatment or assembled into chimeric antigen receptors, they need to be transformed by humanized protein engineering. However, the antibodies produced by our company’s all humanized transgenic mouse platform do not need to be transformed.”
Tai Jin can use the flow cytometry and other instruments of the biomedical functional platform.”It costs millions of yuan to buy a flow cytometer. Providing technical services through the platform can save us a lot of research and development costs.” Li Jianliang told reporters,”moreover, the key enterprises developing antibody drugs and cell therapy drugs are gathered in Zhangjiang. We rely on the functional platform to work, and it is very convenient to cooperate with these enterprises.”
It is understood that the biopharmaceutical functional platform has provided R & D services for a large number of enterprises, including cell therapy product preparation, biopharmaceutical pilot process development, innovative drug preparation research and development and other modules, in addition to cell preparation testing, which has become an important force to promote the development of Shanghai’s biopharmaceutical industry.