Science and Products
GMP production quality management platform for cell drugs
The company has established a quality management system platform that meets GMP requirements and satisfies the characteristics of immune cell therapy products, achieving digital and informational management of production quality.Through the DMS\TMS system, a GMP system document has been established, covering management regulations for organization and personnel, plant and facilities, equipment management, materials and products, confirmation and verification, document management, production management, quality assurance, quality control, computerized systems, donor materials, etc. The medical management system controls the collection, transportation, and return of donor materials at the hospital end, while the factory end achieves full-process information management and product traceability through MES, LIMS, EMS, BMS, SCADA, ERP, and other systems, providing comprehensive assurance for the quality of products leaving the factory.DMS\TMSSystem has builtGMPSystem documents, covering management regulations for organization and personnel, plant and facilities, equipment management, materials and products, confirmation and verification, document management, production management, quality assurance, quality control, computerized systems, donor materials, etc. The medical management system controls the collection, transportation, and return of donor materials at the hospital end, while the factory end achieves full-process information management and product traceability throughMES,LIMS,EMS,BMS,SCADA,ERPand other systems to achieve full-process information management and product traceability, providing comprehensive assurance for the quality of products leaving the factory.
The company has nearly 80 core technology patents in key steps such as cell preparation. Now it has established a pipeline of 10 + genes and cell products for different cancer species, covering gene modification/non-gene modification, multi-target/single target, with target indications covering solid tumors, blood tumors, virus infection and other related diseases. Research and development progress is at the international advanced level. The company has undertaken a number of scientific research projects, such as the National 863 Project, the National Nature Fund, the Ministry of Industry and Information Technology High-quality Development Project, the Beijing Science and Technology Innovation Fund, and the National Ministry of Science and Technology Major New Drug Creation.
As of June 2024, a total of five immune cell therapy products have entered clinical trials. Core Product EAL®It is an immune cell therapy product approved to enter the Phase II clinical trial of solid tumor treatment in China, and will be included in the list of CDE breakthrough treatment varieties in September 2023, which is expected to fill the gap of immune cell therapy in the field of solid tumors in China. At the same time, with aT19, RC19D2, CAR-T-19 injection and other three approved gene-modified cell drugs into clinical trials, and the perfect combination of two gene-modified product TCR-T-CMV and TCR-T-EBV for infection after hematopoietic stem cell transplantation, a rich research and development layout of immune cell therapy product pipelines in the field of hematological tumors has been formed.
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