(1) Preclinical research
Cell Valley can provide an integrated preclinical cellular immunotherapy service platform that includes antibody screening, virus vector construction,
CAR-T/CAR-NK/CAR-M cell preparation, in vitro activity verification of
CAR-T/CAR-NK/CAR-M cells, and in vivo activity verification of
CAR-T/CAR-NK/CAR-M cells. Screen
CAR-T/CAR-NK/CAR-M cell products with significant therapeutic effects in vivo, and directly prepare
CAR-T/CAR-NK/CAR-M cells based on retroviruses. According to the customized needs of cell therapy new drug companies, Cell Valley can also provide clinical and commercial production supporting services such as technology transfer consulting and process characterization.
(2) IIT Research Service/IIT Service
The Cell Valley IIT service is mainly aimed at non registered clinical trials led by medical institutions or researchers, with individuals or groups as the research objects, and the main purpose is to analyze the efficacy, safety, and other indicators of cell therapy products in patients. This type of research is usually reviewed by the initiator's organizational ethics, and cell drugs are provided by the cell valley for clinical trials. Cell Valley can also assist initiators in conducting project review, process management, quality management, contract management, conclusion management, and archive management for clinical trials.
(3) IND research service/IND service
① IND-CMC service
IND-CMC services mainly include pilot scale amplification based on laboratory scale processes, and the production of pilot samples for clinical application of new drugs in the GMP workshop. Cell Valley can provide IND-CMC services for clinical trial applications of new cell therapy drugs in China, the United States, Europe, Australia, and other regions. On the basis of completing laboratory scale process development and testing method development, process amplification testing is carried out in the GMP workshop, and 3-4 batches of IND application samples are produced and quality control release is completed. The company also provides customers with the complete set of materials and samples required for IND application of new cell therapy drugs.
② Clinical I&II&III Trial Services/IND Service
The GMP production platform of Cell Valley strictly follows the regulatory requirements of multiple countries, and conducts the production and quality control of clinical samples for cell therapy according to GMP standards. The production process complies with the regulatory requirements of GMP production and new drug application requirements. The platform focuses on large-scale and highly flexible one-time production technology, equipped with multi brand international mainstream equipment, to complete the production of clinical grade plasmids, viruses, and cell therapy products. The produced clinical grade plasmids, viruses, and cell therapies meet the product consistency requirements of clinical I&II&III cell therapy trials. Cell Valley can also assist cell therapy new drug companies in applying for IND projects, including application document writing, pre IND meeting assistance, post clinical meeting assistance, and review and discussion assistance. At the same time, Cell Valley has reached a strategic partnership with the "Intervention and Cell Therapy Center/Phase I Clinical Trial Center" of Peking University Shenzhen Hospital, which can assist cell therapy new drug companies in accelerating and ensuring the implementation of Phase I clinical trials.