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(1) Preclinical Research:
Cell Valley provides integrated preclinical cell immunotherapy services, from antibodyscreening,viral vectorconstruction,CAR-T/CAR-NK/CAR-Mcell preparationtoCAR-T/CAR-NK/CAR-M cells. Cell therapy products with significant in vivo therapeutic effects are screened and then industrially produced. Depending on client needs,Shenzhen Cell Valleycan also provide supporting services for clinical and commercial production, such as technology transfer consulting and process characterization.

(2) IIT Research Services:
Cell Valley's IIT services primarily target non-registered clinical trials led by medical institutions or researchers, using individuals or groups as research subjects, with the main purpose of analyzing the efficacy and safety of cell therapy products in patients. These studies are typically reviewed by the initiator through ethics and other procedures, withShenzhen Cell Valleyproviding the cell drugs for clinical trials.Shenzhen Cell Valleycan also assist initiators with clinical trial project review, process management, quality management, contract management, project completion management, and record management.

(3) IND Research Services / IND Service

① IND-CMC Service
IND-CMC service mainly includes pilot-scale amplification based on laboratory-scale processes, and production of pilot-scale samples for new drug clinical trial applications in a GMP workshop.Shenzhen Cell Valleycan provide IND-CMC services for IND clinical trial applications of cell therapy new drugs in China, the United States, Europe, Australia, and other regions. Based on the completion of laboratory-scale process development and testing method development, we conduct process amplification testing in a GMP workshop, complete the production and quality control release of 3-4 batches of IND application samples, and provide customers with a complete set of materials and samples required for IND applications of cell therapy new drugs.

② Phase I & II & III Clinical Trial Services / IND Service
Shenzhen Cell Valley'sGMP production platform strictly follows the regulatory requirements of multiple countries, and conducts cell therapy clinical sample production and quality control in accordance with GMP standards. The production process complies with GMP production regulations and new drug application requirements. The platform, centered on large-scale, highly flexible, single-use production technology and equipped with mainstream international equipment from multiple brands, manufacturesclinical-grade plasmids,viralvectorsThese products meet the consistency requirements for Phase I, II, and III clinical cell therapy trials.Shenzhen Cell Valleyalso assists cell therapy drug companies with IND (Investigational New Drug) project applications, including document drafting, pre-IND meeting assistance, post-clinical meeting assistance, and review discussion assistance. Furthermore,Shenzhen Cell Valleyhas established strategic partnerships with the "Interventional and Cell Therapy Center/Phase I Clinical Trial Center" at Peking University Shenzhen Hospital and Union Shenzhen Hospital of Huazhong University of Science and Technology, enabling cell therapy drug companies to accelerate and reliably conduct Phase I clinical trials.

II. Service Cases:

Shenzhen Cell Valley , in collaboration with Peking University Shenzhen Graduate School and Huazhong University of Science and Technology Shenzhen Union Hospital, launched a joint research project on " Clinical Study of CD19-CD22 Dual-Target CAR-T Based on Retroviral Vectors ." On October 11, 2023, Cell Valley won the bid for the "GMP-Grade CAR-T Cell Preparation " project at Huazhong University of Science and Technology Shenzhen Union Hospital with an absolute advantage. Cell Valley will provide the hospital with safe, high-quality, and low-cost GMP-grade retroviral vectors and cell products, ensuring the safety and efficacy of the cell products. At the same time, Cell Valley emphasizes the close integration of scientific research and clinical practice, striving to improve treatment effects and bring research products to clinical practice.