Core Features
1. Meeting the strong demand for rapid trial-and-error, iterative optimization, and maturation during the R&D, clinical translation, and industrialization of novel cell and gene therapy technologies.
2. Providing open and responsive solutions for process development and full-lifecycle quality control of cell and gene products, while ensuring the quality assurance required for clinical trials.
3. Aligning with the development of omics platforms, biobanks, data analysis platforms, and other facilities planned by the Shanghai Clinical Research Center.
4. The team has long been engaged in explorations on the clinical translation and application of cell and gene therapies, boasting extensive and comprehensive experience in developing the general and enabling technologies for cell and gene therapy.
Subordinate Functional Platforms
1. Open-access Cell and Gene Therapy Product Process Research PlatformIn compliance with domestic and international technical guidelines and requirements, the platform implements production workflow management in line with cGMP standards and is capable of at lab-scale and pilot-scale manufacturing of cell and gene products. It carries out research on preparation process development and stability evaluation, delivering end-to-end support for relevant clinical studies.
2. Open-access Cell and Gene Therapy Product Quality Research PlatformIn accordance with domestic and international technical guidelines and requirements, a comprehensive system covering quality research, quality control, and quality assurance for cell and gene products has been established. Working in synergy with the Product Process Research Platform, it integrates multi-modal and multi-dimensional cutting-edge technologies—including imaging and omics—guided by standard testing protocols, to continuously optimize and iterate full-process quality control and traceability schemes. Through comprehensive interconnection with clinical research data systems, an open full-lifecycle database of cell and gene products is constructed.
3. Full-cycle Closed-loop Donor and Recipient Testing & Tracking Data PlatformThis platform develops health assessment protocols for donors and/or recipients associated with cell and gene therapy products. Collaborating with the Product Quality Research Platform and relying on the Information & Data Center, it builds an intelligent retrieval and integrated analysis system for medical biological information with independent intellectual property rights. It supports the construction of databases for candidate biomarkers, novel target and new drug research, multi-omics bioinformatics, as well as clinical studies and products related to cell and gene therapies, serving as a vital component of the intelligent big-data application ecosystem for cellular translational medicine.
1. R&D and Standardized Manufacturing of Novel Cell and Gene Therapies
We develop and optimize manufacturing technologies for cell and gene therapies targeting severe diseases affecting the ocular, pancreatic islet, nervous, muscular, skeletal, hematopoietic, and reproductive systems. Standardized cell production systems have been established and further refined, covering tissue-derived adult stem cells, clinical-grade embryonic stem cells, induced pluripotent stem cells and their lineage-specific differentiated cells, induced tissue stem cells, chimeric antigen receptor T (CAR-T) cells, and other cell modalities. Multiple prospective research programs focusing on advanced cell and gene manufacturing technologies are currently underway.
2. Quality Control and Preclinical Research
Based on the clinical characteristics of different diseases and their corresponding therapeutic products, we establish and continuously optimize standardized quality testing protocols and product specifications. Comprehensive quality assessment and preclinical research data are generated to support clinical trial filing and provide solid evidence for the formulation and industry-wide adoption of relevant technical standards. The in-house quality control system delivers standardized qualitative and quantitative testing solutions, provides robust technical support for clinical investigations, mitigates potential safety risks of cell products, and standardizes the clinical application and safety management of cell and gene therapeutics.
3. Support for Clinical Safety and Efficacy Evaluation
In compliance with national regulatory requirements and technical guidelines, and based on preclinical research outcomes of cell therapies, we develop standardized, reproducible clinical study protocols that adhere to ethical principles and routine clinical management workflows. The primary objective is to conduct systematic clinical safety evaluation, while the secondary objective is to accumulate standardized clinical efficacy data to support product registration and clinical application. These efforts jointly establish a scientific, rigorous, and ethically compliant pathway for the clinical translation of cell-based technologies.
4. Industrialization Exploration of Cell and Gene Therapy Products
We collaborate with leading biotechnology companies with mature proprietary CGT technological platforms and outstanding industrial advantages, as well as professional teams with rich experience in biological product clinical research. We explore full-spectrum translational and industrialization pathways, including large-scale manufacturing, high-viability cryopreservation of cell and gene products, and non-clinical application scenarios of supporting products and core CGT technologies.