Development of Manufacturing Technology of Cell Therapy Medicinal Products and Regulatory Challenges
In recent years,the number of applications for cell therapy medicinal products,particularly those involving chimeric antigen receptor T cell(CAR-T)therapies,has surged significantly in China.Several products have been approved,providing effective treatment options for relapsed or refractory diseases such as hematological malignancies.Despite these advancements,the high production costs and prices limit the clinical accessibility of these therapies.To better control costs,enhance drug safety,solve supply chain challenges,and achieve broader patient access,research and development(R&D)institutions are exploring innovative methods.Nevertheless,the manufacturing processes of cell therapy products are intricate,and the understanding of these processes and their quality is still evolving among stakeholders and regulators.Continuous optimization of manufacturing processes and the application of innovative technologies pose significant challenges to both R&D and regulation.This paper discusses the progress of innovative manufacturing technologies in the context of CAR-T cell therapies and analyzes the challenges to R&D of cell therapy medicinal products based on current regulatory frameworks and evaluation experiences.These insights aim to provide a reference for the R&D and regulatory policy formulation of cell therapy medicinal products.
万方数据
维普
