细胞制剂质量评价
Search documents
药品监管科学全国重点实验室课题研讨会暨细胞制剂质量评价创新中心揭牌仪式成功举行
Yang Zi Wan Bao Wang· 2025-08-28 05:17
Core Insights - The establishment of the "Cell Preparation Quality Evaluation Innovation Center" aims to enhance the quality control of cell-based therapies and address industry challenges through innovative research and collaboration [1][2][3] Group 1: Research and Development Initiatives - The "National Key Laboratory of Drug Regulatory Science" has approved a project focusing on AI-driven dynamic rapid testing methods for stem cell preparation quality control, utilizing self-developed AI technology [1] - The project "Lens-free Digital Chip Microscopy Technology and Biomedical Applications" has been recognized as one of the top ten technological advancements in the biomedicine field in Jiangsu Province for 2024 [1] Group 2: Collaboration and Strategic Goals - The Jiangsu Provincial Drug Supervision and Inspection Research Institute emphasizes the importance of collaboration in technology support, standard formulation, and platform construction for the innovation center [2] - The center aims to bridge the gaps in the "R&D-production-regulation" chain, facilitating high-quality development in the cell therapy industry to meet urgent patient needs [2][3] Group 3: Quality Assurance and Industry Standards - The focus on quality evaluation research for cell preparations is expected to fill industry gaps and provide comprehensive testing services for cell drug developers [3] - The Jiangsu Provincial Drug Supervision and Inspection Research Institute plans to enhance its technical capabilities to ensure a robust quality control system throughout the drug lifecycle [3]