参考资料：1. FDA官网，Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products2. NMPA官网，《基因修饰细胞治疗产品非临床研究技术指导原则（试行）》关于我们微谱于2014年正式涉足生物制品服务领域，2019年成立微谱生物科技有限公司，成为集团在生物药领域的重要战略布局。2022年公司荣...
［1］Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products, U.S. Department of Health and Human Services. Food and Drug Administration, Center for Biologics Evaluation and Research, January 2024.声明：本文内容部分源于FDA官网信息，中文翻译仅代表汉佛莱（HPC）观点，如有...
1. FDA官网,Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products 2. FDA官网,GT CMC指南
简单来说,CAR-T技术就如同给T细胞装上了GPS导航系统,通过识别并杀伤癌细胞实现治疗的目的。 接续上期的《FDA指南解读!CAR-T 细胞产品开发在CMC阶段的五大注意事项》,本期将继续围绕近期FDA正式发布的 “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products”,带来CAR-T 细胞产品...
2024年1月31日,FDA正式发布 “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products”,为CAR-T细胞产品的开发提供了化学、制造和控制(CMC)、药理学和毒理学以及肿瘤适应症(包括血液系统恶性肿瘤和实体瘤)临床研究设计的相关建议。
英文摘要: OBJECTIVE:To learn from the experience of foreign listed chimeric antigen receptor T lymphocyte (CAR-T) products in signing risk sharing agreements in medical insurance access ,so as to provide references for relevant decisions of medical insurance departments in China. METHODS :Taking 9 ...
Focused on our clients Moving CAR-T Beyond Limits With an unrelenting drive and a singular focus on cellular therapy, our team is executing on our strategy to provide a broad range of CAR products and kits for hematologic malignancies and solid tumors... ...
The quality control and nonclinical research of these products are of great significance in ensuring the safety and effectiveness of these products;however, they also present great challenges and difficulties. This article discusses the general principles of and key issues regarding the quality control ...
Aside from the cost of goods, Johnson says, Interius is aiming to address “the entire envelope of costs” associated with ex-vivo CAR products — i.e., the unforeseen and often overlooked technical costs from the hospital. “Not the least of which is sitting a patient down in a clinic ...
[2] Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products Guidance for Industry. Retrieved January 29, 2024, from https://www.fda.gov/media/156896/download [3] FDA finalizes CAR-T and gene therapy guidance, offers support for accelerated approvals. Retrieved Janu...