关于细胞制剂产品质量研究与质量控制的一些思考

Some considerations on quality research and quality control of cell preparation products

近年来,细胞治疗成为研究热点,为肿瘤等重大和难治性疾病提供了新的治疗手段。本文针对细胞制剂产品的特点,提出细胞制剂产品质量研究和质量控制的一些思路和原则,包括生产质量管理规范、细胞制剂产品生产用原材料、制备工艺与过程控制、质量研究和质量控制等,希望通过不断完善的质量管理推进细胞制剂产品研发的健康发展。

Recently, cytotherapy has become a research hotpoint, which provide a novel therapeutic approach for tumor and other major and refractory disease. In this paper, some ideals and principles on quality research and quality control of the cell preparation products were suggested, including Good Manufacturing Practice （GMP）, raw materials for production of the cell preparation, processing technique and process control, quality research and quality control, and so on. It hopes that successful research and development of the cell preparation products were advanced through continuous improvement of quality management.