细胞治疗产品的工艺平面与厂房设施的设计
|
摘要
细胞治疗产品的制备分为载体物质制备和CAR-T细胞终产品制备两大部分,笔者阐述了其工艺平面,如房间布局和人流、物流等要求。重点以CAR-T细胞终产品为例,介绍了其工艺设备和厂房设施的设计要求。
The preparation of cell therapy products can be usually divided into two parts including vector preparation and CAR-T cell final product preparation and its process layout requirements such as the room layout and flows of personnel and materials were described. Meanwhile, focusing on the final product of CAR-T cell as an example, the design requirements for its process equipment and plant facilities were also introduced.
The preparation of cell therapy products can be usually divided into two parts including vector preparation and CAR-T cell final product preparation and its process layout requirements such as the room layout and flows of personnel and materials were described. Meanwhile, focusing on the final product of CAR-T cell as an example, the design requirements for its process equipment and plant facilities were also introduced.
引文
[1]叶世光,李萍,梁爱斌.嵌合抗原受体T细胞治疗的研究进展[J].上海医药,2018,39(11):3-8.
[2]Eaker S,Armant M,Brandwein H,et al.Concise review:guidance in developing commercializable autologous/patientspecific cell therapy manufacturing[J].Stem Cells Transl Med,2013,2(11):871-883.
[3]Levine BL,Miskin J,Wonnacott K,et al.Global manufacturing of CAR T cell therapy[J].Mol Ther Methods Clin Dev2017,4:92-101.
[4]Alici E,Blomberg P.GMP facilities for manufacturing of advanced therapy medicinal products for clinical trials:an overview for clinical researchers[J].Curr Gene Ther,201010(6):508-515.
[2]Eaker S,Armant M,Brandwein H,et al.Concise review:guidance in developing commercializable autologous/patientspecific cell therapy manufacturing[J].Stem Cells Transl Med,2013,2(11):871-883.
[3]Levine BL,Miskin J,Wonnacott K,et al.Global manufacturing of CAR T cell therapy[J].Mol Ther Methods Clin Dev2017,4:92-101.
[4]Alici E,Blomberg P.GMP facilities for manufacturing of advanced therapy medicinal products for clinical trials:an overview for clinical researchers[J].Curr Gene Ther,201010(6):508-515.