关于起草《自体CAR-T免疫细胞产品生产指南(讨论稿)》的思考
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摘要
本着"服务创新驱动、保障药品质量安全"的宗旨,为支持和推动嵌合抗原受体T细胞(chimeric antigen receptor T cell,CAR-T)类免疫细胞产品的产业化进程,探讨风险控制策略,并按药品管理规范指导和规范这类产品的产业化,由上海药品审评核查中心组织发起,上海市免疫细胞治疗产业联盟的相关企业共同参与,起草编撰了《自体CAR-T免疫细胞产品生产指南(讨论稿)》。该生产指南经过业界专家的多次讨论和多方征求意见,现已形成初稿,本文就其编撰及内容作一简要介绍并提出相关思考,希望能给业界提供参考和借鉴。
To discuss the risk control strategy and guide and regulate the industrialization of chimeric antigen receptor T cell(CAR-T) immune cell production according to the specifications of drug management so as to implement the strategy for the innovation-driven development and ensure drug quality and safety and promote and support the industrialization and standardization of such pharmaceuticals. The discussion paper on the Guidelines for the Production of Autologous CAR-T Immune Cell Products was drafted and compiled by Shanghai Center for Drug Evaluation and Inspection combined with the Shanghai Alliance for Immune Cell Therapy Industries. A first draft of these production guidelines was formed after many discussions and multi-party comments by industry experts. A brief introduction to its compilation and content was given and the relevant thinking was proposed in this article.
To discuss the risk control strategy and guide and regulate the industrialization of chimeric antigen receptor T cell(CAR-T) immune cell production according to the specifications of drug management so as to implement the strategy for the innovation-driven development and ensure drug quality and safety and promote and support the industrialization and standardization of such pharmaceuticals. The discussion paper on the Guidelines for the Production of Autologous CAR-T Immune Cell Products was drafted and compiled by Shanghai Center for Drug Evaluation and Inspection combined with the Shanghai Alliance for Immune Cell Therapy Industries. A first draft of these production guidelines was formed after many discussions and multi-party comments by industry experts. A brief introduction to its compilation and content was given and the relevant thinking was proposed in this article.
引文
[1]Almabak H,Aarvak T,Vemuri MC.CAR T cell therapy:a game changer in cancer treatment[J/OL].JImmunol Res,2016,2016:5474602[2018-03-24].doi:10.1155/2016/5474602.
[2]卫生部关于印发《医疗技术临床应用管理办法》的通知[EB/OL].(2009-03-02)[2018-03-24].http://www.moh.gov.cn/mohyzs/s3585/200903/39511.shtml.
[3]国家食品药品监督管理总局药品审评中心.细胞治疗产品研究与评价技术指导原则(试行)[EB/OL].(2017-12-22)[2018-03-24].http://www.cde.org.cn/attachmentout.do?mothed=list&id=6310.
[4]Kaiser AD,Assenmacher M,Schr鰀er B,et al.Towards a commercial process for the manufacture of genetically modified T cells for therapy[J].Cancer Gene Ther,2015,22(2):72-78.
[5]药品生产质量管理规范(2010年修订)(卫生部令第79号)[EB/OL].(2011-02-12)[2018-03-24].http://www.sfda.gov.cn/WS01/CL0053/58500.html.
[6]国家食品药品监督管理总局药品审评中心.关于发布《药品生产质量管理规范(2010年修订)》无菌药品等5个附录的公告[EB/OL].(2011-02-24)[2018-03-24].http://www.cde.org.cn/attachmentout.do?mothed=list&id=4349.
[7]Eruopean Commission.Guidelines on good manufacturing practice specific to advanced therapy medicinal products[EB/OL].(2017-11-22)[2018-03-24].https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2017_11_22_guidelines_gmp_for_atmps.pdf.
[2]卫生部关于印发《医疗技术临床应用管理办法》的通知[EB/OL].(2009-03-02)[2018-03-24].http://www.moh.gov.cn/mohyzs/s3585/200903/39511.shtml.
[3]国家食品药品监督管理总局药品审评中心.细胞治疗产品研究与评价技术指导原则(试行)[EB/OL].(2017-12-22)[2018-03-24].http://www.cde.org.cn/attachmentout.do?mothed=list&id=6310.
[4]Kaiser AD,Assenmacher M,Schr鰀er B,et al.Towards a commercial process for the manufacture of genetically modified T cells for therapy[J].Cancer Gene Ther,2015,22(2):72-78.
[5]药品生产质量管理规范(2010年修订)(卫生部令第79号)[EB/OL].(2011-02-12)[2018-03-24].http://www.sfda.gov.cn/WS01/CL0053/58500.html.
[6]国家食品药品监督管理总局药品审评中心.关于发布《药品生产质量管理规范(2010年修订)》无菌药品等5个附录的公告[EB/OL].(2011-02-24)[2018-03-24].http://www.cde.org.cn/attachmentout.do?mothed=list&id=4349.
[7]Eruopean Commission.Guidelines on good manufacturing practice specific to advanced therapy medicinal products[EB/OL].(2017-11-22)[2018-03-24].https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2017_11_22_guidelines_gmp_for_atmps.pdf.