T淋巴细胞在人体免疫系统中扮演重要的角色,利用特定类型T细胞的固有功能来对抗疾病已成为革命性的技术手段。常见的T cell-based therapy有CAR-T疗法、TCR-T疗法等,这些疗法在患者中产生了持久且有效的临床反应。然而,T细胞的体外大量快速扩增仍是这一领域最大的挑战之一。
T细胞培养基作为T细胞体外培养关键的试剂,其可通过模拟体内微环境,使得分离后的T细胞在体外环境正常扩增,并维持其固有结构和功能。为了保证免疫细胞治疗产品的安全性和质量,国家药品监督管理局药品审评中心在2020年9月30日发布的《免疫细胞治疗产品药学研究与评价技术指导原则(征求意见稿)》中指出:尽可能选择GMP级别、无血清、无动物源性、成分确定的培养基。对于细胞治疗领域的客户来说,培养基除需满足以上特点外,还需要有良好的性能来支持T细胞的体外大量快速扩增。
ACROBiosystems百普赛斯专注于支持免疫细胞疗法相关研究和工艺生产,自主研发的CelThera™ GMP级T细胞培养基采用创新的化学限定配方,不含血清和动物源成分,专注于提升T细胞培养的稳定性与可控性,结合细胞因子的完美支持,助力高效T细胞扩增,满足临床及商业化规模的严格要求。我们通过在多种规模化体系下的全面验证,包括6孔板、T225培养瓶和3L体系,展现了其在不同生产场景中的卓越适用性,为全球T细胞疗法的商业化生产提供了科学依据和强有力的技术支持。
化学成分限定、无动物源、高批间一致性;
无需血清或血替添加;
达到CD4+/CD8+=1:1的时间更短;
更快促进细胞中TN/SCM比例增加;
促进T细胞、CAR-T细胞、TCR-T、外周血淋巴细胞(PBL)等T源细胞的快速扩增,且可维持良好的细胞活率;
支持从临床前开发到生产的规模放大;
提供完整申报支持文档、全套方法学验证报告等文件,已完成FDA DMF备案。
6孔板体系下的PBMC来源T细胞培养方案
Human PBMCs were cultured with GMP Human IL-2 Protein (ACROBiosystems, Cat. No. GMP-L02H14) with CelThera™ GMP T Cell Expansion Medium (ACROBiosystems, Cat. No. GMP-CM3101) or T cell culture medium (Competitor L +2.5% SR) for two weeks. The result shows that CelThera™ GMP T Cell Expansion Medium (ACROBiosystems) can be comparable with the Competitor L +2.5% SR. Notably, the cells exhibits better expansion in CelThera™ GMP T Cell Expansion Medium (ACROBiosystems, Cat. No. GMP-CM3101).
Human PBMCs were cultured with CelThera™ GMP T Cell Expansion Medium (ACROBiosystems, Cat. No. GMP-CM3101) or T cell culture medium (Competitor L +2.5% SR) for two weeks. The result shows that CelThera™ GMP T Cell Expansion Medium (ACROBiosystems) can be comparable with the Competitor L +2.5% SR.
T225瓶体系下的PBMC来源T细胞培养方案
Human PBMCs were cultured with GMP Human IL-2 Protein (ACROBiosystems, Cat. No. GMP-L02H14) with CelThera™ GMP T Cell Expansion Medium (ACROBiosystems, Cat. No. GMP-CM3101 & GMP-CM3101-1) for two weeks. The result shows that CelThera™ GMP T Cell Expansion Medium with GMP Human IL-2 Protein can promote the expansion of these cells with a reasonable cell viability.
Human PBMCs were cultured with GMP Human IL-2 Protein (ACROBiosystems, Cat. No. GMP-L02H14) with CelThera™ GMP T Cell Expansion Medium (ACROBiosystems, Cat. No. GMP-CM3101 & GMP-CM3101-1) for two weeks. The result shows that CelThera™ GMP T Cell Expansion Medium with GMP Human IL-2 Protein can increase the percentage of the CD3+ cells. With the post-culture time, the proportion of CD4 cells gradually decreased, and the proportion of CD8 cells gradually increased.
3L体系下的PBMC来源T细胞培养方案
Human PBMCs were activated using 0.2 µg/mL GMP Monoclonal Anti-Human CD3 Antibody (OKT3) (ACROBiosystems, Cat. No. GMP-MC0323) and 1 µg/mL GMP Monoclonal Anti-Human CD28 Antibody (ACROBiosystems, Cat. No. GMP-MC2824), cultured with CelThera™ GMP T Cell Expansion culture medium (ACROBiosystems, Cat. No. GMP-CM3101) supplemented with 500 IU/mL GMP Human IL-2 Protein (ACROBiosystems, Cat. No. GMP-L02H14) for two weeks. The results showed that GMP human IL-2 protein, GMP monoclonal anti-human CD3 antibody (OKT3), GMP monoclonal anti-human CD28 antibody and CelThrea™ GMP T cell expansion medium could be used to culture T cells in a 3L large system. It can efficiently expand cells with high viability.
Human CD3 Antibody (OKT3) (ACROBiosystems, Cat. No. GMP-MC0323) and 1 µg/mL GMP Monoclonal Anti-Human CD28 Antibody (ACROBiosystems, Cat. No. GMP-MC2824) and cultured in CelThera™ GMP T Cell Expansion culture medium (ACROBiosystems, Cat. No. GMP-CM3101) supplemented with 500 IU/mL GMP Human IL-2 Protein (ACROBiosystems, Cat. No. GMP-L02H14) for two weeks. The result shows that percentage of CD3+ cells in living cells is above 99%. At the end of the culture process, the majority memory phenotype of T cells is TN/SCM, followed by TCM, which means that the cell harvest will have a promising effect, such as sustained proliferation, prolonged survival, and so on.
ACROBiosystems百普赛斯生物科技股份有限公司
北京:010-53681107
上海:021-50850665
邮箱:(产品订购)order.cn@acrobiosystems.com
邮箱:(技术支持)tech.cn@acrobiosystems.com
邮箱:(廉洁合规)lianjie@acrobiosystems.com
地址:北京经济技术开发区宏达北路8号5号楼4层