过继性T细胞疗法CMC生产工艺解决方案
可高效激活扩增T细胞,
性能优越
遵循GMP级别质量体系,无动
物源成分,更好的安全性
严格的病毒
去除步骤和检测
高稳定性
高批间一致性
Figure 1. The human T cells were stimulated with GMP ActiveMax® Human T cell Activation/Expansion CD3/CD28 Beads (Cat. No. GMP-MBS001) for 24hrs, and the activation was assessed by measuring expression of both activation markers CD25 and CD69 expression on the T cells surface by stanning with PE labeled anti-human CD25 antibody and FITC labeled anti-human CD69 antibody respectively (QC tested).
Figure 2. The human T cells were labeled with carboxy fluorescein succinimidyl ester (CFSE) and stimulated with GMP ActiveMax® Human T cell Activation/Expansion CD3/CD28 Beads (Cat. No. GMP-MBS001), and then the proliferation of the T cells was assessed with CFSE dilution assay by flow cytometry on day 5 after stimulation (QC tested).
Figure 3. Activation of the purified human T Cells. The purified human T cells were activated using Human T cell Activation/Expansion CD3/CD28 Beads, (Cat. No. GMP-MBS001) and Competitor-Beads respectively for 24 hours with CTS Optimizer Medium. Cells were fluorescently stained using PE labeled anti-human CD25 antibody and labeled FITC anti-human CD69 antibody and analyzed by flow cytometry.
CAR-T细胞
TCR-T细胞
TIL细胞
Treg细胞
T细胞在经过第一、第二信号刺激完全活化后,还有赖于多种细胞因子(IL-2、IL-7、IL-15、IL-21和TNF-α等)的作用才能进一步增殖活化。
全方位质量放行验证,
16项质量控制指标
更好的安全性(无菌,
支原体、外源病毒,
各项杂志残留检测)
药品级生产厂房
支持线上线下审计
完成FDA DMF备案
Figure 1. Cell growth curves of PBMCs cultured with IL-2. Varying concentrations of GMP IL-2 (Cat. No. GMP-L02H14) were added as a growth factor supplement to PBMCs revealing optimal cell expansion using a concentration of 500 IU/mL at Day 14.
Figure 2. Cell viability curve of PBMCs cultured with IL-2. Increasing concentrations of GMP IL-2 (Cat. No. GMP-L02H14) were added as a growth factor supplement to PBMCs showing consistent and high cell viabilities up to Day 14.
高纯度、高酶活、
高切割效率
具有核定位信号,
增强编辑效率
无菌、超低内毒素
在符合GMP的工厂进行
生产并进行QC测试
Different amounts of Cas9 were incubated with the same amount of excess gRNA and plasmid for 60 minutes at 37°C. When using 400-200 ng Acro Cas9, the cutting efficiency is greater than 90%. In comparison, when using a 200 ng Competitor T, the cutting efficiency is only about 50%.
The TCR knockout efficiency with GMP GENPower™ NLS-Cas9 Nuclease in human primary T cells, GMP GENPower™ NLS-Cas9 Nuclease achieved over 95% knockout efficiency.
慢病毒包装质粒的生产是进行CAR-T细胞制备的一个关键环节。在此过程中会产生核酸残留,宿主核酸的残留因其可能带来的传染性或者致瘤的风险而被作为生物制品安全监管中的重要一项。
ACROBiosystems百普赛斯依托酶改造技术平台,通过协同AI模拟计算和高通量筛选,自主开发的GMP级别全能核酸酶(常规版本:GMP-NUES19 ,耐高盐版本:GMP-NUES13)是生物药工艺流程中去除核酸污染的理想选择!
盐浓度适应范围广,中、
高盐条件下仍具有高酶活
稳定性高,37°C保存21天,
酶活不受影响
下游工艺无需透析、脱盐,
节省时间
GMP条件生产,满足从研发到
生产的大规模使用需求
GMP Salt Active GENIUS™Nuclease (货号:GMP-NUES13) 在0-500mM NaCl条件下,均能保持高酶活;且0-500mM条件下GMP-NUES13的酶活显著优于竞品。
对6.5E+06cell/mL HEK293的细胞破碎液,使用40U/mL耐盐核酸酶处理30min后再利用qPCR检测宿主细胞DNA残留量,结果显示ACRO GMP Salt Active GENIUS™Nuclease (货号:GMP-NUES13) 处理后的DNA残留极低,核酸清除效果优于竞品。
资源分享