选择语言

体内CAR-T细胞疗法开发解决方案

近年来,体内(In Vivo)CAR-T细胞疗法在癌症免疫治疗领域取得了革命性突破,与传统的体外(Ex Vivo)CAR-T疗法不同,In Vivo CAR-T技术通过递送载体将CAR编码基因直接导入患者体内的T细胞,实现免疫细胞的重编程。这一创新疗法不仅简化了治疗流程,还显著降低了生产成本,为癌症患者带来了更便捷、更高效的治疗选择。

体内CAR-T细胞疗法的主要优势

治疗时间短:利用现成的重编程载体使得体内CAR-T疗法比体外方法快几周。
治疗成本低:每剂成本预计低至5000美元,仅为当前传统CAR-T疗法成本的一部分。
改善患者预后:患者保留完整的免疫系统,无需接受高强度化疗,减少免疫细胞耗竭,提高抗癌效果。
Trends Pharmacol Sci. 2024;45(5):406-418.

Trends Pharmacol Sci. 2024;45(5):406-418.

早期研发
抗体筛选
CAR DNA或mRNA载体设计
递送系统设计
体外和体内疗效早期测试
毒性研究
CMC
质粒DNA生产
mRNA生产与纯化
Ab-LNPs的开发及表征
灌装与成品工艺
供应链和物流管理
毒性研究
临床
安全性与疗效评估
剂量确定
副作用监测
长期影响研究

体内CAR-T细胞疗法工作流程

mRNA质量控制

我们提供一系列高品质的CMC质控检测试剂盒,专为mRNA产品质量控制设计,确保mRNA产品在治疗和研究应用中的完整性和安全性。这些试剂盒经过严格的方法学验证,可准确评估mRNA的纯度、完整性和功能性。

Ab-LNPs抗体密度优化

对于体内CAR-T疗法,递送载体的靶向性至关重要。为了提高递送效率,通常在递送载体如脂质纳米颗粒(Lipid Nanoparticles,LNP)表面连接靶向抗体,形成抗体偶联LNP(Ab-LNPs),从而显著增强其对特定细胞的特异性,实现精准治疗。常见的靶向抗体包括CD4、CD8、CD3、CD5、CD7等,这些抗体能够有效引导LNP精准识别并定位到特定细胞,如T细胞或B细胞。LNP偶联抗体的密度和活性是Ab-LNPs质量、安全性和疗效的关键指标。我们开发了一系列具有稳定F/P比率和高活性的荧光标记蛋白,这些蛋白经过严格验证,适用于Ab-LNPs抗体密度的定量分析。

即用型设计,可提供多种浓度的流式细胞术验证数据
Ready-to-use due to validation data with various concentration by flow cytometry

1e5 of Mouse Anti-CD7 antibody coupled beads (5.5 μm) were stained with different concentration of Alexa Fluor 647-Labeled Human CD7 Protein, His Tag (Cat. No. CD7-HA2H4) and negative control protein respectively, AF647 signal was used to evaluate the binding activity (QC tested).

Ready-to-use due to validation data with various concentration by flow cytometry

1e5 of Mouse Anti-CD8 antibody coupled beads (5.5 μm) were stained with different concentration of Alexa Fluor 488-Labeled Human CD8 alpha Protein, His Tag (Cat. No. CDA-HA2H6) and negative control protein respectively, AF488 signal was used to evaluate the binding activity (QC tested).

Ready-to-use due to validation data with various concentration by flow cytometry

1e5 of Mouse Anti-CD4 antibody coupled beads (5.5 μm) were stained with different concentration of Alexa Fluor 647-Labeled Human CD4 Protein, His Tag (Cat. No. CD4-HA2H8) and negative control protein respectively, AF647 signal was used to evaluate the binding activity (QC tested).

高稳定性
High stability

Alexa Fluor 488-Labeled Human CD7 Protein, His Tag (Cat. No. CD7-HA2H9) is stable at 25℃ for 48 hours, equivalent to store at -70℃ for 2 years and freezing and thawing 3 times without performance reduction.

高批间一致性
High batch-to-batch consistency

Binding activity of three different lots of Alexa Fluor 488-Labeled Human CD7 Protein, His Tag against Anti-CD7 CAR-293 cells was evaluated by flow cytometry. The result shows very high batch-to-batch consistency.

结合活性不受标记影响
No effect on binding activity

Immobilized Alexa Fluor 647-Labeled Human CD7 Protein, His Tag (Cat. No. CD7-HA2H4) at 1 μg/mL (100 μL/well) can bind Anti-CD7 antibody, Mouse IgG1 with a linear range of 0.05-3 ng/mL (Routinely tested). Labeling with fluorescent dyes did not affect their activity.

CAR检测

我们还开发了一系列高品质CAR靶点蛋白,包括荧光标记和生物素标记等蛋白类型,专为CAR表达评估而设计。

Resources

  • 体内CAR-T细胞疗法开发解决方案
  • T细胞培养生产原料
  • mRNA质量控制
  • Ab-LNPs抗体密度优化
  • CAR检测
  • Resources