CDMO解决方案

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CDMO 解决方案

我们提供专为可伸缩性、商业化和专业临床前EV测试定制的GMP级CDMO解决方案。质量保证是我们服务的核心，从原材料到产品发布进行严格控制，确保可靠性。这一承诺保证对不同疾病模型下EV行为的细致评估。

临床前测试
体外：

  • 稳定性测试
  • 药理学和药效学研究
  • 摄取实验
  • 细胞周期分析
  • 细胞凋亡分析
  • 细胞迁移Transwell测定
  • 细胞侵袭测试
  • 功能性测定

体内：

我们为呼吸系统、循环系统、消化系统、泌尿系统、运动系统、内分泌系统、神经系统、皮肤、眼部疾病以及肿瘤等多种疾病提供EV功能研究模型。此外，我们还提供定制的EV给药模式，以满足特定要求。

特色案例研究：红细胞源EVs（RBCEVs）
我们是利用RBCEVs进行治疗剂的高效和定向传递，适用于广泛疾病谱的专家。

在基因疗法中，RBCEVs展现出显著潜力：

  • 持久、高振幅的基因表达
  • 可重复给药特性
  • 精准影响多种细胞类型的能力
  • 在类似传递系统中拥有最大的载荷能力
  • 是针对性基因治疗应用的有前途的候选方案

RBCEVs通过雾化吸入、眼下亚视网膜、静脉内和脑脊液内给药等多种途径，为多样的核酸载荷提供了一种多功能传递系统，开启了多种治疗可能性。

代表性数据

RBCEV-核酸：体外治疗效果

Immunomodulatory RNA (immRNA)-loaded RBCEVs markedly increased the expression of RIGI, encoded by Ddx58, along with numerous downstream effector genes in breast cancer 4T1 and CA1a cells (top two images). Furthermore, immRNA-loaded RBCEVs triggered apoptosis in breast cancer 4T1 and CA1a cells, as confirmed by PI/AnxV staining (bottom two images).

RBCEV-核酸：体内治疗效果

ImmRNA-loaded RBCEVs suppress tumor growth. The schematic illustrates the treatment of mouse 4T1 mammary tumors in BALB/c mice through intratumoral delivery of immRNA in RBCEVs (top image). Tumor volume significantly decreased in mice injected intratumorally with RBCEVs containing immRNA (bottom left image). RT-qPCR analysis of RIG‐I pathway gene expression revealed that immRNA-loaded RBCEVs led to significantly higher expression levels of Ddx58, Mda5, Irf7, Ifnb, Rsad2, and Isg56 in the dissociated tumor cells (bottom right image).

RBCEV-纳米抗体-核酸：体外治疗效果

Conjugation of RBCEVs with an EGFR‐binding nanobody promotes the specific delivery of immRNA to metastatic breast cancer cells. The schematic illustrates the modification of RBCEVs: RBCEVs were conjugated with an anti‐EGFR nanobody and loaded with immRNA (top image). Flow cytometry analysis revealed that the CFSE fluorescence intensity in 4T1‐hEGFR cells treated with EGFR‐targeting CFSE‐labelled RBCEVs was approximately 28.6‐fold higher than that in 4T1‐hEGFR cells treated with non‐targeted CFSE‐labelled RBCEVs (bottom images).

RBCEV-纳米抗体-核酸：体内治疗效果

Intrapulmonary delivery of EGFR-targeted immRNA-loaded RBCEVs suppresses breast cancer lung metastasis. Schematic shows treatments for mice with lung metastasis (top image). Mice treated with targeted immRNA-loaded RBCEVs displayed significantly reduced lung metastatic areas (bottom left image). RT-qPCR of lung lysate revealed immRNA-loaded RBCEVs activated the RIG-I cascade. While RLR genes showed no substantial increase, Ifnb, Isg56, and Rsad2 significantly rose with EGFR-targeted RBCEVs compared to non-targeted ones. Flow cytometry indicated increased infiltration of neutrophils, NK cells, macrophages, cDCs, and CD8+ T cells in treated mouse lungs, with EGFR-targeted RBCEVs enhancing these effects (bottom right images).

RBCEV-荧光素共轭物：CNS中强劲载荷表达

Intrathecal dosing of loaded RBCEV delivered robust payload expression in mouse CNS. Schematic representation of the Intrathecal injection of DIR-CFSE labeled RBCEVs in C57BL/6 mice, followed by a 24-hour interval for subsequent analysis (top image). The brain exhibited the highest DiR fluorescence intensity in comparison to other organs (bottom image).
Intrathecal injection of RBCEVs loaded with CAG-eGFP leads to transgene expression in the cerebellum. Immunohistochemical analysis demonstrated a notably elevated GFP intensity (green) in the cerebellum of mice treated with RBCEVs loaded with CAG-eGFP. Neurons were counterstained with Hoechst dye (blue).