CDMO solutions

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CDMO solutions

We provide GMP-grade CDMO solutions tailored for scalability, commercialization, and expert preclinical EV testing. Quality assurance is central to our services, with rigorous control from raw materials to product release, ensuring reliability. This commitment guarantees meticulous evaluation of EV behavior across diverse diseased models.

Preclinical testing
In vitro:

  • Stability testing
  • Pharmacology and pharmacodynamics studies
  • Uptake experiments
  • Cell cycle analysis
  • Cell apoptosis analysis
  • Cell migration transwell assays
  • Cell invasion tests
  • Functional assays

In vivo:

We offer EV function research models for diverse diseases such as respiratory, circulatory, digestive, urinary, motor, endocrine, nervous, skin, eye diseases, and tumors in vivo. Additionally, tailored EV administration modes are available to meet specific requirements.

Featured case study: Red blood cell-derived EVs (RBCEVs)
We are experts in utilizing RBCEVs for efficient and targeted delivery of therapeutic agents for a broad spectrum of diseases.

RBCEVs exhibit remarkable potential in gene therapy:

  • Durable, high-amplitude gene expression
  • Re-dosable feature
  • Ability to impact multiple cell types with precision
  • Largest payload capacity among similar delivery systems
  • Promising candidates for targeted gene therapy applications

RBCEVs offer a versatile delivery system for a diverse range of nucleic acid payloads through various routes such as nebulized & inhaled, sub-retinal, intravenous, and intrathecal administration, unlocking a multitude of therapeutic possibilities.

Representative data

RBCEV-nucleic acid: in vitro therapeutic effect

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-nucleic acid: in vivo therapeutic effect

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-nanobody-nucleic acid: in vitro therapeutic effect

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-nanobody-nucleic acid: in vivo therapeutic effect

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-fluorophore conjugate: robust payload expression in the CNS

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).