Soluciones CDMO

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Soluciones CDMO

Ofrecemos soluciones CDMO de grado GMP diseñadas para escalabilidad, comercialización y pruebas EV preclínicas expertas. La garantía de calidad es central en nuestros servicios, con un control riguroso desde las materias primas hasta la liberación del producto, asegurando fiabilidad. Este compromiso garantiza una evaluación meticulosa del comportamiento de EV en diversos modelos de enfermedades.

Pruebas preclínicas
In vitro:

  • Pruebas de estabilidad
  • Estudios de farmacología y farmacodinamia
  • Experimentos de captación
  • Análisis del ciclo celular
  • Análisis de apoptosis celular
  • Ensayos de migración celular en transwell
  • Pruebas de invasión celular
  • Ensayos funcionales

In vivo:

Ofrecemos modelos de investigación de función de EV para diversas enfermedades como respiratorias, circulatorias, digestivas, urinarias, motoras, endocrinas, nerviosas, de la piel, oculares y tumores in vivo. Adicionalmente, se ofrecen modos de administración de EV adaptados para cumplir con requisitos específicos.

Estudio de caso destacado: EVs derivados de glóbulos rojos (RBCEVs)
Somos expertos en utilizar RBCEVs para la entrega eficiente y dirigida de agentes terapéuticos para un amplio espectro de enfermedades.

Los RBCEVs muestran un potencial notable en la terapia génica:

  • Expresión génica duradera y de gran amplitud
  • Característica de re-dosificación
  • Capacidad para impactar múltiples tipos celulares con precisión
  • Mayor capacidad de carga útil entre los sistemas de entrega similares
  • Candidatos prometedores para aplicaciones de terapia génica dirigida

Los RBCEVs ofrecen un sistema de entrega versátil para una amplia gama de cargas útiles de ácidos nucleicos a través de diversas vías como la nebulización e inhalación, la administración subretiniana, intravenosa e intratecal, desbloqueando una multitud de posibilidades terapéuticas.

Datos representativos

RBCEV-ácido nucleico: efecto terapéutico in vitro

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-ácido nucleico: efecto terapéutico in vivo

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-nanocuerpo-ácido nucleico: efecto terapéutico in vitro

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-nanocuerpo-ácido nucleico: efecto terapéutico in vivo

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-conjugado de fluoróforo: expresión robusta de carga útil en el SNC

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).